Label: 1% KETOCONAZOLE- ketoconazole shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 19, 2025

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  • ACTIVE INGREDIENT

    ketoconazole 1%

  • PURPOSE

    Anti Dandruff

  • INDICATIONS & USAGE

    • Targets Stubborn Dandruff, Seborrheic Dermatitis, and itching
    • ​Prevention, Treatment, and control of fungus that can cause dandruff
  • WARNINGS

    For external use only

    on the scalp that is broken or inflamed if you are allergic to ingredients in this product

    do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

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

    ask a doctor before use

    If swallowed, get medical help or contact a Posion Control Center immediately

  • DOSAGE & ADMINISTRATION

    adults and children
    12 years and over
    • wet hair thoroughly
    • apply shampoo, generously lather, rinse thoroughly. Repeat
    • use 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 old • Ask a doctor

  • OTHER SAFETY INFORMATION

  • OTHER SAFETY INFORMATION

    • store at 20°C to 25°C (68°F-77°F)
    • see top panel for lot number and expiration date

  • QUESTIONS

    Support@tagridllc.com

  • INACTIVE INGREDIENT

    Citric Acid, Herba Violae, Euphorbia Hirta, Murraya Paniculata ,Mentha Canadensis, Sophora Flavescens, Dittany Bark, Glabrous Greenbrier Rhizome, Mosla Cavaleriei Levl ,Stellera Chamaejasme, Huang Bai, Sessile Stemona Root, Gleditsia Sinensis, Common Cnidium Fruit, Fructus Kochiae, Tea Tree Oil, Water

  • PRINCIPAL DISPLAY PANEL

    scalp shampoo

  • INGREDIENTS AND APPEARANCE
    1% KETOCONAZOLE 
    ketoconazole shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85384-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    STEMONA SESSILIFOLIA ROOT (UNII: EKG8030U4N)  
    GLEDITSIA SINENSIS THORN (UNII: 26LKE578NY)  
    CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)  
    MURRAYA PANICULATA ROOT BARK (UNII: 20IWV81WFV)  
    DICTAMNUS DASYCARPUS ROOT BARK (UNII: LA97176ILS)  
    STELLERA CHAMAEJASME WHOLE (UNII: 80N0P0DD9J)  
    MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    SMILAX GLABRA TUBER (UNII: PES3YXA3LR)  
    WATER (UNII: 059QF0KO0R)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    MENTHA CANADENSIS TOP OIL (UNII: N2285224W8)  
    EUPHORBIA HIRTA (UNII: L13YF113GN)  
    MOSLA CAVALERIEI WHOLE (UNII: 05O8B64OS2)  
    VIOLA YEZOENSIS WHOLE (UNII: 9OI75F9NAC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85384-0001-1250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/31/2025
    Labeler - TAGRID LLC (118778969)
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