2IN1 DANDRUFF AND CONDITIONER (PYRITHIONE ZINC) SHAMPOO [FAMILY DOLLAR]

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2IN1 DANDRUFF AND CONDITIONER (PYRITHIONE ZINC) SHAMPOO [FAMILY DOLLAR]
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NDC 55319-154-14, 55319-154-23
Set ID 335ba153-f1d0-4ee3-9cee-604d85e86187
Category HUMAN OTC DRUG LABEL
Packager Family Dollar
Generic Name
Product Class
Product Number
Application Number PART358H
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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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