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Drug Facts
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Walgreens Maximum Strength Acne Treatment Gel
FDA Label NDC 0363-8798
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Walgreens Maximum Strength Acne Treatment (NDC 0363-8798). 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 other, active ingredient, purpose, use, warnings, do not use if you, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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⬩ are sensitive to benzoyl peroxide
When Using This Product
⬩ 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 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⬩ 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.
Stop Use And Ask A Doctor If
⬩ irritation becomes severe.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Directions
⬩ 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, start with one application daily, then gradually increase to two to 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. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Other Information
⬩ keep tightly closed⬩ store at room temperature
Inactive Ingredients
bentonite, carbomer, ethylhexylglycerin, glyceryl stearate, isopropyl myristate, PEG-12 dimethicone, phenoxyethanol, potassium hydroxide, propylene glycol, water.
Questions Or Comments?
1-800-925-4733
Principal Display Panel - 28 G Tube Carton
MAXIMUM STRENGTH
Acne Treatment Gel
10% BENZOYL PEROXIDE / ACNE MEDICATION
NET WT 1 OZ (28 g)
Principal Display Panel (28 g Tube Carton)
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