Category
Acne and rosacea medications, and what the FDA label actually says
7 medications9 FDA labels7 comparisons
Skin is the one category here where the same active ingredient routinely appears at three different levels: sold over the counter, prescribed as a stronger version, and approved for a completely different condition at a different dose. Adapalene and doxycycline are both examples on this page.
Every page in this category is built from the prescribing information or Drug Facts label filed with the FDA. Approved uses, strengths, directions, warnings and reported adverse reactions come from that document, and each page links to the exact label it was built from.
Nothing here is a recommendation. What suits a particular person's skin, if anything, is a question for that person and a clinician who can look at it.
FDA approvals and boxed warnings across this category
Built from the 9 labels linked on the pages below, so it cannot drift from them. A boxed warning is the strongest warning the FDA requires, and where several medications carry the same one, it belongs to the class rather than to the product.
| Medication | Class | Approved for skin | Boxed warning | Supply |
|---|---|---|---|---|
| TretinoinRetin-A Micro, Renova | Topical retinoid | Yes | None | Prescription |
| AdapaleneDifferin gel | Topical retinoid | Yes | None | Over the counter |
| Clindamycin phosphate and benzoyl peroxideClindamycin and benzoyl peroxide gel | Topical antibacterial combination | Yes | None | Prescription |
| IsotretinoinIsotretinoin capsules | Oral retinoid | Yes |
| Prescription |
| DoxycyclineOracea, Doryx MPC | Tetracycline-class antibacterial | Yes | None | Prescription |
| MetronidazoleMetronidazole topical gel | Topical antibacterial | Yes | None | Prescription |
| IvermectinSoolantra | Topical antiparasitic and anti-inflammatory | Yes | None | Prescription |
Two labels, side by side
- Retin-A MicrovsRenovaRetin-A Micro and Renova are both tretinoin, approved by the FDA for different things. What each label covers, and what the Renova label says it does not do.
- OraceavsDoryx MPCOracea is a 40 mg doxycycline approved for rosacea. Ordinary doxycycline is an antibiotic. What each FDA label covers, and what Oracea says it must not be used for.
- Retin-A MicrovsDifferin gelTretinoin and adapalene are both retinoids approved for acne, but one needs a prescription and the other does not. What each FDA label covers and how they are used.
- Metronidazole topical gelvsSoolantraTopical metronidazole and ivermectin are both approved for the inflammatory lesions of rosacea. What each FDA label covers and what neither of them explains.
- Isotretinoin capsulesvsRetin-A MicroBoth are forms of vitamin A approved for acne, one swallowed and one applied to the skin. The labels describe different severities, different courses and very different warnings.
- Clindamycin and benzoyl peroxide gelvsDifferin gelOne is a prescription gel containing an antibiotic, the other an over the counter retinoid. What each FDA label covers, including a contraindication that surprises people.
- OraceavsSoolantraBoth are approved for the inflammatory lesions of rosacea, one a capsule and one a cream. Neither label covers the redness. Compared straight from both documents.
Approved by the FDA for skin
Each of these has at least one FDA approval covering this use.
- TretinoinApproved for skin
Topical retinoid. Sold as Retin-A Micro, Renova.
Tretinoin is the original prescription retinoid, and it holds two separate FDA approvals for two different problems. Retin-A Micro is approved for acne. Renova, the same molecule at a lower strength in a different cream, is approved for fine facial wrinkles, and its label is unusually blunt about what it does not do.
- AdapaleneApproved for skinOver the counter
Topical retinoid. Sold as Differin gel.
Adapalene is the retinoid sold from the pharmacy shelf rather than behind the counter. Differin gel 0.1 percent carries a Drug Facts label, the format used for medicines sold without a prescription, rather than the prescribing information a clinician reads. That difference in document is the difference in how the product is sold.
- Clindamycin phosphate and benzoyl peroxideApproved for skin
Topical antibacterial combination. Sold as Clindamycin and benzoyl peroxide gel.
This is the prescription combination that pairs an antibiotic with benzoyl peroxide in one gel. The label records something worth knowing before starting any antibiotic for acne: resistance of the bacteria involved to clindamycin has been documented, and it often travels together with resistance to erythromycin.
- IsotretinoinApproved for skin
Oral retinoid. Sold as Isotretinoin capsules.
Isotretinoin is the only oral retinoid on this page and the only medication in this category with a boxed warning. That warning is about pregnancy: the label states that it must not be used by anyone who is pregnant or may become pregnant, because it causes severe birth defects.
- DoxycyclineApproved for skin
Tetracycline-class antibacterial. Sold as Oracea, Doryx MPC.
Doxycycline appears twice in the FDA register at two very different doses. Oracea is a 40 mg dose approved for the inflammatory lesions of rosacea, and its label instructs that it must not be used to treat bacterial infections or for antibacterial prophylaxis, because that use was never evaluated. The ordinary higher-dose doxycycline is approved as an antibiotic, which is a different medicine in practice.
- MetronidazoleApproved for skin
Topical antibacterial. Sold as Metronidazole topical gel.
Topical metronidazole is one of the two long-established prescription treatments for rosacea. It is the same molecule used as an oral antibiotic for infections, but the topical gel is a separate approval and is applied to the skin rather than swallowed.
- IvermectinApproved for skin
Topical antiparasitic and anti-inflammatory. Sold as Soolantra.
Soolantra is topical ivermectin, approved for the inflammatory lesions of rosacea. It is the same active ingredient as the oral antiparasitic medicine, formulated as a cream for the face and approved for a different purpose entirely.