SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER- triclosan gel

Shopko Antibacterial Foaming Hand Sanitizer by

Drug Labeling and Warnings

Shopko Antibacterial Foaming 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

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 (Cherry Blossom)

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

Inactive ingredients (Ocean Breeze)

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

Inactive ingredients (Warm Vanilla Sugar)

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

Inactive ingredients (Dark Raspberry)

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

Inactive ingredients (Red Pomegranate)

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

Inactive ingredients (Autumn Orange)

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

Inactive ingredients (Enchanted Woods)

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

QUESTIONS?

1-800-FDA-1088

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

CHERRY BLOSSOM

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

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

OCEAN BREEZE

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

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

WARM VANILLA SUGAR

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

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

DARK RASPBERRY

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

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

RED POMEGRANATE

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

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

limited edition
autumn orange

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

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

limited edition
enchanted woods

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

INGREDIENTS AND APPEARANCE

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER 
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-296
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-296-00	300 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	08/07/2012

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER 
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-297
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-297-00	300 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	08/07/2012

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER 
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-298
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-298-00	300 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	08/07/2012

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER 
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-299
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-299-00	300 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	08/07/2012

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER 
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-300-00	300 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	08/07/2012

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER 
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-301-00	300 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	08/07/2012

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER 
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-302-00	300 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	08/07/2012

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

Establishment
Name	Address	ID/FEI	Business Operations
Gold Orient International Limited		679905914	MANUFACTURE(50988-296, 50988-297, 50988-298, 50988-299, 50988-300, 50988-301, 50988-302)