Label: WALMART- pyrithione zinc lotion/shampoo

  • 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 November 4, 2022

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  • ACTIVE INGREDIENT

    Pyrithione Zinc

  • PURPOSE

    For the relief of itching, redness and flaking associated with dandruff

  • WARNINGS

    For External use

    on children under 2 years of age, unless directed by a doctor.

    Stop use and ask a doctor if condition worsens or does not improve after regular use of this product
    as directed.

    avoid contact with eyes.
    If contact occurs, rinse eyes thoroughly with water.

    If swallowed, call a poison control centre or get medical help right away.

  • DOSAGE & ADMINISTRATION

    • Adults and children 2 years and older.

    • Wet Scalp. Apply evenly to scalp, leave on for several minutes, and then rinse off. Use at least twice per week or as

    directed by a doctor or pharmacist.

  • INDICATIONS & USAGE

    Relieves itching , redness and flakes associated with Dandruff.

  • INACTIVE INGREDIENT

    Water, Sodium Laureth Sulfate, Acrylates Copolymer, Cocamidopropyl Betaine, Dimethicone,
    Sodium Chloride, Glycol Distearate, Fragrance, Laureth-4, Polyquaternium-113, Sodium Hydroxide,
    Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1(CI 42090), Red 33 (CI 17200).

  • STORAGE AND HANDLING

    Store at room temperature

  • PRINCIPAL DISPLAY PANEL

    950 mL

  • INGREDIENTS AND APPEARANCE
    WALMART 
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-897
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    LAURETH-4 (UNII: 6HQ855798J)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    ACID RED 337 FREE ACID (UNII: Z9C910400Y)  
    DIRECT BLUE 1 (UNII: 8NN34MAQ6H)  
    POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-897-95950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03211/04/2022
    Labeler - Wal-Mart Stores, Inc (051957769)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc201901209manufacture(79903-897)
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