Label: 2 IN 1- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL

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 December 26, 2018

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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 ro contact a Poison Control Center right away.

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  • 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
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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, citric acid, Eucalyptus globulus leaf extract, methylchloroisothiazolinone, methylisothiazolinone

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  • Questions?

    Call 1-888-287-1915

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  • SPL UNCLASSIFIED SECTION

    Itchy Scalp Control
    2 in 1 Pyritione Zinc
    Dandruff Shampoo & Conditioner

    *This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders Itchy Scalp Care

    Made in the USA with imported parts

    Distributed by Wal-Mart Stores, Inc.,
    Bentonville, AR 72716

    Satisfaction guaranteed- for questions or comments please call 1-888-1915

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  • Principal display panel

    equate

    Compare to Head & Shoulders Active Ingredient*

    Itchy Scalp Control 2 in 1

    Pyrithione Zinc Dandruff Shampoo & Conditioner

    • Moisturizes to relieve dry scalp and itch
    • Helps relieve itching and flaking associated with dandruff

    23.7 FL OZ (700 mL)

    image description

    566.001/566AC

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  • INGREDIENTS AND APPEARANCE
    2 IN 1 
    pyrithione zinc shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-836
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 10.3 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)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-836-35 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/12/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 07/12/2012
    Labeler - Wal-Mart Stores, Inc (051957769)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(49035-836)
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