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 01/13

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

  • Claims

    Dandruff Care for Great Looking Hair

    This product helps prevent the recurrence of flaking and itchng associated with dandruff

    • Double the benefits with both cleansing and conditioning for the scalp and hair
    • Gentle and pH balanced for everyday use- even on permed or color treated hair
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  • Active ingredient

    Active ingredient

    Pyrithion zinc 1%

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  • Purpose

    Purpose

    Anti-dandruff

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  • use

    Use helps prevent recurrence of flaking and itching associated with dandruff

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  • Warnings

    Warnings

    For external use only

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  • When using this product

    When using this product

    • do not get into eyes. If contact occurs, rinse eyes thoroughly with water.
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  • Stop use

    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

    Keep out of reach of children. If swallowed, get medical help ro contact a Poison Control Center right away.

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  • Directions

    Directions

    • shake well
    • for manimum dandruff control, use every tme 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

    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, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5, citric acid

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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

    pyrithone zinc

    dandruff shampoo plus conditioner

    2 in 1

    clean apple

    helps relieve scalp dryness, itching,

    and algith 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 LABEL Item Code (Source) NDC:55319-612
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 1 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM LAURYL SULFATE  
    SODIUM LAURETH SULFATE  
    GLYCOL DISTEARATE  
    SODIUM CHLORIDE  
    ZINC CARBONATE  
    SODIUM XYLENESULFONATE  
    AMODIMETHICONE (800 CST)  
    COCAMIDOPROPYL BETAINE  
    SODIUM BENZOATE  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)  
    MAGNESIUM CARBONATE HYDROXIDE  
    METHYLCHLOROISOTHIAZOLINONE  
    FD&C BLUE NO. 1  
    FD&C YELLOW NO. 5  
    CITRIC ACID MONOHYDRATE  
    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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