Label: DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 55319-612-15
  • Packager: Family Dollar Services, Inc.
  • 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 03/15

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

  • Claims

    Multiple benefit formula to help:

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

    Pyrithion 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 manimum 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 chloried, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5

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  • disclaimer

    This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders green apple 2 in 1 Dandruff Shampoo & conditioner

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  • Adverse reaction

    Not 100% satisfied?

    Return package and unused product within 30 days to any Family Dollar store for a refund ( with receipt) or exchange.

    DISTRIBUTED BY:

    FAMILY DOLLAR SERVICES, INC.

    10401 MONROE ROAD

    MATTHEWS NC 28105

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  • Principal Display Panel

    FAMILY

    DOLLAR

    100% SATISFACTION

    GUARANTEED

    OR YOUR MONEY BACK

    Compare to

    HEAD &

    SHOULDERS

    DANDRUFF

    SHAMPOO

    pyrithione zinc

    dandruff shampoo plus conditioner

    2 in 1

    clean apple

    helps relieve scalp dryness, itcing,

    and light flaking while keeping hair

    clean, soft, and healthy looking

    14.2 FL OZ (420 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:55319-612
    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 1 g  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)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55319-612-15 420 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 12/18/2012
    Labeler - Family Dollar Services, Inc. (024472631)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(55319-612)
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