Label: BEING WELL BODY 2IN1 DANDRUFF AND CONDITIONER- pyrithione zinc shampoo

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 20, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient
    Pyrithione Zinc 1%

  • PURPOSE

    Purpose

    Anti-Dandruff 

  • INDICATIONS & USAGE

    Uses • helps eliminate irritation and flaking associated with dandruff.

  • WARNINGS

    Warnings
    For external use only
  • WHEN USING

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

  • STOP USE

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

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions •wet hair •lather •massage onto scalp •rinse well •repeat if desired •for best results use regularly

  • INACTIVE INGREDIENT

    Inactive Ingredients 

    Inactive ingredientsacrylates copolymer, benzyl alcohol, cetyl alcohol, cocamide MEA, dimethicone, FDC blue no.1, fragrance, glycol distearate, methylchloroisothiazolinone, methylisothiazolinone, polyquaterinum-10, sodium chloride, sodium laureth sulfate, sodium lauryl sulfate, triethanolamine, water, zinc sulfate

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BEING WELL BODY  2IN1 DANDRUFF AND CONDITIONER
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46994-510
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46994-510-23700 mL in 1 BOTTLE, PLASTIC
    2NDC:46994-510-14420 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H03/25/2013
    Labeler - Save-A-Lot Food Stores Ltd (095484572)
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