Label: PYRITHIONE ZINC liquid

  • 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 July 16, 2010

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  • ACTIVE INGREDIENT



    Active ingredient                            Purpose
    Pyrithione Zinc (1%)..................................Anti-dandruff Anti-seborrheic dermatitis
  • PURPOSE



    Active ingredient                          Purpose

    Pyrithione Zinc (1%)...............................Anti-dandruff Anti-seborrheic dermatitis

    Use Controls the symptoms of dandruff and seborrheic dermatitis
  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. If swallowed, get medical help
    or contact a Poison Control Center right away.
  • INDICATIONS & USAGE



    Directions - for best results, use at least twice a week or as directed by a doctor.

    - Wet hair thoroughly. - Massage a liberal amount into your scalp.

    - Leave lather on scalp for several minutes - Rinse and repeat.

  • WARNINGS

    Warnings For external use only.


    Ask a doctor before use if you have     a condition that covers a large area of the body.

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


  • DOSAGE & ADMINISTRATION



    Directions - for best results, use at least twice a week or as directed by a doctor.

    - Wet hair thoroughly. - Massage a liberal amount into your scalp.

    - Leave lather on scalp for several minutes - Rinse and repeat.
  • INACTIVE INGREDIENT



    Inactive Ingredients Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate,
    Cocoamphodlacatate, Glycol Stearate, Divinyidimethicone.Dimethicone Copolymer,
    C12-13 Pareth-3, C12-13 Pareth-23, Hydrolyzed Wheat Protein PG-Propyl Silanetriol,
    BHT, Tocopharyl Acetate, Amodimethicone, Castor Isostearate Succinate,
    Guar Hydroxypropyltrimonium Chloride, Sodium Methyl Cocoyl Tauratem,
    Methylparaben, Propylparaben, Acrylates Copolymer, Dichlorophenyl Inidazoidioxoian,
    Blue 1, Fragrance

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    PYRITHIONE ZINC 
    pyrithione zinc liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC29 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CARBOMER 934 (UNII: Z135WT9208)  
    SODIUM LAURETH-2 SULFATE (UNII: ZZQ59TY3KG)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIMETHYL OCTADECYL AMMONIUM CHLORIDE (UNII: CZ70647U92)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-016-10250 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/16/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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