Label: HEAD AND SHOULDERS TEA TREE OIL DAILY- pyrithione zinc lotion/shampoo

  • NDC Code(s): 69423-416-01, 69423-416-37, 69423-416-40, 69423-416-95
  • 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 March 6, 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, glycol distearate, zinc carbonate, sodium chloride, fragrance, cocamidopropyl betaine, sodium xylenesulfonate, dimethicone, menthol, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, sodium laureth sulfate, mentha piperita (peppermint) flower/leaf/stemoil, mentha arvensis leaf/stem oil, melaleuca alternifolia (tea tree) leaf oil, yellow5, 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

    TEA TREE

    OIL

    DAILY SHAMPOO

    HYDRATES AND COOLS

    FOR SCALP RELIEF

    INFUSED with tea tree oil

    FLAKE FREE

    UP TO 100%

    GUARANTEED

    12.5 FL OZ (370 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS TEA TREE OIL DAILY 
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-416
    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
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-416-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/21/201901/01/2024
    2NDC:69423-416-95950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/15/202110/01/2023
    3NDC:69423-416-012 in 1 CELLO PACK01/15/202110/01/2023
    3950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    4NDC:69423-416-37370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03211/21/2019
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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