Label: PCA SKIN BPO CLEANSER- benzoyl peroxide gel
- NDC Code(s): 68726-168-01, 68726-168-02, 68726-168-04
- Packager: CP Skin Health Group, Inc.
- 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 3, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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WARNINGS
Warnings: When using this product,avoid unnecessary sun exposure and use a sunscreen.
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For external use only.
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Using other topical acne drugs at the same time or immediately following the sue of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be sued unless directed by a physician.
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Do not use in or near the eyes.
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients: Water/Aqua/Eau, Gluconolactone, Sodium C14-16 Olefin Sulfonate, Aminomethyl Propanol, Glycerin, Cocamidopropyl Betaine, Aloe Babadensis Leaf Juice, Sodium PCA, Tocopheryl Acetate, Allantoin, Panthenol, Phytic Acid, Triticum Vulgare (Wheat) Germ Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Anthemis Nobilis Flower Extract, Vitis Vinifera (Grape) Seed Extract, Cucumis Sativus (Cucumber) Fruit Extract, Arnica Montana Flower Extract, Algae Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate-13, Caprylyl Glycol, Polisobutene, Ehtylhexylglycerin, Hexylene Glycol, Polysorbate 20, Butylene Glycol, Phenoxyethanol, Citrus Grandis (Grapefruit) Peel Oil.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PCA SKIN BPO CLEANSER
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68726-168 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYSORBATE 20 (UNII: 7T1F30V5YH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLUCONOLACTONE (UNII: WQ29KQ9POT) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) ARNICA MONTANA (UNII: O80TY208ZW) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) CUCUMBER (UNII: YY7C30VXJT) GRAPE (UNII: 6X543N684K) CITRUS PARADISI SEED (UNII: 12F08874Y7) WHEAT GERM (UNII: YR3G369F5A) ALLANTOIN (UNII: 344S277G0Z) PANTHENOL (UNII: WV9CM0O67Z) FYTIC ACID (UNII: 7IGF0S7R8I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68726-168-04 1 in 1 CARTON 04/01/2010 1 NDC:68726-168-01 206.5 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:68726-168-02 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2010 01/31/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 04/01/2010 Labeler - CP Skin Health Group, Inc. (611921669)
