Label: NIZORAL- ketoconazole shampoo

  • NDC Code(s): 55505-192-33, 55505-192-40, 55505-192-57, 55505-192-59
  • Packager: Kramer Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 11, 2023

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  • 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
  • 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 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® 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

    © 2022 KRAMER
    LABORATORIES, INC.


    USA
    753769
    875

    200mL Carton

    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)

    USA -753767

    200 mL front

    Dist. by: Kramer Laboratories, Inc., Bridgewater, NJ 08807 USA
    © 2022 Kramer Laboratories, Inc.
    Made in Belgium

    USA - 753768

    LOT

    EXP

    200 mL back

    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® 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

    © 2022 KRAMER
    LABORATORIES, INC.


    USA
    753764
    876

    125mL Carton

    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)

    USA -753765

    125 mL front

    Dist. by: Kramer Laboratories, Inc. Bridgewater, NJ 08807 USA
    © 2022 Kramer Laboratories, Inc.
    Made in Belgium

    USA - 753766

    LOT

    EXP

    125 ml back

    BUY 2 AND SAVE!

    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

    2 Bottles: 7 fl oz (200 mL) each
    Total 14 fl oz (400 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.

    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

    © 2021 KRAMER
    LABORATORIES, INC.

    Nizoral Twin Pack 2 x.200ml

    value packs xxx

    Nizoral Value packs 2 x 200 mL + 125 mL
  • INGREDIENTS AND APPEARANCE
    NIZORAL 
    ketoconazole shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-192
    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)  
    Hypromelloses (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:55505-192-401 in 1 CARTON01/07/2019
    1200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55505-192-331 in 1 CARTON11/01/2019
    2125 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:55505-192-572 in 1 CARTON11/01/2019
    31 in 1 CARTON
    3200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:55505-192-592 in 1 CARTON11/01/2019
    4325 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02031001/07/2019
    Labeler - Kramer Laboratories (122720675)
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