Label: OXY 10 ACNE CLEANSER- benzoyl peroxide cream
- NDC Code(s): 10742-1397-1, 10742-1397-2
- Packager: The Mentholatum Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 13, 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 this product less frequently or in a lower concentration.
- Keep Out of Reach of Children
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Directions
- wet face
- apply to hands then work into a lather and massage gently onto face
- rinse thoroughly and pat dry
- because excessive drying of the skin may occur, start with 1 use 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 usage 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: Apply product sparingly to a small affected area for the first 3 days. If no discomfort occurs, follow directions above.
- 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, citric acid, diazolidinyl urea, fragrance, hydrolyzed soy protein, hydroxyphenyl propamidobenzoic acid, methylparaben, PEG-8 dimethicone, pentylene glycol, propylparaben, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate
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INGREDIENTS AND APPEARANCE
OXY 10 ACNE CLEANSER
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-1397 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 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E) CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) SOY PROTEIN (UNII: R44IWB3RN5) HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-8 DIMETHICONE (UNII: GIA7T764OD) PENTYLENE GLYCOL (UNII: 50C1307PZG) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-1397-1 148 mL in 1 TUBE; Type 0: Not a Combination Product 07/01/2018 2 NDC:10742-1397-2 185 mL in 1 TUBE; Type 0: Not a Combination Product 07/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 07/01/2018 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 manufacture(10742-1397)
