Label: OXY MAXIMUM ACTION ADVANCED FACE WASH- benzoyl peroxide cream
- NDC Code(s): 10742-8365-1
- Packager: The Mentholatum Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 21, 2013
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- Active ingredient
Benzoyl peroxide 10%Close
treats and helps prevent acneClose
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
If swallowed, get medical help or contact a Poison Control Center right away.Close
- 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.
- Other information
- THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS
- KEEP TIGHTLY CLOSED
- avoid storing at temperatures above 100°F (38°C)
- Inactive ingredients
anhydrous citric acid, butylene glycol, capryl/ capramidopropyl betaine, cetostearyl alcohol, cocamidopropyl betaine, diazolidinyl urea, disodium PEG-5 laurylcitrate sulfosuccinate, fragrance, hydrolyzed soy protein, hydroxyphenyl propamidobenzoic acid, methylparaben, PEG-8 dimethicone, pentylene glycol, propylparaben, purified water, sodium citrate, sodium lauroyl sarcosinate, xanthan gumClose
1-877-636-2677 MON-FRI 9 AM-5 PM (EST)Close
- Package/Label Principal Display Panel
- INGREDIENTS AND APPEARANCE
OXY MAXIMUM ACTION ADVANCED FACE WASH
benzoyl peroxide cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-8365 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) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 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) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-8365-1 147.7 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333D 01/15/2013 Labeler - The Mentholatum Company (002105757)