SkinActive ingredient
Benzoyl peroxide
Oxidizing agent1 FDA label read
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.
Highlights of the labels
- Epsolay
- Inflammatory lesions of rosaceacovers skin
- Supply
- Prescription only
- Generic
- 25 approved applications
- Boxed warning
- None in these labels
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| EpsolayMayne Pharma Commercial LLC | What its label approvesInflammatory lesions of rosaceaCovers skin | SupplyPrescription | Label version11 August 2025 |
How it works
The Epsolay label describes benzoyl peroxide as an oxidizing agent with bactericidal and keratolytic effects, and states that the precise mechanism of action in the treatment of rosacea is unknown. The cream is applied once daily in a pea-sized amount per area of the face.
Mechanism of action, Epsolay label
Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects but the precise mechanism of action in the treatment of rosacea is unknown.
What the FDA approved it for
The approved uses, as worded in the label.
EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults.
Forms and strengths
The presentations and strengths listed in the label.
Each gram of EPSOLAY contains 50 mg of benzoyl peroxide in a white to off-white base.
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
- Before initial use, prime the pump until the first drop of cream is released.
- Apply a pea-sized amount of EPSOLAY once daily in a thin layer to each area of the face (forehead, chin, nose, each cheek) on clean and dry skin.
- Avoid the eyes, lips and mouth.
- Wash hands after application.
- EPSOLAY may bleach hair or colored fabric.
- EPSOLAY is for topical use only.
Most common adverse reactions
The adverse reactions the label reports as most common.
- Most common adverse reactions (incidence ≥ 1%) are application site reactions: pain, erythema, pruritis and edema.
- most common adverse reactions occurring in ≥ 1% of subjects treated with EPSOLAY and more frequently than in subjects treated with vehicle.
Warnings and precautions
The warnings and precautions section of the label.
- Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with the use of benzoyl peroxide products.
- Skin irritation/contact dermatitis: Erythema, scaling, dryness, stinging/burning, irritation and allergic contact dermatitis may occur with use of EPSOLAY and may necessitate discontinuation.
- Photosensitivity: Avoid or minimize exposure to natural or artificial sunlight and use sun protection measures.
Contraindications
Situations in which the label states the medication must not be used.
EPSOLAY is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in EPSOLAY.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
The systemic exposure of benzoyl peroxide is unknown. Based on the published literature, benzoyl peroxide is metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine. Hence, maternal use is not expected to result in fetal exposure to the drug.
Generic or brand
The register lists 25 approved generic applications for benzoyl peroxide as an ingredient across prescription products. The over-the-counter acne products are a separate world: they are marketed under the OTC monograph rather than through individual approved applications.
The FDA label database lists 25 approved generic applications for this ingredient.
What affects the cost
The CMS pricing set lists no acquisition figures for the prescription cream yet. Over-the-counter benzoyl peroxide washes and gels are priced as consumer goods and sit outside this data in any case. This site sells nothing and links to no sellers.
Common questions
- Is this the same benzoyl peroxide as in acne washes?
- The ingredient is the same; the products and their regulatory paths are not. Epsolay is a prescription cream with its own FDA-approved label, for rosacea. The acne washes and gels are sold under the over-the-counter monograph, a set of rules for the category rather than a document for one product, which is why they have no label to link to here.
- What is Epsolay approved for?
- The treatment of inflammatory lesions of rosacea in adults. Acne does not appear in its label.
- What does the Epsolay label warn about?
- Severe hypersensitivity reactions including anaphylaxis and angioedema, skin irritation and contact dermatitis, and photosensitivity, with sun protection advised. The wording is quoted on this page.
Other medications under skin
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Epsolay
Mayne Pharma Commercial LLC. Label version 2, effective 11 August 2025.
Each stripe is one section of the label, each division in a stripe one entry in that section.
Page last updated 29 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.