Benzoyl peroxide

FDA label, SkinMedica Pharmaceuticals, Inc., effective 2010-05-12. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Contraindications

IV. CONTRAINDICATIONS NeoBenz® Micro, NeoBenz® Micro SD and NeoBenz® Micro Wash should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the products.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for benzoyl peroxide. Check the label's hepatic warnings.

Source: LiverTox, NIDDK

Pregnancy and lactation

Pregnancy

Pregnancy: Category C - Animal reproduction studies have not been conducted with benzoyl peroxide. It is also not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman only if clearly needed.

Lactation

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.

Breastfeeding (LactMed)

Topical 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.

Alternatives LactMed suggests considering:
Source: LactMed: Benzoyl Peroxide (NICHD, public domain)Revised Nov 15, 2024

Supply and cost

Drug shortage status

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Source: FDA Drug Shortages Database via openFDA

Recalls (last 24 months)

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Source: FDA Enforcement Reports via openFDAFDA recalls and safety alerts

Therapeutic equivalence (Orange Book)

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Source: FDA Orange Book data filesSearch the Orange Book

Price ladder

Not the price at the counter
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These are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.

VA Federal Supply ScheduleCMS NADACMedicare Part D plan filesMedicaid State Drug Utilization Data

Products and NDCs

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Recruiting clinical trials

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Source: ClinicalTrials.gov API (NLM)Search on ClinicalTrials.gov