Benzoyl Peroxide: uses, dosing, side effects & brands
Benzoyl Peroxide is a medicine sold in the U.S. under one brand, for acne vulgaris and rosacea. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Acne Vulgaris and Rosacea
- Available as
- Topical
- Sold as
- Epsolay
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- What the pharmacy pays
- about $0.05 per gm — not your price
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How benzoyl peroxide is dosed
From the FDA label for Epsolay (application NDA214510). Other benzoyl peroxide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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. Not for oral, ophthalmic, or intravaginal use. Discard unused EPSOLAY 60 days after first use. Apply to the affected areas once daily. ( 2 ) Wash hands after application. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )
Benzoyl Peroxide side effects
Most common adverse reactions (incidence ≥ 1%) are application site reactions: pain, erythema, pruritis and edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two randomized, double-blind, vehicle-controlled trials, adult subjects with rosacea applied EPSOLAY (N = 488) or vehicle (N = 234) once daily for 12 weeks. The majority of subjects were Caucasian (93%) and female (73%) with a mean age of 51 years. Table 1 presents the most common adverse reactions occurring in ≥ 1% of subjects treated with EPSOLAY and more frequently than in subjects treated with vehicle. Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with EPSOLAY and with Greater Frequency than Subjects Treated with Vehicle EPSOLAY N=488 Vehicle N=234 Application site pain 11 (2%) 2 (1%) Application site erythema 11 (2%) 2 (1%) Application site pruritus 6 (1%) 1 (<1%) Application site edema Application site edema includes: application site swelling and application site edema 4 (1%) 0 (0%) During the clinical trials,…
Who shouldn’t take benzoyl peroxide
EPSOLAY is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in EPSOLAY [ see Warnings and Precautions (5.1) ]. A history of a serious hypersensitivity reactions to benzoyl peroxide or any component of the formulation in EPSOLAY. ( 4 )
Every benzoyl peroxide product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Epsolay.
Combination products containing benzoyl peroxide
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Benzoyl Peroxide recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
SLMD Benzoyl Peroxide Acne Lotion
Chemical contamination: Presence of benzene
Owen Biosciences Inc. · Mar 3, 2026
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Pero…
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Private Label Skin Care Inc. · Sep 12, 2025
Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Private Label Skin Care Inc. · Sep 12, 2025
ARTISAN OF SKIN (Benzoyl Peroxide 10%)
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Private Label Skin Care Inc. · Sep 12, 2025
Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%)
Chemical contamination: Presence of benzene
Alchemee, LLC · Mar 12, 2025
How long benzoyl peroxide keeps
No benzoyl peroxide label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does benzoyl peroxide expire? The in-use limits and storage rules from its labelsBenzoyl Peroxide and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for benzoyl peroxide: levels in milk, effects in breastfed infants, and the drugs it would consider insteadTopical benzoyl peroxide has not been studied during breastfeeding. Because only about 5% is absorbed following topical application, it is considered a low risk to the nursing infant. Ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.
National Institute of Child Health and Human Development, record revised November 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about benzoyl peroxide
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,920 reports naming benzoyl peroxide, and the FDA flagged 54% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- erythema187 reports
- abortion spontaneous182 reports
- rash178 reports
- maternal exposure during pregnancy160 reports
- acne157 reports
- pruritus145 reports
- dry skin124 reports
- nausea112 reports
Read these as a signal, not a rate. A report does not mean benzoyl peroxide caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is benzoyl peroxide?
EPSOLAY (benzoyl peroxide) cream is for topical use. Each gram of EPSOLAY contains 50 mg of benzoyl peroxide.
Can you take benzoyl peroxide with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run benzoyl peroxide against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does benzoyl peroxide come in?
Across the brands we track, benzoyl peroxide is currently marketed as topical, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic benzoyl peroxide?
We do not currently list a generic-labelled benzoyl peroxide product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has benzoyl peroxide been recalled?
The FDA's Enforcement database lists at least 5 recall records whose product description mentions benzoyl peroxide. The most recent: SLMD Benzoyl Peroxide Acne Lotion (Mar 3, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Benzoyl Peroxide: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/benzoyl-peroxide
- MLA
- “Benzoyl Peroxide: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/benzoyl-peroxide.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for benzoyl peroxide on DailyMed (NIH) ↗.