Label: VICHY LABORATOIRES NORMADERM PHYTOACTION DAILY DEEP CLEANSING- salicylic acid gel

  • NDC Code(s): 49967-307-01, 49967-307-02, 49967-307-03, 49967-307-04, view more
    49967-307-05, 49967-307-06, 49967-307-07
  • Packager: L'Oreal USA Products 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 December 14, 2022

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  • Active ingredient

    Salicylic acid...0.5%

  • Purpose

    Acne treatment

  • Use

    for the treatment of acne

  • Warnings

    For external use only

  • When using this product

    kin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne medication at a time.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • use twice daily
    • wet face, then work product into a lather
    • massage onto face avoiding the eyes
    • rinse well
  • Inactive ingredients

    water, coco-betaine, propanediol, PEG-120 methyl glyucose dioleate, sodium chloride, sodium cocoyl glycinate, dipropylene glycol, zinc gluconate, bifida ferment lysate, sodium hydroxide, sodium benzoate, phenoxyethanol, copper gluconate, caprylyl glycol, tetrasodium glutamate diacetate, fragrance

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • INGREDIENTS AND APPEARANCE
    VICHY LABORATOIRES NORMADERM PHYTOACTION DAILY DEEP CLEANSING 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-307
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-307-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    2NDC:49967-307-027 mL in 1 PACKET; Type 0: Not a Combination Product04/29/2020
    3NDC:49967-307-0350 mL in 1 BOTTLE; Type 0: Not a Combination Product08/18/202008/18/2020
    4NDC:49967-307-0415 mL in 1 BOTTLE; Type 0: Not a Combination Product08/18/202008/18/2020
    5NDC:49967-307-05400 mL in 1 BOTTLE; Type 0: Not a Combination Product11/15/2022
    6NDC:49967-307-0650 mL in 1 TUBE; Type 0: Not a Combination Product08/18/2020
    7NDC:49967-307-0715 mL in 1 TUBE; Type 0: Not a Combination Product08/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/15/2020
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMETIQUE ACTIVE PRODUCTION282658798manufacture(49967-307) , pack(49967-307)
    Establishment
    NameAddressID/FEIBusiness Operations
    Socoplan276221405pack(49967-307)
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