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

DANDRUFF (PYRITHIONE ZINC) SHAMPOO [VI-JON, INC]
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NDC 11344-253-15, 11344-253-21, 11344-253-35
Set ID 2a196877-c122-447a-abd5-2b18d7921f57
Category HUMAN OTC DRUG LABEL
Packager Vi-Jon, LLC
Generic Name
Product Class
Product Number
Application Number PART358H
  • Active ingredient

    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
    • 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, sodim benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

  • SPL UNCLASSIFIED SECTION

    Multiple benefit formula to help:

    • Fight dry scalp
    • Calm itch
    • Relieve irritation
    • Soothe and reduce redness
    • Reduce oiliness
    • Prevent flakes
    • Leave hair healthy looking

    *This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders Pyrithione Zinc Dandruff Shampoo + Conditioner Old Spice Men 2 in 1.

    Manufactured by:  Vi-Jon, Inc.

    St. Louis, MO 63114

    Questions or Comments? 1-888-593-0593

    Made in the USA with US and foreign parts.

  • principal display panel

    Mountain falls

    *Compare to Head & Shoulders

    Helps prevent flakes

    + conditioner 

    Leaves hair clean and managable

    pH balanced formula

    2 in 1 Dandruff Shampoo with pyrithione zinc

    smooth spice

    23.7 FL OZ (700 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-253
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 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)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-253-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2016
    2NDC:11344-253-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2016
    3NDC:11344-253-2188 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2016
    4NDC:11344-253-35700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H05/31/2016
    Labeler - Vi-Jon, LLC (150931459)
    Registrant - Vi-Jon, LLC (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(11344-253)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(11344-253)

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