Label: ANTI DANDRUFF- ketoconazole shampoo

  • NDC Code(s): 85593-033-01
  • Packager: Guangzhou ChuanMa International Trading Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 2, 2026

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  • ACTIVE INGREDIENT

    ketoconazole 1%

  • PURPOSE

    Anti Dandruff

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • WARNINGS

    For external use only

  • INDICATIONS & USAGE

    For best results, follow these stepscarefully:1.Wet hair and scalp thoroughly with
    lukewarm water.
    2.Apply a sufficient amount of shampoo to
    generate a rich lather.
    3.Gently massage the lather into your scalp
    and hair.4.Leavethe latheron the scalp for3-5minutes. This contact time is crucialforthemedication to work effectively.5.Rinse thoroughly with water.

  • DOSAGE & ADMINISTRATION

    Use every 3-4 days for up to 8 weeks. Afterthat, use only as needed to control dandruff.

  • INACTIVE INGREDIENT

    Aqua, Sodium Laureth Sulfate, Cocamide DEA,Sodium Chloride, Cocamidopropyl Betaine,Ammonium LaurylSulfate, Ketoconazole,Fragrance, Phenoxyethanol, PEG-7 GlycerylCocoate, Bis-Aminopropyl Dimethicone,Hydroxypropyl Guar HydroxypropyltrimoniumChloride, C12-13 Pareth Lactate, CitricAcid, C11-15 Pareth-9, Trideceth-12, Sodium Benzoate.

  • PRINCIPAL DISPLAY PANEL

    labeling

  • INGREDIENTS AND APPEARANCE
    ANTI DANDRUFF 
    ketoconazole shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85593-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    HYDROXYPROPYL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: MVW5LK6LFT)  
    C12-13 ALKYL LACTATE (UNII: 9GLX7JL13M)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    C11-15 PARETH-9 (UNII: U6S376X80D)  
    AMINOPROPYL DIMETHICONE (2000 MPA.S) (UNII: K3CD5CYV6S)  
    COCAMIDE DEA (UNII: 92005F972D)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRIDECETH-12 (UNII: YFY3KG5Y7O)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    AQUA (UNII: 059QF0KO0R)  
    SODIUM LAURETH-2 SULFATE (UNII: ZZQ59TY3KG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85593-033-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/14/2026
    Labeler - Guangzhou ChuanMa International Trading Co.,Ltd. (510247477)
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