Label: 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 August 2, 2012

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  • ACTIVE INGREDIENT

    Active ingredient
    Pyrithione zinc

    Purpose
    Anti-dandruff
  • INDICATIONS & USAGE

    Use helps prevent recurrence of flaking and itching associated with dandruff
  • WARNINGS

    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 Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

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

    Inactive ingredients water, sodium laureth sulfate, sodium lauryl sulfate, amodimethicone, cocamide MEA, zinc carbonate, glycol distearate,
    sodium hydroxypropyltrimonium chloride, magnesium sulfate, sodium chloride, sodium benzoate, magnesium carbonate hydroxide,
    benzyl alcohol, prunus amygdalus dulcis (sweet almond)oil, trideceth-12, cetrimonium chloride, sodium hydroxide,
    methylchloroisothiazolinone, methylisothiazolinone
  • QUESTIONS

    Questions?  Call: 1-888-287-1915
  • ADVERSE REACTIONS

    Satisfaction guaranteed - Or we'll replace it or give you your money back.  For questions or comments or to report an undesired reaction or side effect please call 1-888-287-1915.
    Distributed by: Wal-Mart Stores, Inc.,
    Bentonville, AR 72716
    Wal-Mart Stores, Inc
  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by Procter + Gamble, distributor of Head + Shoulders dry scalp care dandruff shampoo.
  • PRINCIPAL DISPLAY PANEL

    Equate
    Compare to
    Head +
    Shoulders
    Active
    Ingredient
    Dry Scalp
    Care
    Pyrithione Zinc
    Dandruff
    Shampoo
    Moistruizes to Releive
    Dry Scalp and Itch
    Helps Improve Hair
    and Scalp Health
    23.7 FL OZ (700 mL)
    image of principal display panel
  • INGREDIENTS AND APPEARANCE
    DANDRUFF  
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-281
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    TRIDECETH-12 (UNII: YFY3KG5Y7O)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-281-150.420 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/05/2009
    Labeler - Wal-Mart Stores, Inc (051957769)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(49035-281)
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