Label: WECARE ANTI-DANDRUFF- antidandruff shampoo liquid

  • NDC Code(s): 67777-139-80, 67777-139-81
  • Packager: Dynarex Corporation
  • 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 3, 2023

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  • Active ingredient

    Pyrithione Zinc 0.5%

  • Purpose

    Anti-Dandruff

  • Use

    Helps eliminate irritation and flaking associated with dandruff

  • Warnings

    For External Use Only

    When using this product

    • Avoid contact with eyes
    • If contact occurs, rinse eyes with plenty of water

    Stop use and ask a doctor if

    condition does not improve or worsens after regular use of this product as directed.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • wet hair
    • lather
    • massage onto scalp
    • rinse well
    • repeat if desired
    • for best results, use regularly
  • Inactive ingredients

    Acrylates Copolymer, Amyl Cinnamal, Benzyl Alcohol, Benzyl Salicylate, CI 42090, Citric Acid, Cocamide MEA, Cocamidopropyl Betaine, Coco-Glucoside, Dimethiconol, Glyceryl Oleate, Glycol Distearate, Methylchloroisothiazolinone, Methylisothiazolinone, Perfume, Polyquaternium-10, Sodium Benzoate, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Styrene/Acrylamide Copolymer, TEA-Dodecylbenzenesulfonate, Water

  • Label

    1398-IN-MASTERDandruff Shampoo

  • INGREDIENTS AND APPEARANCE
    WECARE ANTI-DANDRUFF 
    antidandruff shampoo liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-139
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC5 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    WATER (UNII: 059QF0KO0R)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-139-8012 in 1 CASE10/11/2018
    1NDC:67777-139-81355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/11/2018
    Labeler - Dynarex Corporation (008124539)
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