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

  • NDC Code(s): 69423-521-01, 69423-521-37, 69423-521-40, 69423-521-83, view more
    69423-521-95
  • 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 30, 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, cocamidopropyl betaine, fragrance, sodium xylenesulfonate, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride,magnesium carbonate hydroxide, sodium laureth sulfate, apple cider vinegar, methylchloroisothiazolinone, methylisothiazolinone

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

    head &

    shoulders ®

    pyrithione zinc dandruff shampoo

    Apple Cider Vinegar

    Daily Shampoo

    Clarifies Scalp & Restores Shine to Hair

    Infused with Apple Cider Vinegar

    FLAKE FREE.*


    UP TO 100%

    GUARANTEED^

    12.5 FL OZ (370 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS APPLE CIDER VINEGAR 
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-521
    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
    APPLE CIDER VINEGAR (UNII: 0UE22Q87VC)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-521-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/17/202012/15/2024
    2NDC:69423-521-012 in 1 CELLO PACK11/17/202010/01/2023
    2950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:69423-521-95950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/17/202012/15/2024
    4NDC:69423-521-37370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/2022
    5NDC:69423-521-83835 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03211/17/2020
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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