Melasma pages are some of the hardest-working pages on a dermatology or med spa site. Searches like “melasma treatment near me” and “how to get rid of dark spots on face” come from people who have often tried store creams for months. Clinics answer with “erase melasma for good,” “laser that removes pigment in one session” and a shop page full of brightening serums. Those three lines raise three different sets of rules: FTC rules on health claims, FDA rules on skin lightening drugs, and the plain fact that melasma tends to come back.
This guide is for dermatologists, med spas, aesthetic nurses and laser clinics that treat melasma and other hyperpigmentation. It covers how to describe the condition, what recent reviews say about lasers, peels and other procedures, what changed for hydroquinone and other skin lighteners in 2020, mercury products patients may bring in, and photos, reviews and package prices. We do not name any drug, device, brand or company. For general dermatology marketing, see our guide to dermatology practice marketing, and for peel claims in detail, our guide to chemical peel advertising rules.
This is general information, not legal or medical advice. Sources cited were checked on November 1, 2026: the FDA Drug Safety Communication on OTC skin lightening products (April 19, 2022, content current as of May 1, 2026); FDA’s health fraud page on skin products containing mercury and/or hydroquinone and its consumer update on mercury poisoning linked to skin products; FDA drug labels for the approved prescription triple-combination melasma cream (label version October 24, 2024) and for oral tranexamic acid tablets (label version September 29, 2025) through openFDA; the PubMed abstracts of four 2025 and 2026 systematic reviews of melasma treatments; 21 CFR 700.13, 201.128, 878.4810, 807.97, 16 CFR 233.1, 255.2 and 255.5 in the eCFR version as of October 29, 2026; FDA device classification and 510(k) data through openFDA (queried November 1, 2026); 15 USC 45 and 52 in the Cornell LII text of the U.S. Code; and the FTC Health Products Compliance Guidance (December 2022). We did not review any state law on who may perform laser or peel procedures. Check your state board’s rules before you advertise who does the treatment.
The short version
- Do not promise a cure. Recent reviews describe melasma as a chronic condition, and they report recurrence after treatment. “Can lighten melasma; maintenance and sun protection are part of the plan” fits the evidence. “Gone for good” does not.
- Lasers are not a shortcut past creams. A 2026 meta-analysis of randomized trials found a triple-combination cream reduced melasma scores more than a picosecond laser, and found more post-inflammatory hyperpigmentation with the laser than with topical creams.
- No OTC skin lightener is legal. FDA says that since September 23, 2020, OTC skin lightening products need an approved new drug application, and that there are no FDA-approved or otherwise legally marketed OTC skin lightening products.
- Product claims make a drug. A serum sold in your shop with “fades melasma” or “lightens dark spots” can be an unapproved drug, whatever is in it. Intended use is judged from the label, the website and other labeling (21 CFR 201.128).
- Off-label means off-label. Oral tranexamic acid tablets are FDA-approved for heavy menstrual bleeding, not melasma. Do not call a melasma pill or injection “FDA-approved for melasma.”
Describing melasma accurately
The reviews we read describe melasma as a chronic, acquired hyperpigmentation disorder that mainly affects sun-exposed areas of the face and neck, and that affects women and people with darker skin types more often. The FDA-approved prescription triple-combination cream for melasma is labeled for use together with sun avoidance measures, including sunscreen. Points that follow for your pages:
- Say melasma is common and treatable, and that it tends to return. That is the honest frame, and it sets up a maintenance plan instead of a single package.
- Do not diagnose from photos. Dark patches on the face can be melasma, sun spots, post-inflammatory hyperpigmentation or something that needs a closer look. A photo upload form can invite a consult; its reply should not say “you have melasma.” Our guide to online patient intake forms covers how to collect photos and history safely.
- If your page discusses pregnancy, keep it general and point people to their own clinician. The triple-combination cream label contains a teratogen warning for its tretinoin ingredient, so “safe during pregnancy” claims for that class of product are wrong.
- Avoid copy that frames darker skin as a problem to be fixed. Describe the condition you treat, not a skin tone. FDA’s consumer update notes that illegal mercury lightening creams are often sold in shops catering to particular communities.
Laser, light and energy device claims
Lasers used on skin are generally regulated as powered laser surgical instruments, a Class II device type under 21 CFR 878.4810 (product code GEX), with 2,890 510(k) records in openFDA as of November 1, 2026. Each cleared device has its own Indications for Use. A device being cleared says nothing about melasma unless its indications name it, and under 21 CFR 807.97 you may not imply that a 510(k) clearance is FDA approval.
What recent reviews say:
- A 2026 meta-analysis of 5 randomized trials with 139 patients compared a 755-nm picosecond laser with other treatments. A triple-combination cream reduced melasma scores more than the laser, and post-inflammatory hyperpigmentation was more common with the laser than with topical creams. The authors rate overall certainty as low.
- A 2026 meta-analysis of 31 studies with 2,801 patients found that combining a Q-switched laser with intense pulsed light lowered severity scores more than either alone, with a lower recurrence rate. It found no difference in patient satisfaction, and its authors say longer studies are needed.
In practice:
- “Our laser removes melasma” or “one-session pigment removal” is a health claim that needs competent and reliable scientific evidence for that device, setting and number of sessions (FTC Health Products Compliance Guidance). The reviews above do not support it.
- Mention post-inflammatory hyperpigmentation as a risk. The picosecond review found it more often with the laser than with creams. A page that says “safe for all skin types” with no qualifier invites trouble.
- Do not borrow a pooled figure, such as an efficacy rate from a meta-analysis, and present it as your clinic’s result. If you publish your own outcomes, say how many patients, how improvement was measured and over what period.
- “The most advanced melasma laser” or “better than peels” is a comparative claim. It needs head-to-head evidence, and the 2026 review found the opposite result for one laser against cream.
Peels, microneedling, injections and PRP
- Peels. A claim that a peel series “removes melasma” needs evidence for that peel, strength and schedule. Our chemical peel guide covers service ads and take-home peel products.
- Tranexamic acid injections and microneedling. A 2026 systematic review of intradermal tranexamic acid reported improvement in melasma severity, with mild and transient side effects, across studies of different concentrations. A 2026 meta-analysis of 8 studies with 232 patients found no significant difference between microneedling with tranexamic acid and microneedling with vitamin C, with follow-up of 6 to 16 weeks, and says long-term safety and recurrence cannot be judged from that evidence.
- Oral tranexamic acid. The tablet label’s approved use is cyclic heavy menstrual bleeding. It is contraindicated with combined hormonal contraception and in people with active blood clots or a history or intrinsic risk of thrombosis. If you offer it for melasma, say it is off-label use decided by a prescriber after screening, and never sell it as a “melasma pill.”
- PRP. A 2026 meta-analysis of 11 studies found no significant overall difference in melasma severity between platelet-rich plasma and comparison treatments. “PRP for melasma” can be offered, but not as a proven upgrade.
- Microneedling generally. Our guide to microneedling clinic marketing covers device and result claims for needling.
Hydroquinone and skin lightening products
This is the area where clinics most often get caught by a change they missed. FDA’s Drug Safety Communication of April 19, 2022 explains:
- The CARES Act of 2020 reformed OTC drug rules and finalized the status of OTC skin lightening products. OTC skin lightening products containing hydroquinone are deemed new drugs and are misbranded.
- All OTC skin lightening products require an FDA-approved new drug application. Effective September 23, 2020, sellers of unapproved OTC skin lightening products had to remove them from the market.
- In April 2022 FDA issued warning letters to 12 companies for selling OTC hydroquinone products, and it says there are no FDA-approved or otherwise legally marketed OTC skin lightening products.
- FDA has received reports of skin rashes, facial swelling and ochronosis, a skin discoloration that may be permanent, from skin lightening products containing hydroquinone. It says many of its concerns about hydroquinone in OTC drugs also apply to hydroquinone in cosmetics.
- FDA names one approved hydroquinone drug: a prescription triple-combination cream for short-term treatment of moderate to severe melasma of the face. Its label says it is not indicated for maintenance treatment.
What that means for a practice:
- Do not sell a hydroquinone cream over the counter in your waiting room or online shop. Prescribing a drug to a patient is a different path from retail sale, and how you dispense or compound it brings its own rules.
- A non-hydroquinone “brightening” serum is still a drug if you sell it with claims to fade melasma, lighten dark spots or reduce melanin (21 CFR 201.128 on intended use). Keep retail copy to appearance language and keep treatment claims for your services. Our guide to private label supplements and skincare covers shop pages in more detail.
- If you describe the approved prescription cream, keep to its label: short-term, moderate to severe facial melasma, with sun protection, not for maintenance, and with its warnings, including possible ochronosis.
Mercury creams patients may bring in
FDA says that since 2019 its laboratory testing has found high levels of mercury in certain skin lightening products, and that repeated use can cause kidney and nerve damage. Children and pregnant people face higher risks. 21 CFR 700.13 says there is no justification for mercury in skin bleaching preparations and that its effectiveness as a skin bleaching agent is questionable. FDA’s consumer update says these products are often made abroad, sold illegally, promoted on social media and labeled with words such as “mercurous chloride,” “calomel,” “mercuric,” “mercurio” or “mercury.”
- A patient education page on unsafe lightening creams is useful and accurate content. Link to FDA’s pages and its list of tested products; do not name or shame a product yourself.
- For a patient who may have used such a product, point them to their clinician or the Poison Help line listed on FDA’s page.
- Do not use fear of these products to sell your own retail line as the safe alternative unless that line has no drug claims and you can support what you say about it.
Before-and-after photos, reviews and prices
- Photos. Use the same light, angle, camera settings and no makeup in both images, and say how many sessions and how long after the last one the photo was taken. A result shown right after a series, when melasma may return later, gives a misleading net impression if you present it as permanent (15 USC 45).
- Reviews and testimonials. A review that says “my melasma never came back” is a claim you are making when you feature it. Under 16 CFR 255.2, featuring an endorsement means you need evidence for what it implies, and results that are not typical need a clear statement of what people can generally expect. Disclose any discount or free treatment given for a review (16 CFR 255.5).
- Packages. If your melasma plan needs ongoing maintenance, say so on the price page. A “was $1,500, now $900” claim needs a real former price you actually charged for a reasonable time (16 CFR 233.1).
- Seasonal offers. “Summer melasma special” is fine as a label. Say what sun protection the plan requires, since the approved cream is labeled for use with sun avoidance.
How we help
We build sites and campaigns for dermatology and aesthetic practices, with claims checked against the sources above: website design with condition pages that explain evaluation and maintenance, healthcare SEO for searches like “melasma treatment near me,” and lead generation with consult forms that do not diagnose. Practices that treat other pigment conditions should also read our guide to vitiligo treatment advertising. We do not give legal or clinical opinions and we are not a law firm.
Can we say our treatment cures melasma?
No. Recent systematic reviews describe melasma as chronic and report recurrence after treatment. Say treatment can lighten melasma and that maintenance and sun protection are part of the plan.
Can we sell hydroquinone cream in our office shop?
Not as an over-the-counter product. FDA says that since September 23, 2020, OTC skin lightening products need an approved new drug application, and that there are no FDA-approved or otherwise legally marketed OTC skin lightening products. Prescription use is a separate path with its own rules.
Can our brightening serum say it fades melasma?
That wording makes it a drug claim. Under 21 CFR 201.128, intended use is judged from the label, website and other labeling, so a product sold to fade melasma or lighten dark spots can be an unapproved drug. Keep retail copy to appearance language.
Is laser the best treatment for melasma?
Not on current evidence. A 2026 meta-analysis of randomized trials found a triple-combination cream reduced melasma scores more than a picosecond laser, with more post-inflammatory hyperpigmentation in the laser group. Avoid “best” or “better than creams” claims.
Can we advertise tranexamic acid for melasma?
You can say a prescriber may offer it, but not that it is FDA-approved for melasma. Oral tranexamic acid tablets are approved for cyclic heavy menstrual bleeding and carry contraindications related to blood clots and combined hormonal contraception.
Can we post before-and-after photos of melasma patients?
Yes, with written patient permission, matched lighting and angle, no makeup, and the number of sessions and time since treatment stated. Do not present a short-term result as permanent, since melasma can return.
Sources
- FDA: FDA works to protect consumers from potentially harmful OTC skin lightening products (April 19, 2022)
- FDA: Skin products containing mercury and/or hydroquinone
- FDA consumer update: Mercury poisoning linked to skin products
- Picosecond alexandrite lasers in melasma: systematic review and meta-analysis of RCTs (Australasian Journal of Dermatology, 2026), PubMed
- Q-switched laser combined with intense pulsed light in melasma: a meta-analysis (Frontiers in Medicine, 2026), PubMed
- Intradermal tranexamic acid and melasma: a systematic review (Italian Journal of Dermatology and Venereology, 2026), PubMed
- Microneedling with tranexamic acid versus vitamin C in melasma: systematic review and meta-analysis (Journal of Medicine and Life, 2026), PubMed
- Platelet-rich plasma in melasma: systematic review and meta-analysis (Aesthetic Plastic Surgery, 2026), PubMed
- 21 CFR 700.13: Use of mercury compounds in cosmetics
- 21 CFR 201.128: Meaning of intended uses
- 21 CFR 878.4810: Laser surgical instrument
- 21 CFR 807.97: Misbranding by reference to premarket notification
- FTC: Health Products Compliance Guidance (December 2022)
- 16 CFR 233.1: Former price comparisons
- 16 CFR 255.2: Consumer endorsements
- 16 CFR 255.5: Disclosure of material connections
- 15 USC 45: Unfair methods of competition unlawful
- 15 USC 52: Dissemination of false advertisements
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