Label: ADVANCED SEBORRHEIC DERMATITIS THERAPY- pyrithione zinc soap

  • Category: HUMAN OTC DRUG LABEL

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 June 14, 2016

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  • Active Ingredient

    Pyrithione Zinc 2%

  • Purpose

    Dandruff/Seborrheic Dermatitis

  • Use

    For relief of skin itching, flaking, and scaling associated with dandruff and seborrheic dermatitis

  • Warnings

    For external use only

  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of the reach of children.
    • If swallowed, get medical help or contact a Poison Control Center immediately.
  • Directions

    ■ Use on affected areas in place of your regular soap
    ■ For best results use at least twice a week or as directed by a doctor

  • When using this product

    ■ avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if

    Stop use and ask a doctor if ■ condition worsens, or does not improve after regular use of this product as directed.

  • Ask a doctor before use

    Ask a doctor before use if you have seborrheic dermatitis that covers a large portion of the body.

  • INACTIVE INGREDIENT

    Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Palmitic Acid, Titanium Dioxide (CI 77891), Sodium Chloride, Jojoba Esters, Tetrasodium EDTA, Tetrasodium Etidronate, Iron Oxides (CI 77499), Ferric Ferrocyanide, Green 5 (CI 61570),
    Yellow 10 (CI 47005)

  • Questions?

    www.CVS.com

    1-800-SHOP CVS

  • Label

    Box

  • INGREDIENTS AND APPEARANCE
    ADVANCED SEBORRHEIC DERMATITIS THERAPY 
    pyrithione zinc soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-343
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC FERROCYANIDE (UNII: TLE294X33A)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-343-78119 g in 1 BOX; Type 0: Not a Combination Product06/10/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/10/2016
    Labeler - CVS Pharmacy, Inc. (062312574)
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