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

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DANDRUFF (PYRTHIONE ZINC) SHAMPOO [VI-JON, INC]
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NDC 11344-475-15
Set ID f22d096b-e411-48e0-9c6b-a0c653cbc67d
Category HUMAN OTC DRUG LABEL
Packager Vi-Jon, Inc
Generic Name
Product Class
Product Number
Application Number PART358H
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  • claims

    YOUR HAIR NEEDS TO REFUEL TOO: WHEN YOU'RE FEELING EXTRA DRY, GIVE YOURSELF A WIN WITH HYDRATE & RECOVER.

  • Active ingredients

    pyrithione zinc 1%

  • Purpose

    Anti-dandruff

  • 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, Prunus amygdalus dulcis (sweet almond) oil, citric acid, sodium hydroxide

  • adverse reaction

    Distributed by: Vi-Jon, LLC

    8515 Page Ave, St. Louis, MO 63114

    475.000/475AA

  • principal display panel

    NEW

    VICTORY

    DANDRUFF

    SHAMPOO

    PYRITHIONE ZINC

    HELPS

    RECOVER

    OPTIMAL SCALP

    HYDRATION

    HELPS RELIEVE

    SCALP DRYNESS,

    ITCH, FLAKES

    & IRRITATION

    HYDRATE

    & RECOVER

    14.2 FL OZ (420 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrthione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-475
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    pyrithione zinc (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) pyrithione zinc1 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)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-475-15420 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, Inc (150931459)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC150931459manufacture(11344-475)
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