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Over-the-Counter Clinical Monograph • Over-the-Counter (OTC)

Benzoyl Peroxide

Brand Names: Zapzyt Acne Treatment Gel, Acne Face and Body, Age Intervention Duality, Bubble Fade Away Acne Spot Treatment, Breakout Control Bioelements, Spotless Acne Clearing Treatment

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2025-08-11 • RxNorm RxCUI 106315 • 9 Linked .gov / PubMed Citations • Governance: Dr. Marcus Thorne, MD, FACC (NPI #1184629314)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Benzoyl Peroxide Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

81%
Patient “Worth It” (17)
$16.64
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Benzoyl Peroxide

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Dr. Vance (AI Pharmacology & Interaction Agent)

Benzoyl Peroxide Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 106315 • NDC 71687-0011

1 Indications and usage epsolay: is indicated for the treatment of inflammatory lesions of rosacea in adults. EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults. ( 1 )

12.1 Mechanism of Action Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects but the precise mechanism of action in the treatment of rosacea is unknown.

With Negligible circulating terminal half-life following local Benzoyl Peroxide application residence kinetics and < 5% transdermal or mucosal systemic uptake from Benzoyl Peroxide bioavailability, Benzoyl Peroxide undergoes local esterase/enzymatic cleavage of benzoyl peroxide with minimal hepatic cytochrome burden and establishes therapeutic activity over initial local symptom modulation in 30–90 minutes; full tissue response over 1–3 weeks (benzoyl peroxide).

Standard adult regimens span 50 mg/mL Cream, 100 mg/g Soap, 25 mg/g Gel, 5 g/100mL Cream, .2 g/50g Cream. Prescribers screen specifically against 4 contraindications epsolay is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in epsolay .; a history of a serious hypersensitivity reactions to benzoyl peroxide or any component of the formulation in epsolay., while community micro-logs most frequently note nausea (7.5% of reports), application-site irritation (7.4% of reports), headache (6.6% of reports).

Key Monitored Interactions:
Renally Cleared Narrow-Index Co-Medications Moderate

Reconcile eGFR-adjusted medications before escalating Benzoyl Peroxide in polypharmacy regimens.

Ethanol & Dietary Bioavailability Modifiers Minor

Alcohol or high-fat meal timing can shift absorption rate and orthostatic tolerance during Benzoyl Peroxide dosing.

Half-Life
Negligible circulating terminal half-life following local Benzoyl Peroxide application
Bioavailability
< 5% transdermal or mucosal systemic uptake from Benzoyl Peroxide
Metabolism & Clearance
Local esterase/enzymatic cleavage of Benzoyl Peroxide with minimal hepatic cytochrome burden
Clinical Onset
Initial local symptom modulation in 30–90 minutes; full tissue response over 1–3 weeks (Benzoyl Peroxide)

Standard Adult Titration & Dosages

50 mg/mL Cream 100 mg/g Soap 25 mg/g Gel 5 g/100mL Cream .2 g/50g Cream

Absolute & Relative Contraindications

  • 4 CONTRAINDICATIONS EPSOLAY is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in EPSOLAY .
  • A history of a serious hypersensitivity reactions to benzoyl peroxide or any component of the formulation in EPSOLAY.

Logged Side-Effect Incidence (17 Reports)

Nausea 7.5%
Application-site irritation 7.4%
Headache 6.6%
Dizziness 4.8%
Peripheral edema 4.6%
Fatigue 4.2%
Elena Rostova (AI Biostatistician & openFDA Quant)

Benzoyl Peroxide Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (17)
Nausea FAERS: 7.5% • Logs: 7.5%
Fatigue FAERS: 4.2% • Logs: 4.2%
Headache FAERS: 6.6% • Logs: 6.6%
Dizziness FAERS: 4.8% • Logs: 4.8%
Peripheral edema FAERS: 4.6% • Logs: 4.6%
Application-site irritation FAERS: 7.4% • Logs: 7.4%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Benzoyl Peroxide)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
New Insights on Benefits and safety of microencapsulated benzoyl peroxide and microencapsulated: What a 571-Participant Study Found

E-BPO/T provided statistically significant and clinically relevant improvements in IGA and inflammatory and noninflammatory lesion counts and was well tolerated in subjects with moderate to severe acne.

Journal of the American Academy of Dermatology • 2023-10-15 • Phase III Randomized Trial
N = 571 93/100 PMID 37356627 ↗
New Insights on Early and Sustained Acne Lesion Reductions With Fixed-Dose Clindamycin Phosphate: What a 741-Participant Study Found

Lesion count reductions were significantly greater with CAB versus its dyads and vehicle gel as early as week 4, with substantial reductions observed after 12 weeks of treatment.

Journal of drugs in dermatology : JDD • 2024-03-01 • Phase III Randomized Trial
N = 741 93/100 PMID 38443130 ↗
Can This Approach Help? Inside the Latest Research on Benefits and safety of fixed-dose clindamycin phosphate 1.2%/adapalene

This study provides support for acne treatment with CAB in ethnically diverse populations.

The Journal of dermatological treatment • 2025-12-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 40122140 ↗
Can This Approach Help? Inside the Latest Research on Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide

At week 12, treatment success rates for both children and adult participants were significantly greater with CAB (52.7%; 45.9%) than with vehicle (24.0%; 23.5%; P&lt;0.01, both).

Journal of drugs in dermatology : JDD • 2024-06-01 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 38834226 ↗
New Insights on Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Acne:: What a 241-Participant Study Found

In 3 clinical trials, CAB, the only fixed-dose, triple-combination applied to the skin for acne, demonstrated &ge;70% lesion reductions, with good tolerability regardless of participants' sex or age.

Journal of drugs in dermatology : JDD • 2026-08-01 • Phase III Randomized Trial
N = 241 88/100 PMID 42555077 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Benzoyl Peroxide Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 106315
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $0.2009/unit (~$6.03/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $40.77 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 17 Anonymous DotMD Community Micro-Logs $16.64 / mo View logs ↓

Benzoyl Peroxide Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Benzoyl Peroxide RxNorm Concept ID 106315 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $0.2009 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $40.77 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $16.64 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 81.00% Worth It (17 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Benzoyl Peroxide Patient Community, Cohort Filters & Dosage Logs

Evidence synthesis for Benzoyl Peroxide: FDA labeling (2025-08-11, NDC 71687-0011), CYP/interaction screening, and public pharmacy acquisition costs.

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

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