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 June 18, 2012

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  • SPL UNCLASSIFIED SECTION

    Dry Scalp Dandruff Care
    for Great Looking Hair
    With moisturizers, it soothes the scalp while
    cleaning ad conditioning the dandruff.
  • 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 the 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
  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by
    Procter + Gamble, distributor of Head + Shoulders
  • ADVERSE REACTIONS

    DISTRIBUTED BY
    WAKFERN FOOD CORPORATION
    5000 RIVERSIDE DRIVE
    KEASBEY, NJ 08832
    1-800-SHOPRITE
    www.shoprite.com
  • PRINCIPAL DISPLAY PANEL

    COMPARE TO ACTIVE INGREDIENT
    IN HEAD + SHOULDERS
    Shop Rite
    DANDRUFF
    Shampoo
    Pyrithione Zinc
    DRY SCALP FORMULA
    moisturizes and helps
    prevent flaking + itching
    14.2 FL OZ
    (420 mL)
    image of principal display panel
  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41190-281
    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)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41190-281-150.420 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H05/11/1992
    Labeler - Wakfern Food Corporation (069722418)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(41190-281)
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