Label: PCA SKIN INTENSIVE CLARITY TREATMENT- salicylic acid gel
- NDC Code(s): 68726-359-01, 68726-359-02, 68726-359-03
- 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
- Uses
- Warnings
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Directions
- Cleanse the skin thoroughly before applying this product.
- Cover the entire affected area with a thin layer one to three times daily.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once daily or every other day.
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Inactive Ingredients
Water, Glycerin, PEG-12 Glyceryl Dimyristate, Cyclopentasiloxane, Isododecane, Niacinamide, Butylene Glycol, Dimethicone, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetearyl Alcohol, Isoamyl Laurate, Glyceryl Stearate, PEG-100 Stearate, Sodium Polyacrylate,
Polysilicone-11, Bakuchiol, Caprylic/Capric Triglyceride, Maltodextrin, Phenoxyethanol, Coco-Caprylate/Caprate, Hexyl Resorcinol, Ethylhexyl Stearate, Retinol, Ethyl Linoleate, Polysorbate 20, Hexylresorcinol, Dipotassium Glycrrhizinate, Caprylyl Glycol, Trideceth-6, Xanthan Gum, Chlorphenesin, Pentylene Glycol, Isoamyl Cocoate, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, Sodium Citrate, Disodium EDTA, Decyl Glucoside, Myristoyl Nonapeptide-3, Citric Acid - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PCA SKIN INTENSIVE CLARITY TREATMENT
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68726-359 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PEG-12 GLYCERYL DIMYRISTATE (UNII: VS4W16AQ3X) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ISODODECANE (UNII: A8289P68Y2) NIACINAMIDE (UNII: 25X51I8RD4) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ISOAMYL LAURATE (UNII: M1SLX00M3M) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) BAKUCHIOL (UNII: OT12HJU3AR) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MALTODEXTRIN (UNII: 7CVR7L4A2D) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCO-CAPRYLATE (UNII: 4828G836N6) RETINOL (UNII: G2SH0XKK91) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) ETHYL LINOLEATE (UNII: MJ2YTT4J8M) HEXYLRESORCINOL (UNII: R9QTB5E82N) POLYSORBATE 20 (UNII: 7T1F30V5YH) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) CAPRYLYL GLYCOL (UNII: 00YIU5438U) XANTHAN GUM (UNII: TTV12P4NEE) CHLORPHENESIN (UNII: I670DAL4SZ) TRIDECETH-6 (UNII: 3T5PCR2H0C) PENTYLENE GLYCOL (UNII: 50C1307PZG) ISOAMYL COCOATE (UNII: 14OG46E98E) SYRINGA VULGARIS FLOWER (UNII: 9V5O040S3W) SODIUM CITRATE (UNII: 1Q73Q2JULR) EDETATE DISODIUM (UNII: 7FLD91C86K) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68726-359-02 1 in 1 CARTON 06/08/2018 1 NDC:68726-359-01 29.5 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68726-359-03 2 g in 1 TUBE; Type 0: Not a Combination Product 06/08/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 06/08/2018 Labeler - CP Skin Health Group, Inc. (611921669)
