Category
Acne and rosacea medications, and what the FDA label actually says
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.
- Medications
- 12
- FDA approved for this
- 12
- FDA labels read
- 14
- Comparisons
- 11
- Carry a boxed warning
- 1
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.
- WinlevivsAldactoneWinlevi (clascoterone) is FDA-approved for acne; spironolactone is not - its label covers heart failure and hypertension. The two documents, read honestly.
- AkliefvsDifferin gelAklief (trifarotene) is a prescription retinoid approved from age 9; Differin (adapalene 0.1%) is sold over the counter. The two retinoid documents compared.
- CabtreovsClindamycin and benzoyl peroxide gelCabtreo adds adapalene to the clindamycin and benzoyl peroxide pair. One ingredient apart, generic against brand - the two combination labels compared.
- RhofadevsSoolantraRhofade (oxymetazoline) is approved for the persistent redness of rosacea; Soolantra (ivermectin) for its inflammatory lesions. Two labels, two problems - compared.
FDA approvals and boxed warnings across this category
Built from the 14 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 | ClassTopical retinoid | Approved for skinYes | Boxed warningNone | SupplyPrescription |
| AdapaleneDifferin gel | ClassTopical retinoid | Approved for skinYes | Boxed warningNone | SupplyOver the counter |
| Clindamycin phosphate and benzoyl peroxideClindamycin and benzoyl peroxide gel | ClassTopical antibacterial combination | Approved for skinYes | Boxed warningNone | SupplyPrescription |
| IsotretinoinIsotretinoin capsules | ClassOral retinoid | Approved for skinYes | Boxed warning
| SupplyPrescription |
| DoxycyclineOracea, Doryx MPC | ClassTetracycline-class antibacterial | Approved for skinYes | Boxed warningNone | SupplyPrescription |
| MetronidazoleMetronidazole topical gel | ClassTopical antibacterial | Approved for skinYes | Boxed warningNone | SupplyPrescription |
| IvermectinSoolantra | ClassTopical antiparasitic and anti-inflammatory | Approved for skinYes | Boxed warningNone | SupplyPrescription |
| ClascoteroneWinlevi | ClassAndrogen receptor inhibitor | Approved for skinYes | Boxed warningNone | SupplyPrescription |
| TrifaroteneAklief | ClassRetinoid | Approved for skinYes | Boxed warningNone | SupplyPrescription |
| Clindamycin, adapalene and benzoyl peroxideCabtreo | ClassAntibacterial, retinoid and oxidizing agent, fixed combination | Approved for skinYes | Boxed warningNone | SupplyPrescription |
| Benzoyl peroxideEpsolay | ClassOxidizing agent | Approved for skinYes | Boxed warningNone | SupplyPrescription |
| OxymetazolineRhofade | ClassAlpha-adrenergic agonist | Approved for skinYes | Boxed warningNone | SupplyPrescription |
Approved by the FDA for skin
Each of these has at least one FDA approval covering this use.
- Tretinoin
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.
- AdapaleneOver 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 peroxide
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.
- Isotretinoin
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.
- Doxycycline
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.
- Metronidazole
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.
- Ivermectin
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.
- Clascoterone
Androgen receptor inhibitor. Sold as Winlevi.
Clascoterone is sold as Winlevi and stands alone in this category by mechanism: it is a topical androgen receptor inhibitor, approved for acne in patients 12 years of age and older. Every other acne medication on these pages works through retinoid receptors, bacteria or keratin - this one addresses androgen signaling in the skin.
- Trifarotene
Retinoid. Sold as Aklief.
Trifarotene is sold as Aklief and is the newest retinoid on these pages, with two distinctions written into its label: approval from 9 years of age - the youngest in this category - and dosing instructions that cover the trunk, not only the face.
- Clindamycin, adapalene and benzoyl peroxide
Antibacterial, retinoid and oxidizing agent, fixed combination. Sold as Cabtreo.
Sold as Cabtreo, this is the only triple-combination acne product on these pages: a lincosamide antibacterial, a retinoid and benzoyl peroxide in one gel, approved for acne in patients 12 years of age and older. Each of its three components also exists on this site separately or in two-ingredient combinations.
- Benzoyl peroxide
Oxidizing agent. Sold as Epsolay.
Benzoyl peroxide is everywhere in acne care, yet the page you are reading is built from the one place it has a single, linkable FDA document: Epsolay, a prescription cream approved for the inflammatory lesions of rosacea in adults. The familiar acne washes and gels are sold under an over-the-counter monograph - rules for a whole class of products, with no single label to cite.
- Oxymetazoline
Alpha-adrenergic agonist. Sold as Rhofade.
Oxymetazoline cream, sold as Rhofade, addresses the one part of rosacea the other medications here do not: the persistent facial redness. Soolantra and Epsolay are approved for the inflammatory bumps of rosacea; this label is about erythema, and the two problems are treated by different documents.