Benzoyl Peroxide 10% Topical Wash Liquid
FDA Label NDC 82461-313

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medcore Llc for the product Benzoyl Peroxide 10% Topical Wash (NDC 82461-313). 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 drug facts, active ingredient, purpose, uses, warnings, instructions for use, keep out of the reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Instructions For Use

→ Keep Out Of The Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel - 5% 5 Oz Bottle Label

→ Principal Display Panel - 5% 8 Oz Bottle Label

→ Principal Display Panel - 10% 5 Oz Bottle Label

→ Principal Display Panel - 10% 8 Oz Bottle Label

Drug Facts

Active Ingredient

BENZOYL PEROXIDE 5% or 10%

Purpose

Acne medication

Uses

For the treatment of acne

Warnings

For external use ONLY. Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. Avoid unnessary sun exposure and use a sunscreen. Avoid contact with eyes, lips and mouth. Avoid contact with hair,dyed fabrics, which may be bleached by thisproduct. Skin irritation may occur characterized by redness, burning, itching, peeling or possibly swelling, Irritation may be reduced by using the product less frequently or in lower concentration.If irritation or sensitivy develops stop use of both products and ask a doctor.

Instructions For Use

Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside, apply sunscreen after using this product

Keep Out Of The Reach Of Children.

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

Directions

adults and children 2 years and older	apply externally to the affected area up to 3 to 4 times a day
children under 2 years	ask a doctor

Other Information

Store at room temperature 15°-30°C(59°-86°F) Avoid storing product in direct sunlight and protect product from excessive moisture.

Inactive Ingredients

CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) cetyl alcohol edetate disodium glycerinGLYCERYL STEARATE/PEG-100 STEARATE laureth-12 magnesium aluminum silicate propylene glycol sodium lauroamphoacetate sodium coco-sulfate xanthan gum Water PHENOXYETHANOL