Label: OIL-FREE ACNE CLEANSER- benzoyl peroxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50544-001-06 - Packager: University Medical Pharmaceuticals Corp
- 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 November 1, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingredients: Water, Disodium Laureth Sulfosuccinate, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Glycerin, Cocamidopropyl Betaine, Bakuchiol, Panthenyl Triacetate, Bisabolol, Benzalkonium Chloride, Chamomilla Recuita (Matricaria) Flower Extract, Naringenin, Sea Whip Extract, Polyethylene, Xanthan Gum, Cetyl Alcohol, Magnesium Aluminum Silicate, Sodium Benzoate, Caprylic/Capric Triglyeride, Farnesol, Phenoxyethanol, Ethylhexylglycerin, Methylisothiazolinone.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OIL-FREE ACNE CLEANSER
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50544-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (benzoic acid - UNII:8SKN0B0MIM) Benzoyl Peroxide 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) STEARIC ACID (UNII: 4ELV7Z65AP) glycerin (UNII: PDC6A3C0OX) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) LEVOMENOL (UNII: 24WE03BX2T) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) XANTHAN GUM (UNII: TTV12P4NEE) CETYL ALCOHOL (UNII: 936JST6JCN) CETYL ESTERS WAX (UNII: D072FFP9GU) SODIUM BENZOATE (UNII: OJ245FE5EU) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50544-001-06 237 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 11/01/2011 Labeler - University Medical Pharmaceuticals Corp (809706252) Registrant - University Medical Pharmaceuticals Corp (809706252) Establishment Name Address ID/FEI Business Operations Universal Packaging Systems, INC 177711082 manufacture