Label: HEAD AND SHOULDERS  DRY SCALP- pyrithione zinc lotion/shampoo 

  • NDC Code(s): 37000-781-14, 37000-781-23, 37000-781-33, 37000-781-40
  • Packager: Procter & Gamble Manufacturing Co
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/14

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Pyrithione zinc 1%

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  • Purpose

    Anti-dandruff

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  • Uses

    helps prevent recurrence of flaking and itching associated with dandruff.

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  • Warnings

    For external use only.

    When using this product

    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

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

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

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  • Directions

    • for maximum dandruff control, use every time you shampoo.
    • wet hair, massage onto scalp, rinse, repeat if desired.
    • for best results use at least twice a week or as directed by a doctor.
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  • Inactive ingredients

    water, sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, zinc carbonate, glycol distearate, dimethicone, fragrance, cetyl alcohol, polyquaternium-10, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, benzyl alcohol, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate.

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  • Questions (or comments)?

    1-800-723-9569

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  • SPL UNCLASSIFIED SECTION

    www.headandshoulders.com
    Made in U.S.A. of US and/or imported ingredients.
    Dist. by Procter & Gamble, Cincinnati, OH 45202

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  • PRINCIPAL DISPLAY PANEL - 420mL Bottle Label

    head &
    shoulders®

    pyrithione zinc
    dandruff shampoo

    IMPROVES HAIR & SCALP
    HEALTH GUARANTEED

    dry scalp care
    with moisturizers,
    relieves dry scalp and itch

    14.2 FL OZ (420mL)

    Principal Display Panel - 420mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS   DRY SCALP
    pyrithione zinc lotion/shampoo
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37000-781
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Pyrithione Zinc (Pyrithione Zinc) Pyrithione Zinc 1 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    sodium laureth-3 sulfate  
    sodium lauryl sulfate  
    Coco Monoethanolamide  
    zinc carbonate  
    glycol distearate  
    dimethicone  
    cetyl alcohol  
    magnesium sulfate  
    sodium benzoate  
    magnesium carbonate hydroxide  
    benzyl alcohol  
    sodium chloride  
    methylchloroisothiazolinone  
    methylisothiazolinone  
    sodium xylenesulfonate  
    Product Characteristics
    Color TURQUOISE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-781-14 420 mL in 1 BOTTLE, PLASTIC
    2 NDC:37000-781-23 700 mL in 1 BOTTLE, PLASTIC
    3 NDC:37000-781-33 1000 mL in 1 BOTTLE, PLASTIC
    4 NDC:37000-781-40 1180 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 01/01/2006 02/24/2016
    Labeler - Procter & Gamble Manufacturing Co (004238200)
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