SHOPKO ANTIBACTERIAL FOAMING HAND CLEANSER- triclosan solution

Shopko Antibacterial Foaming Hand Cleanser by

Drug Labeling and Warnings

Shopko Antibacterial Foaming Hand Cleanser 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 (Merry Berry)

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

Inactive ingredients (Peppermint Twist)

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

QUESTIONS?

1-800-FDA-1088

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

Merry Berry

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®

Peppermint Twist

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 CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 mL  in 100 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: 50988-303-00	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	07/02/2012

SHOPKO ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-304
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 mL  in 100 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)
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: 50988-304-00	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	07/02/2012

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

Establishment
Name	Address	ID/FEI	Business Operations
Gold Orient International Limited		679905914	MANUFACTURE(50988-303, 50988-304)