Label: HEAD AND SHOULDERS GROOMING- pyrithione zinc paste

  • 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 July 21, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione zinc .1%

  • Purpose

    Anti-dandruff

  • Uses

    Use to help eliminate recurrence of itching, flaking, and irritation 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

    • apply to affected areas one to four times daily or as directed by doctor
    • apply a small amount of product in hands and work through damp or dry hair from root to tip and style as desired.
  • Inactive ingredients

    Water, ceresin, cetearyl alcohol, petrolatum, cetyl alcohol, copernicia cerifera (carnauba) wax, octylacrylamide/acrylates/butylaminoethyl methacrylate copolymer, ceteareth-25, PVP, dicaprylyl maleate, mineral oil, aminomethyl propanol, carbomer, benzyl alcohol, 1,2-hexanediol, caprylyl glycol, fragrance, panthenol, niacinamide, caramel.

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 85 g Jar Label

    head &

    shoulders     ®

    pyrithione zinc dandruff paste

    GROOMING

    PASTE

    MEDIUM HOLD / MATTE FINISH

    NET WT. 3 OZ (85 g)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS GROOMING 
    pyrithione zinc paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-480
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    DIOCTYL MALEATE (UNII: OD88G8439L)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    POVIDONE K12 (UNII: 333AG72FWJ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CARAMEL (UNII: T9D99G2B1R)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-480-8585 g in 1 JAR; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/01/2020
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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