The FDA states that Tri-Luma is currently the only FDA-approved drug containing hydroquinone, a prescription product approved for the short-term treatment of dark spots associated with moderate-to-severe melasma of the face. The FDA also states that over-the-counter (OTC) skin lightening products containing hydroquinone are deemed to be new drugs and are misbranded since enactment of the CARES Act. This guide reports those statements and what DailyMed shows for other listings.
What the FDA lists as approved
The Drugs@FDA record for NDA 021112 lists the brand name Tri-Luma for a prescription cream of fluocinolone acetonide, hydroquinone and tretinoin at 0.01%;4%;0.05%. The record is for that one product.
What the FDA says about OTC products
| Question | What the FDA states |
|---|---|
| Are OTC products containing hydroquinone approved? | The Skin Facts page says skin lightening products containing hydroquinone are not approved for over-the-counter sale. It adds that a prescription skin product containing hydroquinone can be obtained from a health care provider. |
| How are they treated since the CARES Act? | A drug safety communication says OTC skin lightening products containing hydroquinone are deemed to be new drugs and are misbranded. It says all OTC skin lightening products require an FDA approved new drug application before they can be legally marketed. |
| What changed on September 23, 2020? | The same communication says that, effective that date, manufacturers and distributors of OTC skin lightening products that do not have FDA approval must remove the products from the marketplace. |
| Are any OTC products legally marketed? | The FDA is alerting consumers there are no FDA-approved or otherwise legally marketed OTC skin lightening products. |
FDA advice, mercury findings and reports of skin problems
The FDA advises consumers not to use OTC skin lightening products due to high levels of mercury and/or hydroquinone. It also recommends that consumers talk to their doctor about treatment options for certain skin conditions including aged or dark spots.
The same page states that since 2019 its laboratory testing has found certain skin lightening products to contain high levels of mercury. It says applying them repeatedly can allow mercury to be absorbed into the bloodstream, potentially causing serious and potentially permanent health problems. That statement names mercury, not hydroquinone.
The FDA also says it has received reports of serious skin problems from people using skin-lightening products that contain hydroquinone. It lists skin rashes, swelling of the face and discoloration of the skin which may be permanent (ochronosis). The statement gives no strength. Reports like these cannot show cause and effect.
DailyMed listings and the European Union
A prescription hydroquinone 4% cream label on DailyMed shows the marketing status "unapproved drug other". Its disclaimer reads: "This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA."
A separate DailyMed listing for a hydroquinone 8% / tretinoin 0.025% emulsion shows the same marketing status and states that the drug has not been found by FDA to be safe and effective and that the labeling has not been approved by FDA.
A risk-benefit review article states that beginning in 2001 hydroquinone is no longer authorized for use in cosmetic skin lightening formulations in European Union countries.
What this does not tell you
These are regulatory statements and listings, not trial results. The OTC statements are about over-the-counter products, and this guide does not say how they apply to any prescription product. A DailyMed marketing status and disclaimer is reported here only as worded. The sources used here report no trial of hydroquinone 8% or of the blend with tretinoin, niacinamide and vitamin C, and no listing above is a trial. The European Union statement is a review article's description of cosmetic formulations. A licensed provider decides on treatment, and this guide gives no advice to start, stop or change a product.