Label: 1% KETOCONAZOLE ANTI DANDRUFF- 1% ketoconazole anti dandruff shampoo shampoo

  • NDC Code(s): 84558-005-01
  • Packager: GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 3, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    Ketoconazole 1%

  • Purpose

    Anti-dandruff shampoo

  • Use

    controls flaking, scaling and itching from dandruff

  • Warnings

    For external use only

  • Do not use

    on scalp that is broken or inflamed

    if there is a known sensitivity to any of the ingredients

  • WHEN USING

    avoid contact with eyes
    in case of such contact, rinse well with water

  • STOP USE

    rash appears
    condition worsens or does not improve in 2-4 weeks

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or
    contact a Poison Control Center right away,

  • Directions

    adults and children 12 years and over:①wet hair thoroughly ②apply shampoo, generously lather, rinse thoroughly. Repeat
    ③use every 3-4 days for up to 8 weeks or as directed by a doctor,' Then use only as needed to control dandruff

    children under 12 years: ask a doctor


  • Other information

    ①store at 20°C to 25°C (68*F-77°F)
    ②see bottom panel for expiration date

  • Inactive ingredients

    Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide Dea, Dimethicone, Sodium Chloride, Glycol Distearate,
    Amino BispropyI Dimethicone, Fragrance, Polyquaternium-10, Carbomer, Azelaic Acid, L aurtrimonium Chloride, Guar
    Hydroxypropyltrimonium Chloride, Methylisothiazolinone, Citric Acid, Coco/Oleamidopropyl Betaine, Dodecylbenzene Sulfonic
    Acid, C12-15 Pareth-3, Hydroxypropyltrimonium Hydrolyzed Collagen, Triethanolamine, Phenoxyethanol, AO1

  • Package Label - Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    1% KETOCONAZOLE ANTI DANDRUFF 
    1% ketoconazole anti dandruff shampoo shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84558-005
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9)  
    AQUA (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCAMIDE DEA (UNII: 92005F972D)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    CARBOMER (UNII: 0A5MM307FC)  
    AZELAIC ACID (UNII: F2VW3D43YT)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: B16G315W7A)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    C12-15 PARETH-3 (UNII: 459EF9MP3Y)  
    COCO/OLEAMIDOPROPYL BETAINE (UNII: 5M84PX7JN2)  
    TRIETHANOLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84558-005-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product12/04/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)12/04/2024
    Labeler - GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd (545488483)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd545488483manufacture(84558-005)