Benzoyl Peroxide
FDA Label NDC 66078-033

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Md Formulation for the product Benzoyl Peroxide (NDC 66078-033). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Benzoyl Peroxide 10%

Otc - Purpose

Acne Treatment

Indications & Usage

Treats and helps prevent acne pimples.

Warnings

Foe external use only

Otc - Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1 to 3 times dally. Because excessive drying of the skin may accur, start with 1 application daily, then gradually increase to 2 to 3 times daily If needed or as directed by aphysician. If bothersome dryness or peeling occurs, reduce application to once a day or every other other day.

Inactive Ingredient

Inactive Ingredients:Water, glycerin, propylene glycol, carbomer, diazolidinyl urea, methylparaben, propylparaben, aminomethyl propanol.

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