Label: OXY SENSITIVE SKIN ACNE CREAM CLEANSER- benzoyl peroxide 5% cream
- NDC Code(s): 10742-1004-1
- Packager: The Mentholatum Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 5, 2024
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
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 possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
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Directions
- wet face
- apply to hands then massage gently into face. If desired, leave on for 1-2 minutes.
- rinse thoroughly and pat dry
- follow with a non-comedogenic moisturizer if needed
- because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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
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Inactive ingredients
water, cetostearyl alcohol, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, capryl/capramidopropyl betaine, xanthan gum, butylene glycol, chlorphenesin, citric acid, glycerin, hydrolyzed soy protein, PEG-8 dimethicone, phenoxyethanol, portulaca oleracea extract, propanediol, rhodomyrtus tomentosa fruit extract, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate
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INGREDIENTS AND APPEARANCE
OXY SENSITIVE SKIN ACNE CREAM CLEANSER
benzoyl peroxide 5% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-1004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E) XANTHAN GUM (UNII: TTV12P4NEE) RHODOMYRTUS TOMENTOSA FRUIT (UNII: Q99511S58K) SODIUM HYDROXIDE (UNII: 55X04QC32I) GLYCERIN (UNII: PDC6A3C0OX) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) WATER (UNII: 059QF0KO0R) CITRIC ACID (UNII: 2968PHW8QP) CHLORPHENESIN (UNII: I670DAL4SZ) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) PEG-8 DIMETHICONE (UNII: GIA7T764OD) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM CITRATE (UNII: 1Q73Q2JULR) PORTULACA OLERACEA LEAF (UNII: 9JW9D9JGHZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-1004-1 148 mL in 1 TUBE; Type 0: Not a Combination Product 08/15/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 08/15/2024 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 manufacture(10742-1004)
