Label: OXY ADVANCED CARE RAPID SPOT TREATMENT- benzoyl peroxide gel
- NDC Code(s): 10742-1205-1
- Packager: The Mentholatum 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 14, 2023
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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.
- Keep out of 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 1 to 3 times daily
- 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.
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Inactive Ingredients
water, glycerin, butylene glycol, carbomer, chlorphenesin, citric acid, dimethyl isosorbide, disodium EDTA, fragrance, hydrated silica, hydrolyzed soy protein, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, phenoxyethanol, portulaca oleracea extract, propanediol, rhodomyrtus tomentosa fruit extract, sodium citrate, sodium hydroxide, xanthan gum
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INGREDIENTS AND APPEARANCE
OXY ADVANCED CARE RAPID SPOT TREATMENT
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-1205 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 WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) CHLORPHENESIN (UNII: I670DAL4SZ) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) EDETATE DISODIUM (UNII: 7FLD91C86K) HYDRATED SILICA (UNII: Y6O7T4G8P9) SOY PROTEIN (UNII: R44IWB3RN5) LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H) PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85) PHENOXYETHANOL (UNII: HIE492ZZ3T) PURSLANE (UNII: M6S840WXG5) PROPANEDIOL (UNII: 5965N8W85T) RHODOMYRTUS TOMENTOSA FRUIT (UNII: Q99511S58K) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM HYDROXIDE (UNII: 55X04QC32I) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-1205-1 2 g in 1 POUCH; Type 0: Not a Combination Product 03/31/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 03/31/2022 Labeler - The Mentholatum Company (002105757)