Label: PYRITHIONE ZINC- 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 April 4, 2018

If you are a consumer or patient please visit this version.

  • Claims

    LET'S BE HONEST, THAT SHAMPOO YOU'RE USING NOW-IT DOESN'T REALLY SUIT YOU, BE A LEGEND

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  • Active ingredient

    Pyrithione zinc 1%

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  • Purpose

    Anti-dandruff

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  • Use

    helps prevent recurrence of flaking and itching associated with dandruff

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  • Warnings

    For external use only

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  • When using this product

    • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water
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  • Stop use and ask a doctor if

    • condition worsens or does not improve after regular use as directed
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  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • 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
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  • 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, blue 1, green 3

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  • SPL UNCLASSIFIED SECTION

    Distributed by: Vi-Jon, Inc.

    8515 Page Ave, St. Louis, MO 63114

    928.000/928.AA

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  • principal display panel

    NEW

    VICTORY DANDRUFF SHAMPOO +CONDITIONER

    PYRITHIONE ZINC

    A POWERFUL TWIST ON THE STANDARD HELPS RELIEVE SCALP DRYNESS ITCH, FLAKES & IRRITATION

    2-in-1

    LEGENDARY

    FOR MEN

    14.2 FL OZ ( 420 mL)

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  • INGREDIENTS AND APPEARANCE
    PYRITHIONE ZINC 
    pyrithione zinc shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11344-928
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    pyrithione zinc (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) pyrithione zinc 10.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11344-928-15 420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/17/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 06/17/2016
    Labeler - Vi-Jon, Inc (150931459)
    Registrant - Vi-Jon, Inc (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon, Inc 150931459 manufacture(11344-928)
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