Label: SHOPKO ANTIBACTERIAL HAND SANITIZER- ethyl alcohol gel

  • 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 March 21, 2012

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 62% w/w

  • PURPOSE

    Anti-bacterial

  • USE

    • To decrease bacteria on the skin and clean hands.
    • Recommended for repeated use.
  • WARNINGS

    For external use only. Flammable, keep away from fire or flame.

    Keep out of reach of children.

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

    Do not get into eyes.

    If contact occurs, rinse thoroughly with water.

    Discontinue use

    if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor.

  • DIRECTIONS

    • Apply to hands until thoroughly wet.
    • Rub vigorously until dry.
    • Supervise children in the use of this product.
  • Inactive Ingredients

    Rebel ocean breeze

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Red 40, Yellow 5

    Drama queen vanilla kiss

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines

    Candy apple

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Red 40, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines

    Sweet melon

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5

  • QUESTIONS?

    1-800-FDA-1088

    Made in China

    Distributed by Jets, Sets & Elephants Beauty Corp.

    For ShopKo Stores Operating Co., LLC

    Green Bay, WI 54307, U.S.A

    ©2010 ShopKo Stores Operating Co., LLC

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

    bath body etc®

     Rebel ocean breeze

    anti-bacterial

    hand gel

    1 fl. oz.

    Rebel ocean breeze Bottle Label

    Rebel ocean breeze Bottle Label

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

    bath body etc®

     Drama queen vanilla kiss

    anti-bacterial

    hand gel

    1 fl. oz.

    Drama Queen vanilla kiss Bottle Label

    Drama queen vanilla kiss Bottle Label

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

    bath body etc®

     Candy apple

    anti-bacterial

    hand gel

    1 fl. oz.

    Candy apple Bottle Label

    Candy apple Bottle Label

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

    bath body etc®

     Sweet melon

    anti-bacterial

    hand gel

    1 fl. oz.

    Sweet melon Bottle Label

    Sweet melon Bottle Label

  • INGREDIENTS AND APPEARANCE
    SHOPKO ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-280
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LACTOSE (UNII: J2B2A4N98G)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-280-0030 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/20/2012
    SHOPKO ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-281
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LACTOSE (UNII: J2B2A4N98G)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-281-0030 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/20/2012
    SHOPKO ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-282
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LACTOSE (UNII: J2B2A4N98G)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-282-0030 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/20/2012
    SHOPKO ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-283
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LACTOSE (UNII: J2B2A4N98G)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-283-0030 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/20/2012
    Labeler - Jets, Sets, & Elephants Beauty Corp. (243254039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gold Orient International Limited679905914MANUFACTURE(50988-280, 50988-281, 50988-282, 50988-283)
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