Label: PERSONAL CARE DRY SCALP- 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 12, 2018

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  • Active ingredient

    Pyrithione zinc 1%

  • Purpose

    Anti-dandruff

  • Use

    helps to treat flakes, itch, irritation, oilness or dryness caused by 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

    ■ if condition does not improve or worsen 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 ■ squeeze small amount into palm ■ lather ■ rinse well ■ for best results use at least twice a week or as directed by a doctor

  • Inactive ingredients

    water (aqua), sodium laureth sulfate sodium lauryl sulfate, cocamide MEA,sodium chloride, dimethicone, cetyl alcohol, polyquaternium-10, glycol distearate, disodium EDTA, cocamidopropyl betaine, DMDM hydantoin, citric acid, fragrance, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone,FD&C Blue No. 1

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE  DRY SCALP
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-047
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72133-047-13400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H04/09/2018
    Labeler - Delta Brands & Products LLC (080999173)
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