Aesthetic Advertising Compliance & Mandatory Statements | MObyJC
Advertising Compliance

Advertising compliance,
made clear.

Everything aesthetic injectors in Aotearoa need to promote their practice safely, legally, and with confidence. Mandatory consumer statements, the rules that govern them, and the practical guidance to apply both. Bookmark this page. Share it with your team.

Why this exists

Why advertising compliance matters.

Advertising in aesthetic medicine is not just promotion. It is a regulated activity that affects patient safety, professional reputation, and public trust.

As an injector or healthcare provider in New Zealand, you are legally responsible for ensuring your advertising is truthful and not misleading, includes balanced information about risks and benefits, promotes only on-label uses of prescription medicines, and complies with Medsafe, the ASA Therapeutic and Health Advertising Code, and the Medicines Act 1981.

Non-compliance can lead to formal complaints, fines, takedown orders, and professional misconduct investigations. Most breaches are unintentional and most are avoidable when you have the right reference material at hand. That is what this page is for.

The Stakes

What happens if you get it wrong.

Section 20 of the Medicines Act 1981 sets out the financial penalties for breaching advertising restrictions on prescription medicines. These are not theoretical figures.

$20,000

Individual Fine

$100,000

Body Corporate Fine

Beyond financial penalties, breaches can trigger:

Formal complaints to the Advertising Standards Authority. Outcomes are published on the ASA website regardless of whether the complaint is upheld. The complainant's name is generally not published, but yours is.

Medsafe investigations. Medsafe enforces the Medicines Act and can require takedowns, issue warnings, or refer matters for prosecution.

Professional misconduct investigations. The Nursing Council, Medical Council, and other regulatory bodies can investigate advertising breaches as professional conduct issues, with consequences for your registration.

Industry body responses. Bodies such as the Clinical Aesthetic Network of New Zealand (CANNZ) and the New Zealand Society of Cosmetic Medicine can investigate breaches under their codes of practice.

The Quick Reference

What you can and can't do.

A side-by-side reference for the most common advertising decisions you will face.

Allowed

  • Promote on-label indications for any prescription medicine
  • Use brand names with the relevant mandatory consumer statement attached and legible
  • Share your own, realistic, unaltered before-and-after images with patient consent
  • Use measured, balanced language such as "may help reduce fine lines"
  • Provide general educational information about treatment categories
  • Disclose paid partnerships and sponsored content clearly
  • Advertise the quality of your service, your team, and your clinic experience

Not Allowed

  • Promote off-label uses of prescription medicines (lip flip, masseter, DAO, neck)
  • Use brand names without the mandatory consumer statement
  • Use stock images, celebrity photos, or sponsor-supplied imagery in your ads
  • Make absolute claims like "eliminates wrinkles" or guarantee specific results
  • Offer discounts, giveaways, or prize draws on prescription medicines or medical devices
  • Use testimonials or reviews that reference prescription medicines or medical devices
  • Show identifiable patients or staff being injected in any advertising
The Critical Distinction

On-label vs off-label.

You may legally perform off-label treatments with proper consent. You cannot legally advertise them. The distinction is the foundation of compliant practice.

Each botulinum toxin brand has its own Medsafe-approved aesthetic indications. You can only advertise an indication for a specific brand if it is approved for that brand on the Medsafe data sheet. The tables below show approved aesthetic indications taken directly from the current New Zealand data sheets for each product.

Botox®
Approved Aesthetic Indications
Glabellar (frown) lines
Crow's feet
Forehead lines
Platysma prominence (Nefertiti / vertical neck bands)
Axillary hyperhidrosis (excessive sweating)
Source: Medsafe Data Sheet v18, 17 July 2025
Dysport®
Approved Aesthetic Indications
Glabellar (frown) lines
Lateral canthal lines (crow's feet)
Axillary hyperhidrosis (excessive sweating)
Source: Medsafe NZ Data Sheet, current version
Xeomin®
Approved Aesthetic Indications
Glabellar frown lines
Lateral periorbital lines (crow's feet)
Horizontal forehead lines
Source: Medsafe Data Sheet v5.2, December 2025
Off-Label Uses
Cannot be advertised for any brand
Lip flip
Gummy smile
Masseter / bruxism
DAO (depressor anguli oris)
Mentalis
Any other indication not listed on the relevant Medsafe data sheet

You may legally perform these treatments with proper consent, but you cannot advertise them under New Zealand law.

Important: If you advertise an indication for a specific brand that is not on its Medsafe data sheet, even if it is approved for a different brand, that is off-label advertising and may breach the Medicines Act 1981. Always verify against the current Medsafe data sheet before naming a specific brand in advertising.

Alternative phrasing such as "anti-wrinkle injections" or "wrinkle relaxer" does not exempt your post from these rules. The generic mandatory consumer statement is still required when you reference these terms, and you may only describe approved uses.

Imagery Standards

Before & after image requirements.

Before-and-after content has the highest potential to mislead, so the ASA and Medsafe apply the strictest standards. If you publish any of this content, every point below must be true.

  1. The image is included solely to provide accurate, useful information to prospective patients, not to make a sales claim.
  2. The result shown is realistic and representative of what an average patient could expect, not a best-case outlier.
  3. The patient featured was treated by you or your clinic personally. You cannot use a result from elsewhere.
  4. The image has not been altered, retouched, or filtered. No skin smoothing, no contrast tweaks, no AI enhancement.
  5. The "before" and "after" use the same lighting, contrast, background, framing, camera angle, and exposure. Any difference in technique is misleading.
  6. The patient's posture, clothing, and make-up are consistent across both images.
  7. You have the patient's full informed written consent to use the image, ideally with a separate consent form for promotional use.
  8. The qualifier "Individual results may vary" is included clearly within the post or image.

Two further restrictions worth noting: full-face images are considered testimonials if the patient is identifiable, even with eyes blurred or covered. The current standard requires that the image be cropped to the treated area only, or that the entire identity be concealed. Eye blurring alone is not sufficient.

Before-and-after images depicting any non-approved use of a prescription medicine cannot be used in advertising at all, regardless of consent or quality. A before-and-after of a lip flip, for example, cannot be advertised even if everything else on this checklist is met.

A Critical Distinction

Patient experience vs testimonial.

Testimonials about prescription medicines or medical devices are prohibited under Section 58 of the Medicines Act. Patient experience content is allowed, but the boundary is narrow.

Testimonials about prescription medicines or medical devices are prohibited under Section 58 of the Medicines Act. Patient experience content is allowed, but the boundary between the two is narrow.

Patient Experience (Allowed)

  • The patient describes their current situation in the present tense (frown lines, skin laxity, feeling self-conscious)
  • The patient describes what they would like to change about their appearance
  • Generic discussion of visiting your clinic, the booking experience, the team
  • Aspirational language in the future tense about how they hope to feel

Testimonial (Prohibited)

  • Any reference to a specific brand or generic prescription medicine
  • Claims about a treatment's effectiveness or outcome
  • Recommendations of you, your clinic, or specific products
  • Re-sharing or reposting patient or influencer content involving products
  • Showing an identifiable patient being treated alongside outcome claims, brand product references, or endorsement framing

Procedural imagery is generally permitted when the patient is not identifiable (no face, no distinctive features), no brand product is visible (no vials, packaging, or labels in frame), and no outcome claim is made. Generic injection technique shots used for educational or process content do not constitute testimonials under the ASA Therapeutic and Health Advertising Code or Section 58 of the Medicines Act. The line is crossed when identifiability, branding, or claims are added to the picture.

If you are uncertain whether content crosses the line, the conservative approach is to assume it does. The ASA and Medsafe both interpret these rules strictly.

Third-Party Posts

Influencers & client posts.

When someone else posts about your practice, the regulations still apply. Here is how to handle the most common scenarios.

A client tags you in a post about their treatment. Do not share, repost, or screenshot the content. Tagging by the client does not absolve you of advertising responsibility, and resharing makes the post your advertisement. If the post references a prescription medicine or medical device, it cannot be reposted at all. If the post is about the experience of visiting your clinic without product references, you may share with caution and only after confirming the post does not contain non-approved use, brand references, or testimonial content.

An influencer offers to post about your services. Treat any arrangement involving free product, free treatment, or payment as advertising. The influencer's post must follow the same rules as your own advertising, including mandatory consumer statements and clear "Ad" or "Advertisement" labelling. Influencers cannot describe their assessment of a prescription medicine or medical device, even in their own words, because that constitutes a testimonial.

A staff member appears in a treatment image. Identifiable staff members performing or being shown alongside a procedure becomes professional endorsement, which is prohibited under Section 58 of the Medicines Act. If you wish to feature a treatment in a video or image, you must conceal the identity of both the practitioner and the patient.

Hashtags count. A post with no brand name in the body but with a hashtag like #botoxnz, #dysport, or #antiwrinkle still requires the relevant mandatory consumer statement. The ASA treats hashtags as integral to the advertisement.

Reviews

Reviews on social media.

You cannot ask patients to leave reviews about prescription medicine or medical device treatments. Where you can, turn reviews off. Where you cannot, monitor and moderate.

Under New Zealand's self-regulatory model, the page owner is liable for reviews and comments that breach the Medicines Act, the ASA Code, or the Fair Trading Act. This applies whether the comment came from a customer, an unknown user, or a competitor.

Facebook reviews can be turned off in your page settings, and we recommend doing so if your clinic primarily delivers prescription or medical device treatments. Google reviews cannot be turned off. Your obligations there: monitor regularly, do not solicit them, do not respond in a way that confirms specific treatments, and flag any review that breaches Google's policies.

Reviews focused on staff friendliness, clinic environment, booking experience, or how the patient was made to feel are generally fine. Reviews that name a prescription medicine or medical device, describe treatment outcomes, or recommend specific products are not. Remove these where you control the platform. Where you don't control the platform (such as Google), do not engage with them in a way that endorses or confirms the product reference.

Social & Digital

Social media & digital advertising.

The platform-specific rules that apply to your Instagram, Facebook, TikTok, and LinkedIn content.

If your post mentions a brand name, the mandatory consumer statement must be included in the same post. Not in a separate carousel slide, not in a follow-up story, not via a link or QR code. The statement and the brand reference must appear together.

In tight spaces such as Instagram Stories or short-form video, use the short consumer mandatory statement with a visible link to www.medsafe.govt.nz. The short version is acceptable for digital media where space is genuinely constrained.

The statement must be legible. If a viewer has to zoom in to read it, that is not legible. If your text is so small that only a few words fit on screen at a time, that is not legible. The ASA has previously ruled that mandatory information present but unreadable is treated as if it were not present at all.

Hashtags trigger the same requirements as body text. #botoxnz, #dysport, #antiwrinkle, and any other brand-name or generic-treatment hashtag requires the relevant mandatory consumer statement to be visible in the same post.

The Fine Print That Cannot Be Fine

Statement size & legibility.

There is no longer a specific minimum font size in the legislation, but legibility is required and assessed practically. Here are the rules in plain language.

The statement must be readable at 100% zoom on the device most users will see it on. For mobile-heavy platforms like Instagram and TikTok, this means readable on a smartphone at default settings.

If the viewer must scroll horizontally or vertically through more than a few words at a time to read the statement, it is not considered legible. Long blocks of tiny text in image overlays generally fail this test.

Hyperlinks and QR codes cannot replace the mandatory statement. Linking to www.medsafe.govt.nz is fine as a supplement, but the statement itself must appear in the advertisement. This applies to every channel without exception.

Mandatory information can be split across a multi-image carousel post, with the statement spread across slides to ensure each slide remains legible. A single static image post often does not have enough space for both a brand reference and a fully legible mandatory statement.

Mandatory information can be included in the text caption of a Facebook or Instagram post, which is often the cleanest solution for visual-heavy content.

The Heart of This Page

Mandatory consumer statements.

When you reference a generic treatment or specific brand in any advertising, you are legally required to include the relevant consumer statement, reproduced exactly. These statements come from the manufacturers and cannot be modified, paraphrased, or shortened.

Two important rules. If you are advertising a generic treatment without a specific product (for example "anti-wrinkle injections"), you must use the generic mandatory consumer statement. If you are referencing a specific product (for example "Xeomin treatment"), you must use the brand-specific statement. Some posts may require both.

Use the short statement when your advertisement does not include therapeutic or promotional claims, or where space is constrained (such as Instagram Stories). Use the long statement when your advertisement includes therapeutic claims, comparisons, or detailed promotional content.

Statements are organised alphabetically below. Use the letter index to jump to a specific brand. Reproduce each statement exactly as it appears, including the trademark symbols, parent-company attribution, and contact details.

B 4 entries

Belkyra®

Prescription Medicine
Short Consumer Mandatory Statement

Belkyra® Prescription Medicine BELKYRA® injection non-surgically reduces fat under the chin, resulting in a more contoured neck profile and jawline. Belkyra® has risks and benefits. Ask your doctor if Belkyra® is right for you. Deoxycholic acid 10mg/ml. For product information check with your doctor or the Consumer Medicine Information on www.medsafe.govt.nz. Allergan (NZ) Limited, Auckland.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

BELKYRA® injection is a prescription medicine containing 10mg/mL deoxycholic acid. It is used for the improvement in the appearance of moderate to severe convexity or fullness associated with fat below the jaws in adults. Do not use in people allergic to this medicine, with infection at site of injection, pregnancy, and lactation. Possible side effects include headaches, difficulty swallowing, nausea, skin tightness, hypertension, injection site bruising/pain/swelling/numbness/redness/tingling/hardness/itching/discolouration/formation of small areas of hardness/warmth and injection site nerve injury. BELKYRA® treatment is not funded on the New Zealand Pharmaceutical Schedule. You will need to pay for this medicine. Normal Doctors visit fees apply. BELKYRA® treatment should be administered only by trained medical professionals. Speak to your specialist about your own situation and about the benefits/risks of this procedure in appearance medicine. For further information, the Data Sheet and Consumer Medicines Information can be accessed at www.medsafe.govt.nz or ask your doctor. If you have any side effects or concerns speak to your doctor. Note: Results from BELKYRA® treatment usually last up to 4 years. Allergan New Zealand Limited, Auckland.

Reproduce verbatim. Do not modify or shorten.

Belotero®

Medical Device Class III
Short Consumer Mandatory Statement

Belotero® Medical Device Class III to smooth facial wrinkles and folds, correct facial atrophic scars, restore or enhance the lips or restore facial volume Belotero® has risk and benefits. Ask your doctor if Belotero is right for you. For product information check with your doctor or from product details with the supplier. Contains Sodium Hyaluronate Gel. Merz, Sydney. Distributed by Healthcare Logistics, Auckland.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

Belotero® is a Class III medical device to smooth facial wrinkles and folds, correct facial atrophic scars, restore of enhance the lips or restore facial volume. Belotero has risk and benefits. Ask your specialist if Belotero® is right for you. Contains transparent cross-linked sodium hyaluronate gel of nonanimal origin with lidocaine 0.3% to reduce local pain. Do not use if you have a skin inflammation or a skin infection or until the infection is healed. Precautions. There is a risk of infection. Tell your doctor if you are on blood-clotting medicines as there could be an increased risk of bruising or bleeding at the injection site. Possible side effects: swelling, bruising, redness hardening of the skin, pain, altered colour or itching. Lasts 6-12 months. You will need to pay for this product and doctor's fees apply. Merz, Sydney. Distributed by Healthcare Logistics, Auckland.

Reproduce verbatim. Do not modify or shorten.

Belotero® Revive

Medical Device
Consumer Mandatory Statement

BELOTERO® Revive is an injectable resorbable implant intended to revitalize facial skin through rehydration of dry and very dry skin, improvement of elasticity and firmness, and smoothening of superficial fine lines by reducing skin roughness. Belotero® Revive is indicated for revitalization of early-onset photodamaged facial skin, as characterized by dehydration, loss of elasticity and firmness, and presence of superficial fine lines. You should tell your practitioner and avoid treatment with BELOTERO® Revive if you: have had an allergic reaction to any of the ingredients; if you tend to develop keloids or heavy scars; have any bleeding disorders, poor wound healing, inflamed or infected skin, active auto-immune disease or general infection; are under the age of 18; are pregnant or breastfeeding. Please inform your practitioner of any diseases you have or have had. These include in particular cardiovascular diseases, autoimmune diseases, diabetes, epilepsy, liver or kidney problems, skin infections or severe allergies. If you take medication or vitamins, have had previous cosmetic procedures, or have been treated with other implants, please inform your practitioner. Always read the label and consult your Healthcare Professional for more information. This medical device must be administered by a Healthcare Professional. Copyright © 2023. Pharmacy Retailing NZ Limited t/a Health Care Logistics (HCL) 58 Richard Pearse Drive, Mangere, Auckland 2022. All rights reserved. Belotero® and Merz Aesthetics are registered trademarks of Merz Pharma GMbH & Co. KGaA.

Reproduce verbatim. Do not modify or shorten.

Botox®

Prescription Medicine
Short Consumer Mandatory Statement

Botox®, Prescription Medicine for the treatment of frown lines and crow's feet around the eyes. Botox® has risks and benefits. Ask your doctor if Botox® is right for you. Botulinum toxin type A 50, 100, 200 Units. For product information check with your doctor or Consumer Medicine Information on www.medsafe.govt.nz. Allergan, Auckland.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

Botox® is a prescription medicine containing 100 units of Clostridium Botulinum Type A toxin complex for injection. It is used for the treatment of severe frown lines and associated "crow's feet" around the eyes. It should be administered only by trained medical professionals. Talk to your specialists about the benefits/risks of this procedure in appearance medicine. Cautions: people with neuro-muscular transmission disorders, presence of infection at site of injection, pregnancy and lactation. Possible side effects include headaches, pain, burning sensation or redness at injection site, temporary local muscle weakness including eyelid droop, decreased sensation and nausea. If you have side effects or concerns, talk to your doctor. A charge applies. Allergan Pharmaceutical, Auckland.

Reproduce verbatim. Do not modify or shorten.

D 1 entry

Dysport®

Prescription Medicine
Short Consumer Mandatory Statement

Dysport®, Prescription Medicine for the treatment of frown lines and crow's feet around the eyes. Dysport® has risks and benefits. Ask your doctor if Dysport® is right for you. Botulinum toxin type A 300 or 500 Ipsen Units. For product information check with your doctor or Consumer Medicine Information on www.medsafe.govt.nz. Click for further details Galderma, Auckland.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

Dysport® is a prescription medicine for the treatment of frown lines, horizontal forehead lines and crow's feet around the eyes. Dysport® has risks and benefits. Ask your doctor if Dysport is right for you. If you have side effects see your doctor. You will need to pay for Dysport, and clinic fees will apply. For details on precautions & side effects consult your healthcare professional or the Consumer Medicine Information (CMI) at www.medsafe.govt.nz. Dysport lasts about 4-6 months and further courses of treatment may be necessary. Should only be administered by trained medical professionals. Contains 500 units of clostridium botulinum Type A toxin. Galderma (NZ) Limited, Auckland.

Reproduce verbatim. Do not modify or shorten.

E 1 entry

e.p.t.q.

Medical Device
Consumer Mandatory Statement

e.p.t.q. Lidocaine is a sterile, non-pyrogenic, viscoelastic, colourless, transparent gel composed of cross-linked sodium hyaluronate gel of non-animal origin with 0.3% lidocaine hydrochloride in a physiologic phosphate buffer. e.p.t.q. Lidocaine is an injectable gel (also called a dermal filler) used for the correction of nasolabial folds. e.p.t.q. Lidocaine is produced with hyaluronic acid (HA), the HA of the gel is made from a non-animal source. e.p.t.q. Lidocaine should not be used on patients: with known hypersensitivity to any of its components; presenting with a general infection, inflammatory or infectious cutaneous problems; with history of severe multiple allergies or anaphylactic shock; prone to hypertrophic scars/keloids or streptococcal diseases; in patients presenting with porphyria; under 18 years of age; in pregnancy or lactation; others. See full Instructions for Use before prescribing for full safety information, available from www.xytide.co.nz. Copyright© 2024. Xytide Biotech Pty Ltd. Always read the label and follow the instructions. This medical device must be administered by a Healthcare Professional. New Zealand Sponsor Xytide Biotech NZ Pty Ltd (NZBN 9429049668612) C/O Alliott Ltd, Level 2, 142 Broadway, Newmarket, Auckland 1023 NZ. For more information please phone +61 1800 570 036

Reproduce verbatim. Do not modify or shorten.

G 3 entries

Generic Botulinum Toxin Type A

Prescription Medicine (generic)
Short Consumer Mandatory Statement

Botulinum toxin injections are prescription medicines for the treatment of frown lines, horizontal forehead lines and crow's feet around the eyes. Botulinum toxin injections have risks and benefits. Ask your doctor if botulinum toxin injections are right for you. For further information ask your doctor or go to www.medsafe.govt.nz.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

Botulinum toxin injections are prescription medicine for the treatment of frown lines, horizontal forehead lines and crow's feet around the eyes. Botulinum toxin injections have risks and benefits. Ask your doctor if botulinum toxin injections are right for you. If you have side effects, see your doctor. You will need to pay for your botulinum toxin injection and clinic fees will apply. For details on precautions & side effects consult your doctor or go to www.medsafe.govt.nz. Botulinum toxin injections last about 4 months and further courses of treatment may be necessary. Should only be administered by trained medical professionals.

Reproduce verbatim. Do not modify or shorten.

Generic Dermal Fillers

Medical Device (generic)
Short Consumer Mandatory Statement

Dermal filler injections are Medical devices for the treatment of loss of volume in the skin. Dermal fillers have risks and benefits. Ask your doctor if dermal filler injections are right for you. For further information ask your doctor or go to www.medsafe.govt.nz

Reproduce verbatim. Do not modify or shorten.

Generic Polydioxanone (PDO) Threads

Medical Device (generic)
Short Consumer Mandatory Statement

PDO threads are made from polydioxanone (PDO), a biocompatible polymer which undergoes complete hydrolytic degradation. The barbs, molded along the thread, anchor into the superficial dynamic fat pads under the skin, to reposition tissue for a non-surgical lift. This can aid in reducing the signs of ageing.

Reproduce verbatim. Do not modify or shorten.

I 8 entries

INNO-CE®

Medical Device Class III
Short Consumer Mandatory Statement

INNO-CE® is a product line of CE-Approved hyaluronic acid injectable class III medical devices for professional use only. Includes 7 products: 5 dermal fillers and 2 non-cross linked revitalising solutions. Formulated with Hyaluronic Acid at different densities. Filler product range is intended to restore changes to skin structure and promote volume restoration. Revitalisers are intended to provide deep moisturise and improve skin density. The INNO-CE® product line has risks and benefits. Ask your healthcare professional if INNO-CE® is right for you. For product information check with your healthcare professional or product details with the distributor, Intouch Medical Ltd, Auckland. Restricted to healthcare professionals with specialised training in dermal filler injection techniques.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

INNO-CE® is a product line of CE-Approved hyaluronic acid injectable class III medical devices for professional use only. The line includes 7 products: 5 dermal fillers and 2 non-cross linked revitalising solutions. Formulated at different densities. The MESHA® Dermal Filler product range is intended to restore changes to skin structure caused by aging fills in lines and creases in the facial skin, promotes volume restoration. Revitalisers are intended to provide deep moisturise and improve skin density. For full intended purpose and safety information, please refer to individual product Instructions for Use of MESHA®ESSENCE, MESHA®INTENSE, MESHA®DEEP, MESHA®, MESHA®SMILE, MESHA®SCARS, MOIST1.5, BI-DENS2.5. Precautions and Contraindications: Do not use in patients allergic to hyaluronic acid or any other component of the product. Do not use in patients with active skin infections in the treatment area. Pregnant or breastfeeding women. People with autoimmune diseases or under immunosuppressive treatment, would be a partial contraindication since it would depend on the patient's condition. Certain diseases such as porphyria or hemorrhagic disorders, a partial contraindication. For product information check with your healthcare professional. Exclusively for use by healthcare professionals trained in dermal injection techniques. ALWAYS READ THE LABEL AND FOLLOW INSTRUCTIONS FOR USE. THESE PRODUCTS ARE NOT AVAILABLE FOR PURCHASE BY THE GENERAL PUBLIC. KEEP OUT OF REACH OF CHILDREN. Vigilance contact (notification of an adverse event): [email protected] Distributor: Intouch Medical Ltd, 171 Marua Rd, Mt Wellington, Auckland, NZ.

Reproduce verbatim. Do not modify or shorten.

INNO-CE® BI-DENS 2.5

Medical Device Class III
Short Consumer Mandatory Statement

INNO-CE® BI-DENS 2.5 - class III medical device. Combines non-cross linked very high and high molecular weight hyaluronic acid (25mg/ml) for patients with skin laxity, dehydration, and loss of firmness, helping to improve skin texture and elasticity. BI-DENS 2.5 has risks and benefits. Ask your healthcare professional if BI-DENS 2.5 is right for you. For product information check with your healthcare professional or product details with the Distributor, Intouch Medical Ltd, Auckland. Exclusively for use by healthcare professionals trained in dermal injection techniques.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

INNO-CE® BI-DENS 2.5 - class III medical device. Combines non-cross linked very high and high molecular weight hyaluronic acid (25mg/ml) to enhance skin elasticity and firmness, supporting skin structure and hydration. Recommended for patients with skin laxity, dehydration, and loss of firmness, helping to improve skin texture and elasticity. INNO-CE® BI-DENS 2.5 has risks and benefits. Refer to instructions for use. Precautions and Contraindications: Do not use in patients allergic to hyaluronic acid or any other component of the product. Do not use in patients with active skin infections in the treatment area. Pregnant or breastfeeding women. People with autoimmune diseases or under immunosuppressive treatment, would be a partial contraindication since it would depend on the patient's condition. Certain diseases such as porphyria or hemorrhagic disorders, a partial contraindication. Ask your healthcare professional if INNO CE® BI-DENS 2.5 is right for you. For product information check with your healthcare professional or product details with the Distributor, Intouch Medical Ltd, 171 Marua Rd, Mt Wellington, Auckland, NZ. Exclusively for use by healthcare professionals trained in dermal injection techniques.

Reproduce verbatim. Do not modify or shorten.

INNO-CE® MESHA® Deep

Medical Device Class III
Short Consumer Mandatory Statement

INNO-CE® MESHA® Deep - class III medical device. A high-density dermal filler for restoring significant facial volume in deep anatomical areas such as the cheekbones and chin, and jawline. MESHA® Deep has risks and benefits. Ask your healthcare professional if it is right for you. For product information check with your healthcare professional or product details with the Distributor, Intouch Medical Ltd, Auckland. Restricted to healthcare professionals with specialised training in dermal filler injection techniques.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

INNO-CE® MESHA® Deep - class III medical device. A high-density dermal filler designed for restoring significant facial volume in deep anatomical areas such as the cheekbones and chin, ensuring a well-defined and natural contour. Best suited for patients needing restoration of lost facial volume in deep facial structures such as the cheekbones, chin, and jawline. Precautions and Contraindications: Do not use in patients allergic to hyaluronic acid or any other component of the product. Do not use in patients with active skin infections in the treatment area. Pregnant or breastfeeding women. People with autoimmune diseases or under immunosuppressive treatment, would be a partial contraindication since it would depend on the patient's condition. Certain diseases such as porphyria or hemorrhagic disorders, a partial contraindication. MESHA® Deep has risks and benefits. For product information check with your healthcare professional or product details with the Distributor, Intouch Medical Ltd, 171 Marua Rd, Mt Wellington, Auckland, NZ. Restricted to healthcare professionals with specialised training in dermal filler injection techniques.

Reproduce verbatim. Do not modify or shorten.

INNO-CE® MESHA® Essence

Medical Device Class III
Short Consumer Mandatory Statement

INNO-CE® MESHA® Essence - class III medical device. A hyaluronic acid dermal filler for subtle contouring and correction of superficial wrinkles. MESHA® Essence has risks and benefits. Ask your healthcare professional if it is right for you. For product information check with your healthcare professional or product details with the Distributor, Intouch Medical Ltd, Auckland. Restricted to healthcare professionals with specialised training in dermal filler injection techniques.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

INNO-CE® MESHA® Essence - class III medical device. A hyaluronic acid dermal filler with a smooth gel consistency, designed to restore lost facial volume and improve skin hydration. It is ideal for subtle contouring and correction of superficial wrinkles. Recommended for the correction of superficial wrinkles, mild facial volume loss, and early signs of skin aging. Precautions and Contraindications: Do not use in patients allergic to hyaluronic acid or any other component of the product. Do not use in patients with active skin infections in the treatment area. Pregnant or breastfeeding women. People with autoimmune diseases or under immunosuppressive treatment, would be a partial contraindication since it would depend on the patient's condition. Certain diseases such as porphyria or hemorrhagic disorders, a partial contraindication. MESHA® Essence has risks and benefits. For product information check with your healthcare professional or product details with the Distributor, Intouch Medical Ltd, 171 Marua Rd, Mt Wellington, Auckland, NZ. Restricted to healthcare professionals with specialised training in dermal filler injection techniques.

Reproduce verbatim. Do not modify or shorten.

INNO-CE® MESHA® Intense

Medical Device Class III
Short Consumer Mandatory Statement

INNO-CE® MESHA® Intense - class III medical device. An advanced hyaluronic acid-based filler for deep facial wrinkles, nasolabial folds, and areas with pronounced volume depletion that require enhanced support and definition. MESHA® Intense has risks and benefits. Ask your healthcare professional if it is right for you. For product information check with your healthcare professional or product details with the Distributor, Intouch Medical Ltd, Auckland. Restricted to healthcare professionals with specialised training in dermal filler injection techniques.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

INNO-CE® MESHA® Intense - class III medical device. An advanced hyaluronic acid-based filler with higher viscosity, formulated to correct deep wrinkles and facial folds while providing structural support and long-lasting volume. Indicated for deep facial wrinkles, nasolabial folds, and areas with pronounced volume depletion that require enhanced support and definition. Precautions and Contraindications: Do not use in patients allergic to hyaluronic acid or any other component of the product. Do not use in patients with active skin infections in the treatment area. Pregnant or breastfeeding women. People with autoimmune diseases or under immunosuppressive treatment, would be a partial contraindication since it would depend on the patient's condition. Certain diseases such as porphyria or hemorrhagic disorders, a partial contraindication. MESHA® Intense has risks and benefits. For product information check with your healthcare professional or product details with the Distributor, Intouch Medical Ltd, 171 Marua Road, Mt Wellington, Auckland. Restricted to healthcare professionals with specialised training in dermal filler injection techniques.

Reproduce verbatim. Do not modify or shorten.

INNO-CE® MESHA® Scars

Medical Device Class III
Short Consumer Mandatory Statement

INNO-CE® MESHA® Scars – class III medical device. A specially formulated filler for the improvement of atrophic and depressed scars. MESHA® Scars has risks and benefits. Ask your healthcare professional if it is right for you. For product information check with your healthcare professional or product details with the Distributor, Intouch Medical Ltd, Auckland. Restricted to healthcare professionals with specialised training in dermal filler injection techniques.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

INNO-CE® MESHA® Scars – class III medical device. A specially formulated filler for the treatment of atrophic scars, improving their depth and skin texture by promoting volume restoration. Recommended for the improvement of atrophic and depressed scars, enhancing skin smoothness and uniformity. Precautions and Contraindications: Do not use in patients allergic to hyaluronic acid or any other component of the product. Do not use in patients with active skin infections in the treatment area. Pregnant or breastfeeding women. People with autoimmune diseases or under immunosuppressive treatment, would be a partial contraindication since it would depend on the patient's condition. Certain diseases such as porphyria or hemorrhagic disorders, a partial contraindication. MESHA® Scars has risks and benefits. For product information check with your healthcare professional or product details with the Distributor, Intouch Medical Ltd, 171 Marua Rd, Mt Wellington, Auckland, NZ. Restricted to healthcare professionals with specialised training in dermal filler injection techniques.

Reproduce verbatim. Do not modify or shorten.

INNO-CE® MESHA® Smile

Medical Device Class III
Short Consumer Mandatory Statement

INNO-CE® MESHA® Smile – class III medical device. A soft, pliable hyaluronic acid indicated for lip augmentation, reshaping, and definition. MESHA® Smile has risks and benefits. Ask your healthcare professional if it is right for you. For product information check with your healthcare professional or product details with the Distributor, Intouch Medical Ltd, Auckland. Restricted to healthcare professionals with specialised training in dermal filler injection techniques.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

INNO-CE® MESHA® Smile – class III medical device. A soft, pliable hyaluronic acid filler specifically developed to enhance lip volume and shape, offering a natural and balanced aesthetic outcome. Indicated for lip augmentation, reshaping, and definition, particularly for patients seeking balanced and natural-looking volume enhancement. Precautions and Contraindications: Do not use in patients allergic to hyaluronic acid or any other component of the product. Do not use in patients with active skin infections in the treatment area. Pregnant or breastfeeding women. People with autoimmune diseases or under immunosuppressive treatment, would be a partial contraindication since it would depend on the patient's condition. Certain diseases such as porphyria or hemorrhagic disorders, a partial contraindication. MESHA® Smile has risks and benefits. For product information check with your healthcare professional or product details with the Distributor, Intouch Medical Ltd, 171 Marua Rd, Mt Wellington, Auckland, NZ. Restricted to healthcare professionals with specialised training in dermal filler injection techniques.

Reproduce verbatim. Do not modify or shorten.

INNO-CE® MOIST 1.5

Medical Device Class III
Short Consumer Mandatory Statement

INNO-CE® MOIST 1.5 - class III medical device. A non-crosslinked high molecular weight hyaluronic acid solution (15mg/ml) for patients with dehydrated and devitalized skin requiring intensive hydration and improved skin barrier function. MOIST 1.5 has risks and benefits. Ask your healthcare professional if Moist 1.5 is right for you. For product information check with your healthcare professional or product details with the Distributor, Intouch Medical Ltd, Auckland. Exclusively for use by healthcare professionals trained in dermal injection techniques.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

INNO-CE® MOIST 1.5 - class III medical device. A non-crosslinked hyaluronic acid solution (15mg/ml) designed to deliver immediate and long-lasting skin hydration by enhancing water retention and improving skin elasticity. Indicated for patients with dehydrated and devitalized skin requiring intensive hydration and improved skin barrier function. INNO-CE® MOIST 1.5 has risks and benefits. Refer to instructions for use. Precautions and Contraindications: Do not use in patients allergic to hyaluronic acid or any other component of the product. Do not use in patients with active skin infections in the treatment area. Pregnant or breastfeeding women. People with autoimmune diseases or under immunosuppressive treatment, would be a partial contraindication since it would depend on the patient's condition. Certain diseases such as porphyria or hemorrhagic disorders, a partial contraindication. Ask your healthcare professional if INNO-CE® MOIST 1.5 is right for you. For product information check with your healthcare professional or product details with the Distributor, Intouch Medical Ltd, 171 Marua Rd, Mt Wellington, Auckland. Exclusively for use by healthcare professionals trained in dermal injection techniques.

Reproduce verbatim. Do not modify or shorten.

J 2 entries

Jalupro®

Medical Device
Short Consumer Mandatory Statement

JALUPRO® Superhydro is a sterile resorbable injectable solution which acts as a deep biorevitalization treatment of Amino Acids Replacement Therapy, combined with biopeptides and a high concentration of high and low molecular weight hyaluronic acid. JALUPRO® Superhydro aims at supporting deep connective tissue, facial retaining ligaments and retinacular cutis, supporting the restoration of physiological condition. Distributed by EnVogue Skin NZ Pty Ltd. EnVogue Skin Pty Ltd. ABN 98 620 276 762. All brands and product names mentioned are trademarks of their respective holders. Copyright © 2024. All rights reserved.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

Jalupro Super Hydro: IMPORTANT INFORMATION: JALUPRO® Superhydro is a sterile resorbable injectable solution which acts as a deep biorevitalization treatment of Amino Acids Replacement Therapy, combined with biopeptides and a high concentration of high and low molecular weight hyaluronic acid. JALUPRO® Superhydro aims at supporting deep connective tissue, facial retaining ligaments and retinacular cutis, supporting the restoration of physiological condition, minimising the signs of aging, correcting the imperfections and defect of skin tissue. JALUPRO is composed of a pre filled syringe containing Amino Acids (Glycine, L-Proline, L-Leucine, L-Lysine), biopeptides and 32mg/ml hyaluronic acid. You should not receive treatment with any JALUPRO® SuperHydro product if you are below 18 years of age, if you are pregnant or breastfeeding, hypersensitivity to ingredients including hyaluronic acid, lidocaine or amide-type local anaesthetics, any areas of cutaneous inflammation and/or infections. Avoid makeup for 12 hours after injection and prolonged exposure to sunlight/UV light/extreme temperatures for 2 weeks. Distributed by EnVogue Skin NZ Pty Ltd. EnVogue Skin Pty Ltd. ABN 98 620 276 762. All brands and product names mentioned are trademarks of their respective holders. Copyright © 2024. All rights reserved.

Reproduce verbatim. Do not modify or shorten.

Juvederm®

Medical Device Class III
Short Consumer Mandatory Statement

Juvederm Ultraâ„¢ & Ultra Plusâ„¢, Medical Device Class III. For the filling of medium size and deep facial wrinkles by injection into the skin. Juvedermâ„¢ has risks and benefits. Ask your doctor if Juvedermâ„¢ is right for you. Volume (mL) 0.8mL Volume (mL) 1.0m hyaluronic acid + lidocaine. For product information check with your doctor or from product details with the supplier. Allergan, Auckland.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

Juvederm Ultraâ„¢ & Juvederm Ultra Plusâ„¢ are medical devices Class III for the filling of medium size and deep facial wrinkles by injection into the skin and for creating definition and volume in the lips. Contains 24mg/mL cross-linked hyaluronic acid. Juvederm has risks and benefits. Cautions: Use in an area that has been treated with another dermal filler, people with autoimmune disease, or who are pregnant, breastfeeding, under 18 years of age or have an increased susceptibility to keloid formation and hypertrophic scarring. People on blood thinning medicines. Possible side effects: injection site inflammatory reactions (redness/swelling, itching/pain on pressure) induration or nodules; discolouration; weak filling effect. If you have side effects or concerns speak to your doctor. Product and treatment costs will apply. Note: Juvederm treatment lasts about 12-24 months. For product information check with your doctor or product information at Allergan (NZ) Limited, Auckland.

Reproduce verbatim. Do not modify or shorten.

M 1 entry

MINTâ„¢

Medical Device
Consumer Mandatory Statement

MINTâ„¢ stands for "Minimally Invasive Non-surgical Thread". The threads are made from polydioxanone (PDO), a biocompatible polymer which undergoes complete hydrolytic degradation. The barbs, molded along the thread, anchor into the superficial dynamic fat pads under the skin, to reposition tissue for a non-surgical lift. This can aid in reducing the signs of ageing. Distributed by Mondeal Pty Ltd.

Reproduce verbatim. Do not modify or shorten.

P 1 entry

Profhilo®

Medical Device Class III
Short Consumer Mandatory Statement

Profhilo® Medical Device Class III. For the redefinition and laxity remodelling where skin laxity is a problem. Profhilo has risks and benefits. Contains low & high molecular weight hyaluronic acid (64mg/2ml). Ask your doctor if Profhilo is right for you. For product information check with your doctor or from product details with the Distributor Healthcare Logistics, Auckland.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

Profhilo®, containing low & high molecular weight hyaluronic acid, is a Class III medical device for the treatment of the face and body for contours redefinition and laxity remodelling where skin laxity is a problem. Profhilo® has risks and benefits. Do not use with treatments such a laser resurfacing or medium deep skin-peeling. Caution in people on blood thinning medicines. Do not inject into inflamed areas or intravenously or intramuscularly. Possible side effects: pain and swelling at injection site. Please refer to instructions for use, local distributor. Healthcare Logistics, Auckland.

Reproduce verbatim. Do not modify or shorten.

R 3 entries

Radiesse®

Medical Device
Consumer Mandatory Statement

Radiesse® injectable implant is intended for plastic and reconstructive surgery, including deep dermal and sub-dermal soft tissue augmentation of the facial area and dorsum of the hands. Radiesse® injectable implant is indicated for: the treatment of nasolabial folds, marionette lines or jawline; the augmentation of cheeks; the hand augmentation to correct volume loss in the dorsum of the hands; and the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse® (+) Lidocaine injectable implant is intended for plastic and reconstructive surgery, including deep dermal and sub-dermal soft tissue augmentation of the facial area and dorsum of the hands in adults. Radiesse® (+) Lidocaine injectable implant is indicated for: the treatment of nasolabial folds, marionette lines and jawline; the augmentation of cheeks; hand augmentation to correct volume loss in the dorsum of the hands; the restoration and/or correction of the signs of fat or volume loss (lipoatrophy) in the facial area and for rejuvenation of the hands fat loss (lipoatrophy) in people with human immunodeficiency virus. You should tell your practitioner and avoid treatment with Radiesse®/Radiesse® (+) Lidocaine if you: have had an allergic reaction to any of the ingredients or have severe allergies including anaphylaxis; if you tend to develop keloids or heavy scars; have any bleeding disorders, poor wound healing; inflamed or infected skin; are under the age of 18; are pregnant or breastfeeding. Please inform your practitioner of any diseases you have or have had. These include in particular cardiovascular diseases, autoimmune diseases, diabetes, tumors, skin infections or severe allergies. If you take medication or vitamins, have had previous cosmetic procedures, or have been treated with other implants, please inform your practitioner. Always read the label and consult your Healthcare Professional for more information. This medical device must be administered by a Healthcare Professional. Merz Australia Pty Ltd (ACN: 151 073 559) Sydney, Australia. NZ Distribution: Pharmacy Retailing NZ Limited t/a Health Care Logistics (HCL). 58 Richard Pearse Drive, Mangere, Auckland 2022. For more information please phone 0800 822 310.

Reproduce verbatim. Do not modify or shorten.

Restylane®

Medical Device Class III
Short Consumer Mandatory Statement

Restylane®, Medical Device Class III to smooth facial wrinkles and enhance lips by restoring volume and fullness. Restylane® has risk and benefits. Ask your doctor if Restylane® is right for you. For product information check with your doctor or from product details with the supplier. Stabilised Hyaluronic Acid 20mg/ml. Galderma, Australia, Sydney or distributor Healthcare Logistics, Auckland.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

Restylane® is a gel containing hyaluronic acid and lidocaine that is injected by a healthcare professional into or below the skin to smooth facial wrinkles and enhance lips by restoring volume and fullness. Restylane is a Class III medical device and has risks and benefits. Restylane® treatment may result in some redness, swelling, pain or tenderness, itching and/or bruising which may last a few days. Inflammatory reactions can begin up to two to four weeks after treatment in rare cases. See your healthcare professional if any side effects concern you. Exposure to excessive sunlight or extreme cold should be avoided until redness or swelling has resolved. Restylane® should not be used in an area where there is a nonresorbable implant or in irritated or infected skin, Restylane® should not be used in people taking blood thinning medicines or who have an allergy to hyaluronic acid, lidocaine or other local anaesthetics. Caution if you take medicines that prolong bleeding time. Treatment lasts 12-24 months. Restylane has not been tested in pregnant or breast-feeding women. ALWAYS FOLLOW THE INSTRUCTIONS YOU ARE GIVEN. Galderma, Auckland. Distributed by Healthcare Logistics, Auckland.

Reproduce verbatim. Do not modify or shorten.

Restylane® Skinboosters

Medical Device Class III
Short Consumer Mandatory Statement

Restylane® Skinboosters Medical Device Class III. For the treatment of skin structure, hydration and elasticity. Restylane Skinboosters has risks and benefits. Ask your doctor if Restylane Skinboosters is right for you. 20mg/ml stabilised hyaluronic acid. For product information check with your doctor or from product details with the supplier. Galderma Australia Sydney or distributor Healthcare Logistics, Auckland.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

Restylane® Skinboosters is a gel containing hyaluronic acid that is injected into or below the skin to improve skin structure, hydration and elasticity. Restylane® Skinboosters is a medical device class III that has risks and benefits. Do not use in patients with bleeding disorders, or in patients taking blood thinning medicines. Do not inject intravascularly, where there is active disease, inflammation, infection, or tumours near the intended treatment site. Possible side effects are injection site effects like swelling, bruising, and tenderness and inflammation. Treatment usually lasts 6-12 months. Product and treatment costs will apply. Consult your cosmetic practitioner for further information. Further product details can also be found in the full product information. Galderma, Auckland.

Reproduce verbatim. Do not modify or shorten.

S 4 entries

Sculptra®

Medical Device Class III
Short Consumer Mandatory Statement

Sculptra® Medical Device Class III to increase volume of depressed areas, particularly to correct skin depressions. Sculptra has risks and benefits. Contains Poly-L-Lactic acid implant suspension. Ask your doctor if Sculptra® is right for you. For product information check with your doctor or from product details with the supplier. Galderma Australia Sydney. Distributed by Healthcare Logistics, Auckland.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

Sculptra® is a poly-L-lactic acid implant liquid that is injected by a healthcare professional into or below the skin to increase volume of depressed areas, particularly to correct skin depressions. Class III Medical Device. Sculptra® may also be used for large volume restoration and/or correction of the signs of facial fat loss. Sculptra® has risks and benefits. Sculptra® treatment may result in injection site reactions and pain. Ask your healthcare professional to explain the range of possible side effects and tell them if any side effects concern you. Sculptra® should not be injected into skin that is inflamed or infected. Exposure to excessive sunlight or UV lamp exposure should be avoided until redness or swelling has resolved. Sculptra® is not recommended for people taking blood thinning medicines and has not been tested in pregnant or breast-feeding women or those aged under 18 years. Lasts for 12-25 months. ALWAYS FOLLOW THE INSTRUCTIONS YOU ARE GIVEN. Galderma Australia, Sydney. Distributed by Healthcare Logistics Auckland.

Reproduce verbatim. Do not modify or shorten.

STYLAGE®

Medical Device Class III
Consumer Mandatory Statement

STYLAGE® S Lidocaine (16mg/mL), STYLAGE® M Lidocaine™ (20mg/mL), STYLAGE® L Lidocaine™(24mg/mL), STYLAGE® XL Lidocaine™(26mg/mL), STYLAGE® XXL™(21mg/mL), and STYLAGE® Lips Plus are hyaluronic acid injectable gel classified as medical devices Class III for the filling of medium size and deep facial wrinkles by injection into the skin and for redefining lip and/or augmenting lip volume. Contains transparent cross-linked sodium hyaluronate gel of non-animal origin with lidocaine 0.3% to reduce the pain associated with the injection. Cautions: people with autoimmune disease, or who are pregnant, breastfeeding, under 18 years of age or have an increased susceptibility to keloid formation and hypertrophic scarring. People on blood thinning medicines. Possible side effects: injection site inflammatory reactions (redness/swelling, itching/pain on pressure) induration or nodules; discolouration. You will need to pay for this product and doctor's fees apply. If you have side effects or concerns speak to your practitioner. Distributed by EnVogue Skin NZ Pty Ltd. EnVogue Skin Pty Ltd. ABN 98 620 276 762. All brands and product names mentioned are trademarks of their respective holders. Copyright © 2023. All rights reserved.

Reproduce verbatim. Do not modify or shorten.

STYLAGE® Lips Plus

Medical Device Class III
Consumer Mandatory Statement

STYLAGE® Lips Plus (20mg/mL) IPN-Like Cross-linked Hyaluronic acid gel of non-animal origin with Mannitol and 0.3% Lidocaine is classified as medical devices Class III specially indicated for redefining lip and/or augmenting lip volume. Only to be administered by appropriately trained healthcare professionals who are qualified or accredited in accordance with national law. Always read and follow the instructions. If you have side effects or concerns speak to your practitioner. Distributed by EnVogue Skin NZ Pty Ltd. EnVogue Skin Pty Ltd. ABN 98 620 276 762. All brands and product names mentioned are trademarks of their respective holders. Copyright © 2023. All rights reserved.

Reproduce verbatim. Do not modify or shorten.

Sunekos®

Medical Device Class III
Short Consumer Mandatory Statement

Sunekos containing hyaluronic acid and amino acids is a class III medical device that modifies the structure of mature skin, restoring volume, filling wrinkles and folds in the skin and in scar sites. Sunekos has risks and benefits. Sunekos should not be used on patients: with known hypersensitivity to any of its components; presenting with a general infection, inflammation or irritation in the area to be treated; or in patients predisposed to coagulation disorders. A local reaction may rarely occur, caused by hypersensitisation phenomena, with symptoms that include oedema and sensation of burning and/or itching. These reactions normally resolve within two days. Consult your healthcare professional to see if Sunekos is right for you. For more information refer to the instructions for use. New Zealand Sponsor: AA-Med Pty Ltd. Distributed by: Xytide Biotech NZ Pty LTD.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

Sunekos 1200 is an implantable medical device that modifies the structure of mature skin, restoring volume, filling wrinkles and folds in the skin and in scar sites. It is suitable for creating a temporary increase in the volume of skin tissue. Sunekos 1200 is a medical device that is sterile, injectable, non-pyrogenic, biocompatible, re-absorbable, made with hyaluronic acid and amino acids. Sunekos Performa is a medical device recommended for the treatment of blemishes and depressions in the skin caused by wrinkles and scars. Sunekos Performa is a sterile resorbable injectable solution which acts as a filler, supporting the restoration of physiological elasticity and temporarily replacing volume by expanding the soft tissues. Sunekos should not be used on patients: with known hypersensitivity to any of its components; presenting with a general infection, inflammatory or infectious cutaneous problems; with history of severe multiple allergies or anaphylactic shock; prone to hypertrophic scars/keloids or streptococcal diseases; in patients presenting with porphyria; under 18 years of age; in pregnancy or lactation; others. See full Instructions for use before prescribing for full safety information, available from www.xytide.co.nz New Zealand Sponsor: AA-Med Pty Ltd Distributed by: Xytide Biotech NZ Pty Ltd (NZBN 9429049668612) C/O Alliott Ltd, Level 2, 142 Broadway, Newmarket, Auckland 1023 NZ. For more information please phone +61 1800 570 036.

Reproduce verbatim. Do not modify or shorten.

T 1 entry

Teosyal®

Medical Device Class III
Short Consumer Mandatory Statement

Teosyal® from Teoxane® Medical Device Class III is a space-occupying supplement to correct skin contour deformities (e.g. wrinkles, folds, scars especially around the eyes). Teosyal® has risks and benefits. Contains Hyaluronic Acid in various volumes with lidocaine 0.3% by mass. Ask your doctor if Teosyal® is right for you. For product information check with your doctor or from the supplier. Distributed by Healthcare Logistics Auckland.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

TEOSYAL RHA® 1, TEOSYAL RHA® 2, TEOSYAL RHA® 3, TEOSYAL RHA® 4, TEOSYAL® PURESENSE REDENSITY 1, TEOSYAL® PURESENSE REDENSITY 2, TEOSYAL PURESENSE KISS®, TEOSYAL® PURESENSE GLOBAL ACTION, TEOSYAL® PURESENSE DEEP LINES, TEOSYAL® PURESENSE ULTIMATE and TEOSYAL® PURESENSE ULTRA DEEP TEOSYAL KISS®, RHA KISS®, TEOSYAL® MESO, TEOSYAL® GLOBAL ACTION, TEOSYAL® DEEP LINES, TEOSYAL® ULTIMATE and TEOSYAL® ULTRA DEEP are trademarks of the firm TEOXANE SA. These products are gel that contains hyaluronic acid, and 0.3% by weight of lidocaine hydrochloride. They are class III medical devices. Caution for people on blood thinning medicines. Local side effects: inflammatory reactions (redness, oedema, pain at the point of injection), haematomas, itching, temporary loss of sensitivity around the injected area, disorders of pigmentation in skin and hair, abscesses, indurations, nodules (possibly granulomas). General manifestations: immediate hypersensitivity up to anaphylactic shock, migration of the implant. Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment or blindness, skin necrosis and stroke. Lasts 9-12 months. Please consult your doctor pharmacist for more information. Please refer to instructions for use, local distributor. Healthcare Logistics, Auckland.

Reproduce verbatim. Do not modify or shorten.

X 1 entry

Xeomin®

Prescription Medicine
Short Consumer Mandatory Statement

Xeomin® (incobotulinum toxin) Prescription Medicine for the treatment of upper facial lines: glabellar frown lines, crow's feet round the eyes, horizontal forehead lines. Xeomin® has risks and benefits. Ask your doctor if Xeomin® is right for you (incobotulinum toxin A, purified Botulinum toxin type A 50 Units and 100 Units). For product information check with your doctor or Consumer Medicine Information on www.medsafe.govt.nz. Merz, Sydney. Distributed by Healthcare Logistics, Auckland.

Reproduce verbatim. Do not modify or shorten.

Long Consumer Mandatory Statement

Xeomin® is a Prescription Medicine containing 50, 100 units of incobotulinum Type A, purified Botulinum toxin type A complex for injection. It is used for the treatment of frown lines on the forehead, lateral periorbital lines and horizontal forehead lines in adults. It should be administered only by trained medical professionals. Talk to your specialist about the benefits/risks of this procedure in appearance medicine. Xeomin® treatment lasts about four months and further courses of treatment may be necessary. Cautions: people receiving blood thinning medicines, care at the proposed injection sites, pregnancy and lactation. Possible side effects: headache, pain, swelling or infection at injection site, local muscle weakness including drooping eye lids, lack of feeling & nausea. Treatment last for up to 4 months. You will need to pay for this medicine. Discuss with your specialist if Xeomin® is right for you. For more information or for a copy of CMI please contact the NZ distributor: Merz, Sydney. Distributed by Healthcare Logistics, Auckland.

Reproduce verbatim. Do not modify or shorten.

Disclaimer

This page is general guidance, not legal advice. The information provided here is intended as general guidance for aesthetic practitioners in Aotearoa New Zealand. While MObyJC takes care to ensure the accuracy and currency of the content, advertising regulations evolve and consumer mandatory statements may be updated by manufacturers between our reviews. We do not accept responsibility for any errors, omissions, or outcomes resulting from reliance on this information.

Practitioners are advised to consult the official Medsafe and ASA guidelines, refer to the most recent versions of mandatory information supplied by their product distributors, and seek independent legal or pre-vetting advice (such as TAPS) before publishing any advertising or promotional material that involves prescription medicines or medical devices.

Built for our community

Bookmark this page. Share it with your team.

This page is here as a working reference for every aesthetic injector in Aotearoa. If you would like to talk to us about clinical oversight, training, or how we support independent practice, we are always available.