Label: HEAD AND SHOULDERS SHEA BUTTER HAIR AND SCALP CONDITIONER- pyrithione zinc oil

  • NDC Code(s): 69423-669-32
  • 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 28, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione zinc 0.5%

  • 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.
    • apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.
  • Inactive ingredients

    Water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, glutamic acid, dimethicone, fragrance, phenoxyethanol, benzyl alcohol, citric acid, sodium chloride, butyrospermumparkii(shea) butter, methylchloroisothiazolinone, methylisothiazolinone, yellow 5, red 33, blue 1

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 325 mL Tube Label

    head &
    shoulders
    PYRITHIONE ZINC DANDRUFF CONDITIONER

    SHEA BUTTER

    HAIR & SCALP

    CONDITIONER

    Rich moisture

    for scalp & hair

    FOR CURLY TO COILY HAIR

    10.9 FL OZ
    (325 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS SHEA BUTTER HAIR AND SCALP CONDITIONER 
    pyrithione zinc oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-669
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-669-32325 mL in 1 TUBE; Type 0: Not a Combination Product02/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03202/01/2023
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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