Label: NIZORAL- ketoconazole shampoo

  • NDC Code(s): 55505-191-33, 55505-191-40
  • Packager: Kramer Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application Authorized Generic

Drug Label Information

Updated January 7, 2021

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

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Ketoconazole 1%Anti-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
  • KEEP OUT OF REACH OF CHILDREN

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

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

  • Questions or comments?

    call 1-800-824-4894

  • PRINCIPAL DISPLAY PANEL

    Nizoral®

    Anti-Dandruff

    KETOCONAZOLE 1%
    ANTI-DANDRUFF SHAMPOO


    Anti-Dandruff
    Shampoo


    CLINICALLY PROVEN
    to control flaking, scaling and
    itching from dandruff

    CONTROLS

    fungus that can cause dandruff

    CLEAN
    fresh scent

    7 fl oz (200mL)

    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.

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

    KRAMER
    LABORATORIES


    Made in Belgium

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

    © 2020 KRAMER
    LABORATORIES, INC.

    USA
    XXXXXX
    875

    55505-191-40carton

    Nizoral®

    Anti-Dandruff

    KETOCONAZOLE 1%
    ANTI-DANDRUFF SHAMPOO


    Anti-Dandruff
    Shampoo


    CLINICALLY PROVEN
    to control flaking, scaling and
    itching from dandruff

    CONTROLS
    fungus that can cause dandruff

    CLEAN
    fresh scent

    7 fl oz (200mL)

    55505-191-40front

    Dist. by: Kramer Laboratories, Inc., Bridgewater, NJ 08807 USA
    © 2020 Kramer Laboratories, Inc.
    Made in Belgium

    USA - XXXXXX

    LOT

    EXP
     

    55505-191-40back

    Nizoral®

    Anti-Dandruff

    KETOCONAZOLE 1% 
    ANTI-DANDRUFF SHAMPOO


    Anti-Dandruff 
    Shampoo


    CLINICALLY PROVEN
    to control flaking, scaling and 
    itching from dandruff

    CONTROLS 
    fungus that can cause dandruff

    CLEAN
    fresh scent

    4 fl oz (125mL)

    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.

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

    KRAMER
    LABORATORIES


    Made in Belgium 

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

    © 2020 KRAMER
    LABORATORIES, INC.

    USA
    XXXXXX 
    876

    55505-191-33carton

    Nizoral®

    Anti-Dandruff

    KETOCONAZOLE 1% 
    ANTI-DANDRUFF SHAMPOO


    Anti-Dandruff 
    Shampoo


    CLINICALLY PROVEN 
    to control flaking, scaling and 
    itching from dandruff

    CONTROLS 
    fungus that can cause dandruff

    CLEAN
    fresh scent

    4 fl oz (125mL)

    55505-191-33front

    Dist. by: Kramer Laboratories, Inc., Bridgewater, NJ 08807 USA 
    © 2020 Kramer Laboratories, Inc. 
    Made in Belgium 

    USA - XXXXXX

    LOT

    EXP

    55505-191-33back
  • INGREDIENTS AND APPEARANCE
    NIZORAL 
    ketoconazole shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-191
    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:55505-191-401 in 1 CARTON01/07/201908/01/2021
    1200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55505-191-33125 mL in 1 BOTTLE; Type 0: Not a Combination Product01/07/201908/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA02031001/07/201908/01/2021
    Labeler - Kramer Laboratories (122720675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Janssen Pharmaceutica NV370005019analysis(55505-191) , api manufacture(55505-191) , manufacture(55505-191) , pack(55505-191)