Label: DANDRUFF- pyrithione zinc lotion/shampoo 

  • Label RSS
  • NDC Code(s): 41520-311-15
  • Packager: American Sales Company
  • 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 02/13

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

  • SPL UNCLASSIFIED SECTION

    Dandruff Care for Great Looking Hair
    This product helps relieve scalp dryness,
    itch, irritation and helps prevent flakes.
    Clean Manageable Hair for Everyday
    • Dual Formula cleans and conditions hair in
    one easy step
    • Gentle and pH balanced for everyday use
    -even for permed or colored-treated hair

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  • ACTIVE INGREDIENT

    Active Ingredient
    Pyrithione zinc 1%

    Purpose
    Anti-dandruff
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  • INDICATIONS & USAGE

    Use helps prevent recurrence of flaking and itching associated with dandruff
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  • WARNINGS

    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.
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  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

    Inactive ingredients water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, cocamidopropyl betaine, fragrance, amodimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

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  • ADVERSE REACTIONS

    Distributed by: American Sales company
    4201 Walden Avenue, Lancaster, NY 14086
    1-877-846-9949

    Quality guaranteed or your mone back

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  • Principal Display Panel

    CAREONE

    everyday clean 12 in 1

    Dandruff

    shampll pls conditioner

    for normal hair

    pyrithione zinc

    14.2 fl 0z (420 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrithione zinc lotion/shampoo
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-311
    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 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM LAURYL SULFATE  
    SODIUM LAURETH SULFATE  
    GLYCOL DISTEARATE  
    SODIUM CHLORIDE  
    ZINC CARBONATE  
    SODIUM XYLENESULFONATE  
    COCAMIDOPROPYL BETAINE  
    AMODIMETHICONE (800 CST)  
    SODIUM BENZOATE  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)  
    MAGNESIUM CARBONATE HYDROXIDE  
    METHYLCHLOROISOTHIAZOLINONE  
    METHYLISOTHIAZOLINONE  
    FD&C BLUE NO. 1  
    D&C RED NO. 33  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-311-15 420 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 07/09/2004
    Labeler - American Sales Company (809183973)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(41520-311)
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