Benzoyl Peroxide Liquid
FDA Label NDC 35573-454

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Burel Pharmaceuticals, Llc for the product Benzoyl Peroxide (NDC 35573-454). 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 active ingredient, purpose, use, warnings:, do not use if you, when using this product, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Use

→ Warnings:

→ Do Not Use If You

→ When Using This Product

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel - 5% 5oz (148 G) Bottle Label

→ Principal Display Panel - 5% 8oz (237 G) Bottle Label

→ Principal Display Panel - 10% 5oz (148 G) Bottle Label

→ Prinicipal Display Panel - 10% 8oz (237 G) Bottle Label

Active Ingredient

benzoyl peroxide USP, 5% or 10%

Purpose

Acne medication

Use

For the treatment of acne

Warnings:

For external use only.

Avoid contact with eyes, eyelids, lips and mucous membranes.

Do Not Use If You

have very sensitive skin
are sensitive to benzoyl peroxide

When Using This Product

Avoid unnecessary sun exposure and use a sunscreen.
Avoid contact with eyes, lips, and mouth.
Avoid contact with hair or dyed fabrics, which may be bleached by this product.
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 a lower concentration.
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.
Stop use and ask a doctor if irritation becomes severe.

Keep Out Of Reach Of Children

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

Directions

SHAKE WELL.

Clean the skin thoroughly before applying this product.
Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs,follow the directions stated below.
One to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry.
Because excessive drying of the skin may occur, start with 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.
Follow directions in the sunscreen labeling.
If irritation or sensitivity develops stop use of both products and ask a doctor.

Other Information

Store at controlled room temperature, 15° - 30°C (59° - 86°F)

Inactive Ingredients

Carbomer interpolymer type A NF, cetyl alcohol NF, disodium oleamido MEA-sulfosuccinate, edetate disodium USP, glycerin USP, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate NF, propylene glycol USP, purified water USP, sodium coco-sulfate, sodium lauroamphoacetate, and xanthan gum NF.