Label: NIZORAL A-D- ketoconazole shampoo

  • NDC Code(s): 50580-895-04, 50580-895-07, 50580-895-14, 50580-895-15
  • Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 10, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Ketoconazole 1%

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  • Purpose

    Anti-dandruff shampoo

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  • Uses

    controls flaking, scaling and itching associated with dandruff

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  • 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

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • 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
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  • Other information

    • store between 35° and 86°F (2° and 30°C)
    • protect from light
    • protect from freezing
    • see top panel for lot number and expiration date
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  • Inactive ingredients

    acrylic acid polymer (carbomer 1342), butylated hydroxytoluene, cocamide MEA, FD&C Blue #1, fragrance, glycol distearate, polyquaternium-7, quaternium-15, sodium chloride, sodium cocoyl sarcosinate, sodium hydroxide and/or hydrochloric acid, sodium laureth sulfate, tetrasodium EDTA, water-

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  • Questions or comments?

    call 1-800-962-5357

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  • PRINCIPAL DISPLAY PANEL

    NON-PRESCRIPTION STRENGTH

    NDC 50580-895-04

    Nizoral®
    A-D KETOCONAZOLE SHAMPOO 1%

    Anti-Dandruff
    Shampoo

    CONTROLS FLAKING,
    SCALING AND ITCHING

    The Freedom Will Go To Your Head

    4 FL OZ (125 mL)

    Principal Display Panel
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  • INGREDIENTS AND APPEARANCE
    NIZORAL   A-D
    ketoconazole shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-895
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Ketoconazole (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I) Ketoconazole 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Carbomer copolymer type b (allyl pentaerythritol crosslinked) (UNII: 809Y72KV36)  
    Butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    Coco Monoethanolamide (UNII: C80684146D)  
    FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
    Glycol Distearate (UNII: 13W7MDN21W)  
    hydrochloric acid (UNII: QTT17582CB)  
    Quaternium-15 (UNII: E40U03LEM0)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sodium laureth-3 sulfate (UNII: BPV390UAP0)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    Color BLUE (opaque, pearlescent blue to blue green) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50580-895-04 1 in 1 CARTON 04/01/1999
    1 125 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:50580-895-07 1 in 1 CARTON 04/01/1999
    2 200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:50580-895-14 1 in 1 CARTON 04/01/1999
    3 125 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:50580-895-15 10 in 1 CARTON 04/01/1999
    4 6 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020310 04/01/1999
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
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