DANDRUFF (PYRTHIONE ZINC) SHAMPOO [VI-JON, INC]

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DANDRUFF (PYRTHIONE ZINC) SHAMPOO [VI-JON, INC]
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NDC 11344-443-15
Set ID 5d6481d1-f4b3-421b-9844-a94b42d4740f
Category HUMAN OTC DRUG LABEL
Packager Vi-Jon, LLC
Generic Name
Product Class
Product Number
Application Number PART358H
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  • claims

    IT'S A HAT-TRICK FOR YOUR MORNING ROUTINE: REDUCED DANDRUFF, CLEANED/CONDITIONED HAIR- WITH A CLEAN MANGO SCENT.

  • Active ingredients

    pyrithione zinc 1%

  • Purpose

    Antidandruff

  • Use

    helps prevent recurrence of flaking and itching associated with dandruff

  • 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.

  • Directions

    • shake well before use
    • 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 ingredients

    water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylisothiazolinone, methylchloroisothiazolinone, citric acid, sodium hydroxide, yellow 5, red 40

  • adverse reaction

    Distributed by: Vi-Jon, LLC

    8515 Page Ave, St. Louis, MO 63114

    Get a win for the environment by recycling this package

  • principal display panel

    NEW

    VICTORY

    DANDRUFF SHAMPOO +

    CONDITIONER

    PYRITHIONE ZINC

    INDULGE,

    NOURISH &

    CLEAN YOUR

    SCALP WITH A

    MANGO SCENT

    HELPS RELIEVE

    SCALP DRYNESS

    ITCH, FLAKES

    & IRRITATION

    2-IN-1

    TRIPLE

    TREAT

    14.2 FL OZ (420 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrthione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-443
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    pyrithione zinc (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) pyrithione zinc10.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-443-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/17/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/17/2016
    Labeler - Vi-Jon, LLC (150931459)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC150931459manufacture(11344-443)
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