Label: EQUATE- pyrithione zinc 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 August 31, 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

    Stop 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 the product.

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

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years and older. Shake well. Apply evenly to scalp. leave on for several mimnutes and then rinse off. Use at least twice per week or as directed by a doctor or pharmacist.

  • STORAGE AND HANDLING

    Store at room temperature

  • INACTIVE INGREDIENT

    Water, Stearyl Alcohol, Behentrimonium Chloride, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Fragrance, PPG-3 Benzyl Ether Ethylhexanoate, Lauryl PEG/PPG-18/18 Methicone, Hydroxyethylcellulose, Sodium Hydroxide, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone

  • INDICATIONS & USAGE

    Relieves itching , redness and flakes associated with Dandruff.

  • PRINCIPAL DISPLAY PANEL

    700 ml

  • INGREDIENTS AND APPEARANCE
    EQUATE 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-900
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC300 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    PPG-3 BENZYL ETHER ETHYLHEXANOATE (UNII: 3N703GY99W)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-900-24700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03208/31/2022
    Labeler - Wal-Mart Stores, Inc (051957769)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(79903-900)
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