Label: EQUATE EVERYDAY CLEAN GENTLE DANDRUFF- 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 February 9, 2018

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  • Active ingredient

    Pyrithione Zinc 1%

    Purpose

    Anti-dandruff

  • Uses

    • to help 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 out of reach of children.

    • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
  • Directions

    • For best results, use at least twice a week or as directed by a doctor.
    • wet hair, massage onto scalp and rinse.
    • repeat if desired.
  • Inactive ingredient

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

  • Questions or comments?

    1-888-287-1915

  • Label copy

    image of the label

  • INGREDIENTS AND APPEARANCE
    EQUATE EVERYDAY CLEAN GENTLE DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-087
    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)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    LAURETH-4 (UNII: 6HQ855798J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-087-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2018
    2NDC:49035-087-14420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H02/08/2018
    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(49035-087)
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