LUCKY 2IN1 CLASSIC (PYRITHIONE ZINC) SHAMPOO [DELTA BRANDS INC]

LUCKY 2IN1 CLASSIC (PYRITHIONE ZINC) SHAMPOO [DELTA BRANDS INC]
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NDC 20276-046-12, 20276-046-14
Set ID 6f0a19ce-b717-4ed7-ae41-3fc530b3f314
Category HUMAN OTC DRUG LABEL
Packager Delta Brands Inc
Generic Name
Product Class
Product Number
Application Number PART358H
  • Active Ingredient

    Pyrithione zinc 0.3%

  • 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 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.

  • Directions

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

  • Inactive ingredients

    acrylates copolymer, benzyl alcohol, cocamidopropyl betaine, cocamide DEA, cocamide MEA, coco-glucoside, dimethicone, FD&C blue no. 1, fragrance, glycol distearate, laureth-10, methylchloroisothiazolinone, methylisothiazolinone, polyquaternium-10, sodium chloride, sodium laureth sulfate, styrene/acrylates coploymer,tetrasodium EDTA, triethanolamine, water, zinc acetate

  • Package Label

    image of package label

  • INGREDIENTS AND APPEARANCE
    LUCKY  2IN1 CLASSIC
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-046
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    LAURETH-10 (UNII: BD7AST04GA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-046-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2012
    2NDC:20276-046-14420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/30/2012
    Labeler - Delta Brands Inc (102672008)
    Establishment
    NameAddressID/FEIBusiness Operations
    Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil566220234manufacture(20276-046)

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