Label: 2IN1 DANDRUFF AND CONDITIONER- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL

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 July 16, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient
    Pyrithione zinc 1%

  • PURPOSE

    Purpose
    Anti-dandruff
  • INDICATIONS & USAGE

    Uses • helps to treat flakes, itch, irritation, oilness or dryness caused by 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, •squeeze small amount into palm •lather, •rinse well

  • INACTIVE INGREDIENT

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

    package label

    image of package label

  • INGREDIENTS AND APPEARANCE
    2IN1  DANDRUFF AND CONDITIONER
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-154
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-154-23700 mL in 1 BOTTLE, PLASTIC
    2NDC:55319-154-14420 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/15/2012
    Labeler - Family Dollar (024472631)
    Establishment
    NameAddressID/FEIBusiness Operations
    Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil566220234manufacture(55319-154)
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