Label: IRISTAR ANTI DANDRUFF SHAMPOO.- ketoconazole shampoo lotion/shampoo

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

Drug Label Information

Updated March 29, 2024

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  • Active Ingredient

    Ketoconazole 1% w/w

  • Purpose

    Anti Dandruff Shampoo

  • Use

    controls flaking, scaling and itching associated with dandruff
    Warnings
    For external use only

  • Warnings

    For external use only

  • Do not use

    • on scalp that is damaged or inflamed
    • if vou are allergic to ingredients in this product

  • When Using

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

  • Stop Use

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

  • Ask Doctor

    If pregnant or breast-feeding, ask a doctor before use.

  • Keep Oot 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
    • 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 information

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

  • Inactive ingredients

    AQUA, LAURYL GLUCOSIDE, PALM KERNELAMIDE DEA, GLYCERIN, COCAMIDOPROPYL BETAINE, SODIUM CHLORIDE, POTASSIUM COCOYL GLYCINATE, POTASSIUM COCOATE, PHENOXYETHANOL, DIMETHICONOL, ALLANTOIN, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, HYDROLYZED COLLAGEN, HYDROLYZED ELASTIN, PANTHENOL, CENTELLA ASIATICA EXTRACT, CITRIC ACID, DISODIUM EDTA, PARFUM, METHYLISOTHIAZOLINONE, METHYLCHLOROISOTHIAZOLINONE

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    IRISTAR ANTI DANDRUFF SHAMPOO. 
    ketoconazole shampoo lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83462-018
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    POTASSIUM COCOYL GLYCINATE (UNII: WZ70FUF22U)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PALM KERNEL OIL (UNII: B0S90M0233)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V)  
    HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ)  
    HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83462-018-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/29/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03203/29/2024
    Labeler - Eubizrival LLC (036572203)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eubizrival LLC036572203label(83462-018) , manufacture(83462-018)
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