Acne Cleanser Cream
FDA Label NDC 49035-264

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walmart, Inc. for the product Acne Cleanser (NDC 49035-264). 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, stop use and ask a doctor if, keep out of reach of children., 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

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Other

→ Principal Display Panel

Active Ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Do Not Use If You

have very sensitive skin
are sensitive to benzoyl peroxide

When Using This Product

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.
avoid unnecessary sun exposure and use a sunscreen
avoid contact with the eyes, lips and mouth
avoid contact with hair and dyed fabrics, which may be bleached by this product
skin irritation may occur, characterized by redness, burning, itching, peeling or possible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration

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

wet face. Gently massage all over face for 20-30 seconds avoiding the eyes. 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 daily application to once a day or every other day
if going outside, apply sunscreen after using this product. If irritation or sensitivity develops stop use of both products and ask a doctor
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 above.

Other Information

keep tightly closed
store at room temperature (59⁰-77⁰F)

Inactive Ingredients

water, cetyl alcohol, petrolatum, acrylates/C10-30 alkyl acrylate crosspolymer, zinc lactate, steareth-2, glycerin, potassium cetyl phosphate, xanthan gum, benzyl alcohol, fragrance, disodium EDTA, laureth-4, BHT, sodium hydroxide, lactic acid, menthol

Other

Satisfaction guaranteed - For questions or comments please call 1-888-287-1915.

Distributed by : Wal-Mart Stores, Inc., Bentonville, AR 72716

*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Clean & Clear Continuous Control Acne Cleanser.

264.005/264AI Rev1