Label: POAGCI KETOCONAZOLE VCP-KAD001- ketoconazole liquid

  • NDC Code(s): 84745-002-01
  • Packager: Vince (Guangzhou) Cosmetics Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 11, 2024

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

  • Active Ingredients

    Ketoconazole 1% w/w

  • Purpose

    Anti-dandruff shampoo

  • Uses

    controls flaking, scaling and itching associated with dandruff

  • Warnings

    For external use only

  • Do not use

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

  • When using this product

    avoid contact with eyes
    if product gets into eyes, rinse thoroughly with water

  • Stop use and ask a doctor if

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

  • If pregnant or breast-feeding,

    ask a doctor before use.

  • Keep out of reach of children.

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

  • 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 dandruf

  • children under 12 years

    ask a doctor

  • Other information

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

  • Inactive ingredients

    Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamide DEA, Sodium Lauryl Sulfate, Dimethicone, Dimethiconol, Disodium Laureth Sulfosuccinate, Zinc Pyrithione, Phenoxyethanol, Fragrance, Sodium Cocoyl Alaninate, Caprylyl/Capryl Glucoside, Guar Hydroxypropyltrimonium Chloride, Salicylic Acid, Allantoin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyquaternium-67, Glycerin, Sodium Hydroxide, Cetrimonium Chloride, Benzoic Acid, Acrylamidopropyltrimonium Chloride/Acrylamide Copolymer, Piroctone Olamine, Laureth-23, Tea-Dodecylbenzenesulfonate, Sodium Polynaphthalenesulfonate, DMDM Hydantoin, Sodium Benzoate, Cellulose Gum, Ethylhexylglycerin, CI 16255

  • PRINCIPAL DISPLAY PANEL

    84745-002-01 Label

  • INGREDIENTS AND APPEARANCE
    POAGCI KETOCONAZOLE VCP-KAD001 
    ketoconazole liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84745-002
    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)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84745-002-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/11/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03210/11/2024
    Labeler - Vince (Guangzhou) Cosmetics Co., Ltd. (978423301)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vince (Guangzhou) Cosmetics Co., Ltd.978423301manufacture(84745-002)