Label: PYRITHIONE ZINC 0.5 DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 52000-416-12
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 29, 2024

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  • Drug Facts

  • Active Ingredient:

    Pyrithione zinc 0.5% W/V

  • Purpose:

    Anti-dandruff

  • Uses:

    Helps prevent recurrence of flaking and itching associated with dandruff.

  • Directions:

    Wet hair, massage onto scalp, rinse. Repeat if desired. For best results use at least twice a week or as directed by a doctor.

  • Other Information:

    Store at 20°C to 25°C (68°F to 77°F)

  • Inactive Ingredients:

    Water, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Cocamide Mea, Acrylated Co Polymer, Glycerin, Fragrance, Citric Acid, Disodium Edta, Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, Guar Hydroxypropyltrimonium Chloride, Glycol Distearate, Menthol, Fd & C Blue No.1

  • 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. If swallowed, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children.

  • SPL UNCLASSIFIED SECTION

    ALL HAIR TYPES

    Helps to relieve itching, dryness and flakes

    Distributed by:
    Universal Distribution Center LLC
    96 Distribution Boulevard, Edison, NJ 08817
    www.universaldc.com

    Made in India                                                                           

  • Packaging

    Anti-Dandruff

  • INGREDIENTS AND APPEARANCE
    PYRITHIONE ZINC 0.5 DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-416
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: B16G315W7A)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-416-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03205/17/2024
    Labeler - Universal Distribution Center LLC (019180459)
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