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Dandruff (Topco Associates)

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SHAMPOO 420 mL in 1 BOTTLE, PLASTIC (36800-309-15) Label Information

Complete Dandruff Information

  • SPL UNCLASSIFIED SECTION

    Dandruff Care for Great Looking Hair
    Top Care Dandruff Shampoo Fresh Mint formula
    helps relieve scalp dryness, itch, irritation and
    helps prevent flakes, for clean manageable hair every day

  • Active Ingredient

    Active ingredient
    Pyritione zinc 1%

    purpose Purpose
    Anti-dandruff

  • Use

    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 leat twice a week or as directed by a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients water, sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, zinc carbonate, glycol distearate, fragrance.,
    amodimethicone, cetyl alcohol, guar hydroxypropyltrimonium chloride, menthol, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonioum laureth sulfate, benzyl alcohol, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfante, trideceth-12, cetrimonium chloride, sodium hydroxide, yellow 10, blue1, red 4


  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by
    Procter + Gamble, distributor of Head + Shoulders refresh pyrithione zinc Dandruff Shampoo


  • ADVERSE REACTIONS

      DISTRIBUTED BY TOPCO ASSOCIATES LLC
    7711 GROSS POINT ROAD, SKOKIE, IL 60077
    QUESTIONS? 1-888-423-0139

  • PRINCIPAL DISPLAY PANEL

    TOPCARE
    GENTLE
    dandruff
    shampoo
    with pyrithione zinc
    a cool refreshing
    sensation and
    hair is left clean and
    manageable
    FRESH MINT
    COMPARE TO
    HEAD + SHOULDERS
    14.2 FL OZ
    (420 mL)
    image of principal display panel

  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-309
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    MENTHOL (UNII: L7T10EIP3A)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    TRIDECETH-12 (UNII: YFY3KG5Y7O)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:36800-309-15 420 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 02/10/2011
    Labeler - Topco Associates (006935977)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 088520668 manufacture(36800-309)