WECARE ANTI-DANDRUFF (ANTIDANDRUFF SHAMPOO) LIQUID [DYNAREX CORPORATION]

WECARE ANTI-DANDRUFF (ANTIDANDRUFF SHAMPOO) LIQUID [DYNAREX CORPORATION]
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NDC 67777-139-80
Set ID 7fad58a3-5537-f87a-e053-2991aa0a7cdb
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART358H
  • 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.

    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

    Water, Sodium Laureth Sulfate, Cocamide MEA, Cocamidopropyl Betaine, Sodium Chloride, Glycol Distearate, Acrylates Copolymer, Coco-Glucoside, Styrene/Acrylates Copolymer, Dimethiconol, Glyceryl Oleate, Polyquaternium-10, Citric Acid, TEA-dodecyl-benzene-sulfonate, Sodium Hydroxide, Benzyl Alcohol, Sodium Benzoate, Methylchloroisothiazolinone, Methylisothiazolinone, Amyl Cinnamal, Benzyl Salicylate, CI42090

  • 1398 Label

    1398 Dandruff Shampoo PDP

  • 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 g
    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
    1335 g 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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