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 (Frosted Vanilla)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Blue 1, Cellulose, Fragrance (Parfume), Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Water (Aqua), Yellow 5

Inactive ingredients (Merry Berry)

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

Inactive ingredients (Winter Gumdrop)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Blue 1, Cellulose, Fragrance (Parfume), Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Water (Aqua), Yellow 5

QUESTIONS?

1-800-FDA-1088

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

Frosted Vanilla

anti-bacterial hand gel

1 fl. oz.

SATISFACTION GUARANTEED BY REFUND OR EXCHANGE

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

Bottle Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

Merry Berry

anti-bacterial hand gel

1 fl. oz.

SATISFACTION GUARANTEED BY REFUND OR EXCHANGE

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

Bottle Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

Winter Gumdrop

anti-bacterial hand gel

1 fl. oz.

SATISFACTION GUARANTEED BY REFUND OR EXCHANGE

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

Bottle Label

INGREDIENTS AND APPEARANCE

SHOPKO ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-405
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: 50988-405-00	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	07/02/2012

SHOPKO ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-406
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 RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-406-00	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	07/02/2012

SHOPKO ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-407
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: 50988-407-00	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	07/02/2012

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

Establishment
Name	Address	ID/FEI	Business Operations
Gold Orient International Limited		679905914	MANUFACTURE(50988-405, 50988-406, 50988-407)