Label: OXY MAXIMUM ACTION SPOT TREATMENT TINTED- benzoyl peroxide cream
- NDC Code(s): 10742-8302-1
- Packager: The Mentholatum Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated January 7, 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
- clean skin thoroughly before applying this product
- cover 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.
- Other information
- avoid storing at temperatures above 100°F (38°C)
- Inactive ingredients
anhydrous citric acid, butylene glycol, carbomer homopolymer, diazolidinyl urea, dimethicone, dimethyl isosorbide, edetate disodium, fragrance, glycerin, iodopropynyl butylcarbamate, iron oxides, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG-8 methyl ether triethoxysilane, PEG/PPG-4/12 dimethicone, portulaca oleracea extract, propylene glycol, purified water, silica, sodium citrate, sodium hydroxide, talc, titanium dioxide, xanthan gumClose
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- Package/Label Principal Display Panel
- INGREDIENTS AND APPEARANCE
OXY MAXIMUM ACTION SPOT TREATMENT TINTED
benzoyl peroxide cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-8302 Route of Administration TOPICAL DEA Schedule 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H) PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85) PURSLANE (UNII: M6S840WXG5) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM HYDROXIDE (UNII: 55X04QC32I) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-8302-1 1 in 1 CARTON 1 18.4 g 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)