Benzoyl Peroxide
PeroxidesFree Radical Scavenging ActivityDecreased Sebaceous Gland ActivityUS-FDASourced from openFDA
GET
/api/v1/drug/benzoyl-peroxideMechanism of action
Sourced from openFDAMechanism-of-action class: Free Radical Scavenging Activity.
Indications
Sourced from openFDA- Uses For the treatment and management of acne Penetrates pores to eliminate most acne and blemishes Helps prevent development of new acne blemishes and blackheadsICD-10: L70.0
Dosage & administration
Sourced from openFDADirections Pump a small amount of cleanser into dampened hands, and gently massage over face and neck using a circular motion. Rinse thoroughly with water and pat dry.
Warnings & precautions
Sourced from openFDAFor external use only When using this product Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Approval history
Sourced from openFDA- Oct 26, 1984NDANDA050557Valeant Intl
- Oct 23, 2008NDANDA050819Bausch
- Dec 8, 2008NDANDA022320Galderma Labs Lp
- Jul 15, 2015NDANDA207917Galderma Labs
- Jul 26, 2021NDANDA214902Mayne Pharma
- Apr 22, 2022NDANDA214510Mayne Pharma
- Oct 20, 2023NDANDA216632Bausch
- May 22, 2026NDANDA220736Galderma Laboratories, L.p
FDA shortages
Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.
- Clindamycin Phosphate; Benzoyl Peroxide, Gel, 25 mg/1 g; 10 mg/1 g (NDC 0591-3916-68)To be discontinuedSponsor: Teva Pharmaceuticals USA, Inc.Updated
FAERS reports
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
0 total reports matchedShare = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
- 1Drug Ineffective2,164—
- 2Dry Skin1,758—
- 3Acne1,671—
- 4Erythema1,487—
- 5Skin Burning Sensation1,216—
- 6Skin Irritation974—
- 7Skin Exfoliation719—
- 8Pruritus681—
- 9Inappropriate Schedule Of Product Administration670—
- 10Rash591—
- 11Overdose502—
- 12Pain Of Skin419—
- 13Hypersensitivity396—
- 14Swelling Face384—
- 15Condition Aggravated255—
Literature
Recent PubMed references pinned to Benzoyl Peroxide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Efficacy and Safety of Clascoterone Cream 1% and Clindamycin 1.2%/Benzoyl Peroxide 5% Gel Treatment in Patients With Acne.Journal of drugs in dermatology : JDD · 2026 · Kircik C, Kircik L, Squittieri N, et al.PMID 42235046DOI 10.36849/JDD.9745
- FRET-PET regulated semiconducting polymer dots for ultrasensitive and portable ratiometric detection of benzoyl peroxide.Journal of hazardous materials · 2026 · Pang Y, Cai Z, Ouyang Y, et al.PMID 42155936DOI 10.1016/j.jhazmat.2026.142413
- Treatment of Confluent and Reticulated Papillomatosis Using Fixed-Dose Clindamycin phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel.Journal of drugs in dermatology : JDD · 2026 · Yousefian F, Pattee J, Issa NT, et al.PMID 42081629DOI 10.36849/JDD.9769
- A smartphone-compatible AIE fluorescent probe for benzoyl peroxide detection and fingerprint imaging.Food chemistry · 2026 · Jia TT, Li JY, Zheng Y, et al.PMID 41825373DOI 10.1016/j.foodchem.2026.148831
- Combination Effects of Clindamycin and Benzoyl Peroxide Against Cutibacterium acnes.The Journal of dermatology · 2026 · Yoshihara K, Seyama S, Hayashi N, et al.PMID 41657327DOI 10.1111/1346-8138.70170
- Long-term efficacy and tolerability of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel for acne: pooled results from two 6-month studies.The Journal of dermatological treatment · 2026 · Draelos ZD, Baldwin H, Harper JC, et al.PMID 41552868DOI 10.1080/09546634.2026.2612873
- Microbial dysbiosis and foot odor in Nagashima-type palmoplantar keratosis: Improvement with topical benzoyl peroxide.The Journal of investigative dermatology · 2026 · Ono N, Ito Y, Aoki S, et al.PMID 41338335DOI 10.1016/j.jid.2025.11.011
- Smartphone-based digital image colorimetry for rapid benzoyl peroxide detection in wheat flour.Food chemistry · 2025 · Ibrahim HA, Fakhre NAPMID 41332027DOI 10.1016/j.foodchem.2025.146796
Clinical trials
The 10 most recently updated of 223 ClinicalTrials.gov registrations naming Benzoyl Peroxide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Occupational Cancer Screening in Firefighters: A Pilot Study Within the Inova Health SystemRecruiting · Interventional · 800 enrolled · Inova Health Care ServicesNCT06931561updated 2026-06-12
- Low-Dose Versus Conventional-Dose Oral Isotretinoin for Acne VulgarisNot yet recruiting · Phase 4 · Interventional · 164 enrolled · Pakistan Institute of Medical SciencesNCT07639073updated 2026-06-10
- Role of Akkermansia Muciniphila in Acne VulgarisNot yet recruiting · Early phase 1 · Interventional · 34 enrolled · Medical University of South CarolinaNCT06992154updated 2026-05-12
- Burn Pit Exposure in Veterans: A Cancer Screening Pilot Study at the Inova Saville Cancer Screening & Prevention CenterNot yet recruiting · Interventional · 100 enrolled · Inova Health Care ServicesNCT07485322updated 2026-04-21
- Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion SicknessActive not recruiting · Phase 3 · Interventional · 705 enrolled · Vanda PharmaceuticalsNCT06138613updated 2026-04-16
- Study to Assess Safety, Pharmacokinetics, and Treatment Effect of CabtreoNot yet recruiting · Phase 4 · Interventional · 100 enrolled · Bausch Health Americas, Inc.NCT07524946updated 2026-04-13
- Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne VulgarisActive not recruiting · Observational · 200 enrolled · Bausch Health Americas, Inc.NCT07205107updated 2026-04-01
- Topical 5% Spironolactone Gel Versus 0.1% Adapalene Gel for Acne Vulgaris: A Randomized Split-Face StudyNot yet recruiting · Phase 2 · Interventional · 40 enrolled · Assiut UniversityNCT07473895updated 2026-03-17
- Inova Cardiogenic Shock Registry (INOVA SHOCK)Recruiting · Observational · 3,000 enrolled · Inova Health Care ServicesNCT03378739updated 2026-03-16
- 1% Clascoterone Cream for the Treatment Acne VulgarisNot yet recruiting · Phase 3 · Interventional · 692 enrolled · Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.NCT07457294updated 2026-03-09
Frequently asked questions
- How does Benzoyl Peroxide work?
- Mechanism-of-action class: Free Radical Scavenging Activity.
- What is Benzoyl Peroxide used for?
- According to FDA labeling, Benzoyl Peroxide carries indications including: Uses For the treatment and management of acne Penetrates pores to eliminate most acne and blemishes Helps prevent development of new acne blemishes and blackheads. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Benzoyl Peroxide?
- Benzoyl Peroxide is classified as Peroxides, Free Radical Scavenging Activity, Decreased Sebaceous Gland Activity.
- What are the brand names for Benzoyl Peroxide?
- Benzoyl Peroxide is marketed under brand names including Acanya, Acne-Clear, Anti Bac, Benzac, Benzamycin, Benzefoam, Benzepro, Cabtreo.
Note. Data for
benzoyl-peroxide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.