2IN1 DANDRUFF AND CONDITIONER (PYRITHIONE ZINC) SHAMPOO [DELTA KOZMETIK SANAYI VE TICARET-SELIM YESIL]

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2IN1 DANDRUFF AND CONDITIONER (PYRITHIONE ZINC) SHAMPOO [DELTA KOZMETIK SANAYI VE TICARET-SELIM YESIL]
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NDC 51357-001-14, 51357-001-23
Set ID 8a625853-4ec6-489a-ada0-fa3dd3840bb1
Category HUMAN OTC DRUG LABEL
Packager Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil
Generic Name
Product Class
Product Number
Application Number PART358H
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  • Active Ingredient

    Pyrithione zinc 1%

  • Purpose

    Anti-dandruff

  • Uses

    • helps to treat flakes, itch, irritation, oilness or dryness caused by dandruff.

  • Warnings

    For external use only

  • When using this product

     •avoid contact with eyes • if contact occurs, rinse eyes with plenty of water.

  • Stop use and ask a doctor if

    condition does not improve or worsen after regular use of this product as directed

  • Keep this and all drugs out of reach of children

    If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    •wet hair, •squeeze small amount into palm •lather, •rinse well

  • 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

  • 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:51357-001
    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
    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:51357-001-23700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:51357-001-14420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/15/2012
    Labeler - Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil (566220234)
    Establishment
    NameAddressID/FEIBusiness Operations
    Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil566220234manufacture(51357-001)
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