Label: PCA SKIN ACNE- benzoyl perozide cream
- NDC Code(s): 68726-169-01, 68726-169-02, 68726-169-04
- 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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- 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.
- For external use only
- Using other topical acne drugs at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a physician.
- Do not use in or near the eyes.
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DOSAGE & ADMINISTRATION
DIRECTIONS: Cleanse skin thoroughly before applying. Apply a small amount of cream to areas where pimples occur. Do not rinse. Start with one acne treatment every other day and gradually increase to once daily or as directed by a physician. If going outside, use a sunscreen. Allow Acne Cream to dry, then follow sunscreen label directions. If irritation develops or sensitivity develops, discontinue use of both products and consult a physician.
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INACTIVE INGREDIENT
Other Ingredients: Water/Aqua/Eau, Gluconolactone, Glycerin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Vitis Vinifera (Grape) Seed Oil, Aminomethyl Propanol, Lactic Acid, Aloe Barbadensis Leaf Juice, Cyclopentasiloxane, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Melaleuca Arternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Anthemis Nobilis Flower Extract, Citrus Grandis (Grapefruit) Peel Oil, Allantoin, Panthenol, Polyacrylate-13, Polyisobutene, Caprylyl Glycol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Potassium Cetyl Phosphate, Ethylhexylglycerin, Hexylene Glycol, Polysorbate 20, Butylene Glycol, Phenoxyethanol.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PCA SKIN ACNE
benzoyl perozide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68726-169 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 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALLANTOIN (UNII: 344S277G0Z) PANTHENOL (UNII: WV9CM0O67Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXYLENE GLYCOL (UNII: KEH0A3F75J) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYSORBATE 20 (UNII: 7T1F30V5YH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLUCONOLACTONE (UNII: WQ29KQ9POT) CETYL ALCOHOL (UNII: 936JST6JCN) GRAPE (UNII: 6X543N684K) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) LACTIC ACID (UNII: 33X04XA5AT) CITRUS PARADISI SEED (UNII: 12F08874Y7) TEA TREE OIL (UNII: VIF565UC2G) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYOXYL 100 STEARATE (UNII: YD01N1999R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ASCORBIC ACID (UNII: PQ6CK8PD0R) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68726-169-04 1 in 1 CARTON 04/01/2010 1 NDC:68726-169-01 14 g in 1 JAR; Type 0: Not a Combination Product 2 NDC:68726-169-02 7 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2010 08/31/2021 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)
