Label: DANDRUFF - pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/15

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

  • claims

    Dry Scalp Control

    Pyrithione Zinc

    Dandruff Shampoo

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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
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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
    • 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,glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, Prunus amygdalus dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone

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  • Questions

    Call: 1-888-287-1915

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  • guaranteed

    Satisfaction guaranteed - For questions or comments please call 1-888-287-1915

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  • adverse reactions

    Distributed by: Wal-Mart Stores, Inc.

    Bentonville, AR 72716

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  • Disclaimer

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

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  • Principal display panel

    equate

    Compare to Head & Shoulders Active Ingredient

    Dry Scalp

    Control

    Pyrithione Zinc

    Dandruff Shampoo

    • Moisturizes to relieve dry scalp and itch
    • Helps improve hair and scalp health

    23.7 FL OZ (700 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    DANDRUFF  
    pyrithione zinc shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-281
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 10 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)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-281-35 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 01/05/2009
    Labeler - Wal-Mart Stores, Inc (051957769)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 088520668 manufacture(49035-281)
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