Label: HEAD AND SHOULDERS GREEN APPLE- pyrithione zinc lotion/shampoo

  • NDC Code(s): 37000-077-10, 37000-077-40, 37000-077-70
  • 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 09/14

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

    Water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, zinc carbonate, sodium chloride, sodium xylenesulfonate, cocamidopropyl betaine, dimethicone, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5.

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  • Questions (or comments)?

    1-800-723-9569

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  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

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  • PRINCIPAL DISPLAY PANEL - 700 mL Bottle Label

    NEW
    fresh scent
    technology

    head &
    shoulders®

    pyrithione zinc dandruff shampoo

    green apple

    fights dandruff with
    a crisp clean scent

    FLAKE FREE.*
    100%
    GUARANTEED^

    23.7 FL OZ
    (700 mL)

    96220925

    Principal Display Panel - 700 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS   GREEN APPLE
    pyrithione zinc lotion/shampoo
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37000-077
    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 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    sodium lauryl sulfate  
    sodium laureth-3 sulfate  
    glycol distearate  
    zinc carbonate  
    sodium chloride  
    sodium xylenesulfonate  
    cocamidopropyl betaine  
    dimethicone  
    sodium benzoate  
    magnesium carbonate hydroxide  
    methylchloroisothiazolinone  
    methylisothiazolinone  
    FD&C Blue No. 1  
    FD&C Yellow No. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-077-10 10 mL in 1 POUCH; Combination Product Type = C112160
    2 NDC:37000-077-70 700 mL in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
    3 NDC:37000-077-40 400 mL in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part358H 09/01/2013
    Labeler - Procter & Gamble Manufacturing Co. (004238200)
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