Label: LUCKY 2IN1 CLASSIC- 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 November 29, 2019

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  • 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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