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 June 28, 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 (Ocean Breeze)

    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, and Ultramarines

  • Inactive ingredients (Cherry Blossom)

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

  • Inactive ingredients (Red Pomegranate)

    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, Yellow 5

  • Inactive ingredients (Dark Raspberry)

    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, Yellow 5

  • Inactive ingredients (Warm Vanilla Sugar)

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

  • QUESTIONS?

    1-800-FDA-1088

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    bath·body·etc®

    Ocean Breeze

    anti-bacterial hand gel

    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

    Principal Display Panel - Ocean Breeze

    Ocean Breeze

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    bath·body·etc®

    Cherry Blossom

    anti-bacterial hand gel

    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

    Principal Display Panel - Cherry Blossom

    Cherry Blossom

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    bath·body·etc®

    Red Pomegranate

    anti-bacterial hand gel

    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

    Principal Display Panel - Red Pomegranate

    Red Pomegranate

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    bath·body·etc®

    Dark Raspberry

    anti-bacterial hand gel

    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

    Principal Display Panel - Dark Raspberry

    Dark Raspberry

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    bath·body·etc®

    Warm Vanilla Sugar

    anti-bacterial hand gel

    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

    Principal Display Panel - Warm Vanilla Sugar

    Warm Vanilla Sugar

  • INGREDIENTS AND APPEARANCE
    SHOPKO ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-288
    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)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LACTOSE (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    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:50988-288-0030 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/21/2012
    SHOPKO ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-289
    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)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LACTOSE (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    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 YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-289-0030 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/21/2012
    SHOPKO ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-400
    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)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LACTOSE (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    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 YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-400-0030 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/21/2012
    SHOPKO ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-401
    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)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LACTOSE (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    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 YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-401-0030 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/21/2012
    SHOPKO ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-402
    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)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LACTOSE (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    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 YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50988-402-0030 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/21/2012
    Labeler - Jets, Sets, & Elephants Beauty Corp. (243254039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gold Orient International Limited679905914MANUFACTURE(50988-288, 50988-289, 50988-400, 50988-401, 50988-402)
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