SHOPKO ANTIBACTERIAL HAND SANITIZER- ethyl alcohol gel

Shopko Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Shopko Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Jets, Sets, & Elephants Beauty Corp., Gold Orient International Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

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

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

Warm Vanilla Sugar

INGREDIENTS AND APPEARANCE

SHOPKO ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-288
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-288-00	30 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/21/2012

SHOPKO ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-289
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-289-00	30 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/21/2012

SHOPKO ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-400-00	30 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/21/2012

SHOPKO ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-401-00	30 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/21/2012

SHOPKO ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-402
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-402-00	30 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/21/2012

Labeler - Jets, Sets, & Elephants Beauty Corp. (243254039)

Establishment
Name	Address	ID/FEI	Business Operations
Gold Orient International Limited		679905914	MANUFACTURE(50988-288, 50988-289, 50988-400, 50988-401, 50988-402)