Label: WALGREENS MAXIMUM STRENGTH TINTED ACNE SPOT TREATMENT CREAM- benzoyl peroxide cream
- NDC Code(s): 0363-0256-51
- Packager: WALGREEN COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 26, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use if you
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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 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 doctor if
- Keep out of the reach of children.
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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.
- Inactive Ingredients
- Label
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INGREDIENTS AND APPEARANCE
WALGREENS MAXIMUM STRENGTH TINTED ACNE SPOT TREATMENT CREAM
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0256 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) WATER (UNII: 059QF0KO0R) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENTONITE (UNII: A3N5ZCN45C) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PEG-100 STEARATE (UNII: YD01N1999R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0256-51 1 in 1 CARTON 02/07/2020 1 18.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 02/07/2020 Labeler - WALGREEN COMPANY (008965063)