Label: PHISODERM CLEAR CONFIDENCE SPOT TREATMENT- benzoyl peroxide cream
- NDC Code(s): 10742-8293-1
- Packager: The Mentholatum Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 17, 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
- 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.
- 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
anhydrous citric acid, butylene glycol, carbomer homopolymer, diazolidinyl urea, dimethicone, dimethyl isosorbide, edetate disodium, fragrance, glycerin, iodopropynyl butylcarbamate, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, portulaca oleracea extract, propylene glycol, purified water, silica, sodium citrate, sodium hydroxide, xanthan gum
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INGREDIENTS AND APPEARANCE
PHISODERM CLEAR CONFIDENCE SPOT TREATMENT
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-8293 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 25 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) 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) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-8293-1 1 in 1 CARTON 08/01/2013 1 18.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 08/01/2013 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 manufacture(10742-8293)
