Label: PYRITHIONE ZINC- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 19, 2018

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

  • Pyrithione Zinc 1%
  • PURPOSE

    Purpose:

    Anti Dandruff

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  • WHEN USING

    USE

    Helps prevent recurrence of flaking and itching associated with dandruff

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  • WARNINGS

    WARNINGS

    For external use only.

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  • WHEN USING

    WHEN USING THIS PRODUCT

    Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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  • STOP USE

    STOP USE AND ASK A DOCTOR IF

    Condition worsens or does not improve after regular use of this product as directed

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  • ASK DOCTOR

    STOP USE AND ASK A DOCTOR IF

    Condition worsens or does not improve after regular use of this product as directed.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    If swallowed, get medical help or contact Poison Control Center right away.

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  • INSTRUCTIONS FOR USE

    DIRECTIONS

    For maximum dandruff control, use every time you shampoo

    Wet hair, massage onto scalp, rinse, and repeat if desired

    For best results use least twice a week or as directed by a doctor

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  • QUESTIONS

    QUESTION OR COMMENTS?

    1-800-241-4168

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  • INACTIVE INGREDIENT

    Aqua, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Acrylates Copolymer, Cocamide MEA, Cocamidopropylamine Oxide, Caprylyl Glycol, Parfum, Sodium Hydroxide, Polyquaternium-7, Parfum, Panthenol, Disodium EDTA, Methylisothiazolinone, Citric Acid, D&C Violet # 2(CI 60730), FD&C Blue #1 (CI 42090), FD&C Yellow #5 (CI 19140), Linalool, Benzyl Benzoate, Lilial, D ‘Limonene, Citral, Benzyl Cinnamate.

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION SECTION

    It is not a product for human consumption

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  • INDICATIONS & USAGE

    Use every time you shampoo

    Wet hair, massage onto scalp, rinse, and repeat if desired

    For best results use least twice a week or as directed by a doctor.

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  • INGREDIENTS AND APPEARANCE
    PYRITHIONE ZINC 
    pyrithione zinc shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:72141-001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 2.41 g  in 237 mL
    Inactive Ingredients
    Ingredient Name Strength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    .ALPHA.,.ALPHA.-DIMETHYLBENZYL ALCOHOL (UNII: JE030BGE05)  
    COCAMIDE (UNII: 3YXD33R71G)  
    PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:72141-001-10 295.7 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 02/28/2018
    Labeler - CARSON LIFE, INC (059260332)
    Registrant - Chemco Corporation (032495954)
    Establishment
    Name Address ID/FEI Business Operations
    Chemco Corporation 032495954 manufacture(72141-001)
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