Label: SIMPLY BODYCARE 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 April 1, 2023

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  • Active ingredient

    Pyrithione zinc 0.5%

  • Purpose

    Anti-dandruff

  • Use

    helps prevent recurrence of flaking and itching associated with dandruff.

  • Warnings

    For external use only.

    When using this product do not get into 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 as directed.

  • Keep out of reach of children.

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

  • Directions

    • shake well • wet hair • massage shampoo into scalp • rinse • repeat if desired • for best results, use at least twice a week or as directed by a doctor • for maximum dandruff control, use every time you shampoo.

  • Inactive ingredients

    Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Cocamide MEA, Styrene/Acrylates Copolymer, Guar Hydroxypropyltrimonium Chloride, Sodium Citrate, Fragrance, Sodium Chloride, Dimethicone, Methylisothiazolinone, Iodopropynyl Butylcarbamate, FD&C Blue No.1.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SIMPLY BODYCARE DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58037-205
    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
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58037-205-01400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03204/01/2023
    Labeler - New Pride Corp (884264198)
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