Label: NIZORAL- ketoconazole shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated September 20, 2024

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  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Ketoconazole 1% w/wAnti-dandruff shampoo
  • INDICATIONS & USAGE

    Uses 
    controls flaking, scaling and itching associated with dandruff

  • WARNINGS

    Warnings
    For external use only

  • Do not use

    • on scalp that is broken or inflamed
    • if you are allergic to ingredients in this product
  • 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
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the 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
    • 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

    water, sodium laureth sulfate,
    sodium cocoyl sarcosinate, cocamide MEA, glycol distearate,
    benzyl alcohol, hydroxypropyl methylcellulose, polyquaternium-7,
    tetrasodium EDTA, fragrance, sodium chloride, BHT, citric acid,
    hydrochloric acid, sodium hydroxide, blue 1

  • Questions or comments?

    call 1-800-824-4894

    K0524

  • PRINCIPAL DISPLAY PANEL

    NEW!
    Shampoo + conditioner

    Nizoral®

    Anti-Dandruff

    KETOCONAZOLE 1%
    ANTI-DANDRUFF SHAMPOO 

    2-IN-1
    Anti Drandruff
    Shampoo +
    Conditioner

    CLINICALLY PROVEN
    to control flaking, scaling and
    itching from dandruff

    CONTROLS
    fungus that can cause dandruff

    CONDITIONS
    leaves hair soft, smooth & manageable

    14 fl oz (400mL)

    What Causes
    Dandruff?
    Dandruff can have many
    causes. A fungus found on
    every human head is often
    associated with dandruff.

    How Does Nizoral® 
    Anti-Dandruff Work?
    NIZORAL® Anti-Dandruff is
    the only over-the-counter
    anti-dandruff shampoo
    that has Ketoconazole,
    an effective antifungal.
    Ketoconazole works by
    controlling fungus often
    associated with dandruff,
    and once the fungus is
    controlled, so are your
    dandruff symptoms.

    Nizoral®
    Anti-Dandruff
    KETOCONAZOLE 1%
    ANTI-DANDRUFF SHAMPOO 

    Nizoral® 2-IN-1
    Anti-Dandruff
    Shampoo +
    Conditioner
    is formulated with more
    conditioning properties
    to help leave hair soft,
    smooth, and manageable.

    KRAMER
    LABORATORIES

    Made in Canada
    Distributed by:
    Kramer Laboratories, Inc.
    Bridgewater, NJ 08807 USA

    © 2024 KRAMER
    LABORATORIES, INC.

    Before use, read all label
    information. If you have a
    drug reaction, contact a
    doctor and report it by calling:
    1.800.824.4894

    P238B1500

    Lot:

    Exp:         YYYY-MM

    400mL Carton
  • INGREDIENTS AND APPEARANCE
    NIZORAL 
    ketoconazole shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-233
    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
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Coco Monoethanolamide (UNII: C80684146D)  
    Glycol Distearate (UNII: 13W7MDN21W)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw) (UNII: 0L414VCS5Y)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Cocoyl Sarcosinate (UNII: 1R9DUY89CZ)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55505-233-65400 mL in 1 CARTON; Type 0: Not a Combination Product11/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02031011/01/2024
    Labeler - Kramer Laboratories (122720675)
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