Label: REVIVE ACNE REPARATIF ACNE TREATMENT GEL- salicylic acid cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58411-414-60 - Packager: RéVive Skincare
- 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 January 10, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
- Warnings
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Directions
- clean the skin thoroughly before applying
- cover the entire affected area with a thin layer 1 to 3 times daily. Avoid eye area.
- as excess drying of the skin may occur, begin with 1 application daily then increase to 2 or 3 times daily, if needed, or as directed by a physician
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
- Other information
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Inactive ingredients
Water, Alcohol Denat., Cyclopentasiloxane, PVM/MA Decadiene Crosspolymer, Dimethicone, Oligopeptide-10, sh-Oligopeptide-1, Phenoxyethanol, PPG-26-Buteth-26, Sodium Hydroxide, Butylene Glycol, Panthenol, PEG-40 Hydrogenated Castor Oil, Polysilicone-11, Saccharomyces Lysate Extract, Glycerin, Caprylyl Glycol, Chlorphenesin, Decyl Glucoside, Avena Sativa (Oat) Kernel Extract, Hexylene Glycol, Potassium Sorbate, Citrus Aurantium Dulcis (Orange) Peel Oil, Citric Acid, Pantolactone, Limonene.
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- PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton
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INGREDIENTS AND APPEARANCE
REVIVE ACNE REPARATIF ACNE TREATMENT GEL
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-414 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) OLIGOPEPTIDE-10 (UNII: Q46328TRNK) NEPIDERMIN (UNII: TZK30RF92W) PHENOXYETHANOL (UNII: HIE492ZZ3T) PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P) SODIUM HYDROXIDE (UNII: 55X04QC32I) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PANTHENOL (UNII: WV9CM0O67Z) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) OAT (UNII: Z6J799EAJK) HEXYLENE GLYCOL (UNII: KEH0A3F75J) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ORANGE OIL (UNII: AKN3KSD11B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PANTOLACTONE, (R)- (UNII: J288D7O0JS) LIMONENE, (+)- (UNII: GFD7C86Q1W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-414-60 1 in 1 CARTON 09/01/2008 1 30 mL 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 final part333D 09/01/2008 Labeler - RéVive Skincare (193691821)