Label: BEING WELL BODY DRY SCALP CARE- pyrithione zinc shampoo 

  • NDC Code(s): 46994-511-14, 46994-511-23
  • Packager: Save-A-Lot Food Stores Ltd
  • 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 03/13

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  • ACTIVE INGREDIENT

    Active Ingredient
    Pyrithione Zinc 1%

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  • PURPOSE

    Purpose
    Anti-Dandruff

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  • INDICATIONS & USAGE

    Uses • helps eliminate irritation and flaking associated with dandruff.

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  • WARNINGS

    Warnings
    For external use only
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  • WHEN USING

    When using this product •avoid contact with eyes • if contact occurs, rinse eyes with plenty of water.

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  • STOP USE

    Stop use and ask a doctor if condition does not improve or worsen after regular use of this product as directed

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  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs 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 •wet hair •lather •massage onto scalp •rinse well •repeat if desired •for best results use regularly

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  • INACTIVE INGREDIENT

    Inactive Ingredients acrylates copolymer, benzyl alcohol, cetyl alcohol, citric acid, cocamide MEA, dimethicone, fragrance, glycol distearate, guar hydroxypropyltrimonium chloride, methylchloroisothiazolinone, methylisothiazolinone, prunus amygdalus dulcis (sweet almond) oil, sodium chloride, sodium laureth sulfate, sodium lauryl sulfate, triethanolamine, water, zinc sulfate 

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  • INGREDIENTS AND APPEARANCE
    BEING WELL BODY  DRY SCALP CARE
    pyrithione zinc shampoo
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:46994-511
    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
    BENZYL ALCOHOL  
    CETYL ALCOHOL  
    CITRIC ACID MONOHYDRATE  
    COCO MONOETHANOLAMIDE  
    DIMETHICONE  
    GLYCOL DISTEARATE  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)  
    METHYLCHLOROISOTHIAZOLINONE  
    METHYLISOTHIAZOLINONE  
    ALMOND OIL  
    SODIUM CHLORIDE  
    SODIUM LAURETH SULFATE  
    SODIUM LAURYL SULFATE  
    TROLAMINE  
    WATER  
    ZINC SULFATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46994-511-23 700 mL in 1 BOTTLE, PLASTIC
    2 NDC:46994-511-14 420 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 03/25/2013
    Labeler - Save-A-Lot Food Stores Ltd (095484572)
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