Label: OXY FACE WASH MAXIMUM ACITON- benzoyl peroxide lotion
- NDC Code(s): 10742-8397-1, 10742-8397-2
- 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.
Updated October 17, 2016
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- Active ingredient
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
- 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 one 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 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
anhydrous citric acid, butylene glycol, capryl/capramidopropyl betaine, cetostearyl alcohol, diazolidinyl urea, disodium laureth sulfosuccinate, fragrance, hydrolyzed soy protein, hydroxyphenyl propamidobenzoic acid, methylparaben, PEG-8 dimethicone, pentylene glycol, propylparaben, purified water, sodium C14-16 olefin sulfonate, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate, xanthan gum
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
OXY FACE WASH MAXIMUM ACITON
benzoyl peroxide lotion
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-8397 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E) SOY PROTEIN (UNII: R44IWB3RN5) HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-8 DIMETHICONE (UNII: GIA7T764OD) PENTYLENE GLYCOL (UNII: 50C1307PZG) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-8397-1 147.7 mL in 1 TUBE; Type 0: Not a Combination Product 08/01/2016 2 NDC:10742-8397-2 185 mL in 1 TUBE; Type 0: Not a Combination Product 08/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 08/01/2016 Labeler - The Mentholatum Company (002105757)