Label: SHOPKO ANTIBACTERIAL FOAMING HAND CLEANSER- triclosan solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 11, 2012

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  • Active ingredient

    Triclosan 0.3%

  • Purpose

    Antibacterial

  • Use

    • handwashing to decrease bacteria on skin
  • Warnings

    For external use only.

    When using this product

    avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor

    if irritation and redness develop.

    Keep out of reach of children.

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

  • Directions

    • wet hands, work into rich lather
    • rinse well
  • Inactive ingredients (cinnamon pumpkin spice)

    Aloe Barbadensis Leaf Juice, Aqua, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Yellow 5

  • Inactive ingredients (vanilla scream)

    Aloe Barbadensis Leaf Juice, Aqua, Benzophenone-4, Blue-1, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Yellow 5

  • QUESTIONS?

    1-800-FDA-1088

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    bath·body·etc®

    cinnamon pumpkin spice

    ANTI-BACTERIAL FOAMING

    HAND SOAP

    10.1 fl.oz

    Made in China

    Distributed by Jets, Sets & Elephants Beauty Corp.

    For ShopKo Stores Operating Co., LLC

    Green Bay, WI 54307, U.S.A

    ©2012 ShopKo Stores Operating Co., LLC

    SATISFACTION GUARANTEED BY REFUND OR EXCHANGE

    Bottle Label

    Bottle Label

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    bath·body·etc®

    vanilla scream

    ANTI-BACTERIAL FOAMING

    HAND SOAP

    10.1 fl.oz

    Made in China

    Distributed by Jets, Sets & Elephants Beauty Corp.

    For ShopKo Stores Operating Co., LLC

    Green Bay, WI 54307, U.S.A

    ©2012 ShopKo Stores Operating Co., LLC

    SATISFACTION GUARANTEED BY REFUND OR EXCHANGE

    Bottle Label

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    SHOPKO ANTIBACTERIAL FOAMING HAND CLEANSER 
    triclosan solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-294
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    ACETYL TRIETHYLHEXYL CITRATE (UNII: 150CTM9A3J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-294-00300 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/11/2012
    SHOPKO ANTIBACTERIAL FOAMING HAND CLEANSER 
    triclosan solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-295
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    ACETYL TRIETHYLHEXYL CITRATE (UNII: 150CTM9A3J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-295-00300 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/11/2012
    Labeler - Jets, Sets, & Elephants Beauty Corp. (243254039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gold Orient International Limited679905914MANUFACTURE(50988-294, 50988-295)
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