Label: NIZORAL- ketoconazole shampoo

  • NDC Code(s): 55505-196-33, 55505-196-40, 55505-196-47, 55505-196-64, view more
    55505-196-65, 55505-196-72
  • Packager: Kramer Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 13, 2023

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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

    benzyl alcohol, BHT, blue 1, citric
    acid, cocamide MEA, fragrance, glycol distearate, hydrochloric
    acid, hydroxypropyl methylcellulose, polyquaternium-7, sodium
    benzoate, 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.

    Use Nizoral® Anti-Dandruff just
    twice a week to control 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 Canada
    Distributed by:
    Kramer Laboratories, Inc.
    Bridgewater, NJ 08807
    USA

    © 2022 KRAMER
    LABORATORIES, INC.

    Lot:

    Exp:

    P819B46100

    Nizoral®

    Anti-Dandruff

    KETOCONAZOLE 1%
    ANTI-DANDRUFF SHAMPOO

    CONTROLS
    fungus that can cause dandruff

    Carton Label

    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)

    P819H46000

    200 mL front

    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)

    P809H45000

    125 mL front

    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

    11 fl oz (325mL)

    P829H47000

    325ml Front

    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

    14 fl oz (400 mL)

    P839H48000

    400 mL front

    SAMPLE

    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

    0.4 fl oz (12 mL)

    Sample Not For Sale

    12 mL Sample

    Nizoral®

    Anti-Dandruff

    KETOCONAZOLE 1%
    ANTI-DANDRUFF SHAMPOO 

    VALUE SIZE - TWO 11 OZ BOTTLES

    Anti-Dandruff
    Shampoo

    CLINICALLY PROVEN
    to control flaking, scaling and
    itching from dandruff

    CONTROLS
    fungus that can cause dandruff

    CLEAN
    fresh scent

    2 Bottles: 11 fl oz (325 mL) each
    Total 22 fl oz (650 mL)

    Use Nizoral® Anti-Dandruff
    just twice a week to control
    your dandruff symptoms.

    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.

    Anti-Dandruff
    Shampoo

    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 Canada

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

    © 2023 KRAMER
    LABORATORIES, INC.

    add new image 2x325 mL
  • INGREDIENTS AND APPEARANCE
    NIZORAL 
    ketoconazole shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-196
    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:55505-196-331 in 1 CARTON06/16/2022
    1125 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55505-196-401 in 1 CARTON06/16/2022
    2200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:55505-196-641 in 1 CARTON06/16/2022
    3325 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:55505-196-651 in 1 CARTON06/16/2022
    4400 mL in 1 CARTON; Type 0: Not a Combination Product
    5NDC:55505-196-474 mL in 1 PACKET; Type 0: Not a Combination Product03/01/2024
    6NDC:55505-196-722 in 1 CARTON12/01/2023
    6325 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02031006/16/2022
    Labeler - Kramer Laboratories (122720675)
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