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

  • NDC Code(s): 37000-077-01, 37000-077-02, 37000-077-25, 37000-077-37, view more
    37000-077-40, 37000-077-61, 37000-077-70, 37000-077-83, 37000-077-95
  • Packager: The Procter & Gamble Manufacturing Company
  • 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 February 27, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione zinc 1%

  • Purpose

    Anti-dandruff

  • Uses

    helps prevent recurrence of flaking and itching associated with dandruff.

  • 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.

  • 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.
  • Inactive ingredients

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

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 370 mL Bottle Label

    head &

    shoulders ®

    pyrithione zinc dandruff shampoo

    green apple

    daily shampoo

    with a lasting fresh scent

    FLAKE FREE.*
    UP TO
    100%
    GUARANTEED^

    12.5 FL OZ
    (370 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS  GREEN APPLE
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-077-70700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/201312/01/2024
    2NDC:37000-077-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/201312/01/2024
    3NDC:37000-077-011000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/201302/16/2017
    4NDC:37000-077-25250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/201603/05/2021
    5NDC:37000-077-95950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/201612/01/2024
    6NDC:37000-077-022 in 1 CELLO PACK06/01/2022
    6950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:37000-077-37370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2022
    8NDC:37000-077-61613 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2022
    9NDC:37000-077-83835 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03209/01/2013
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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