ANTIBACTERIAL FOAMING HAND CLEANSER- triclosan solution

Antibacterial Foaming Hand Cleanser by

Drug Labeling and Warnings

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

Uses

• 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

Warm Vanilla Sugar

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

Sweet Cherry Blossom

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

Fresh Ocean Breeze

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

Cool Cucumber Melon

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

Irresistible Green Apple

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

Alluring Red Pomegranate

Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 40, Red 33, Blue 1

Sparkling White Cranberry

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

Crisp White Citrus

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

Sheer Cotton Whisper

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

Rich Shea & Cocoa Butter

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

Dark Amethyst Rush

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

Merry Berry

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

Peppermint Twist

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

Spring Fling

Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate

Kiss and Tell

Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate

Coconut Lime Verbena

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

Tropical Passion Fruit

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

Questions?

1-800-FDA-1088

Made in China

Distributed by Jets, Sets & Elephants Beauty Corp.

For Shopko Stores Operating Co., LLC

Green Bay, WI 54307, U.S.A.

©2010 Shopko Stores Operating Co., LLC

SATISFACTION GUARANTEED BY REFUND OR EXCHANGE

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Warm

VANILLA SUGAR

antibacterial

foaming

hand soap

PARABEN FREE

contains aloe vera and

vitamins A & E

9.8 fl oz

Warm Vanilla Sugar Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Sweet

CHERRY BLOSSOM

antibacterial

foaming

hand soap

PARABEN FREE

contains aloe vera and

vitamins A & E

9.8 fl oz

Sweet Cherry Blossom Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Fresh

OCEAN BREEZE

antibacterial

foaming

hand soap

PARABEN FREE

contains aloe vera and

vitamins A & E

9.8 fl oz

Fresh Ocean Breeze Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Cool

CUCUMBER MELON

antibacterial

foaming

hand soap

PARABEN FREE

contains aloe vera and

vitamins A & E

9.8 fl oz

Cool Cucumber Melon Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Irresistible

GREEN APPLE

antibacterial

foaming

hand soap

PARABEN FREE

contains aloe vera and

vitamins A & E

9.8 fl oz

Irresistible Green Apple Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Alluring

RED POMEGRANATE

antibacterial

foaming

hand soap

PARABEN FREE

contains aloe vera and

vitamins A & E

9.8 fl oz

Alluring Red Pomegranate Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Sparkling

WHITE CRANBERRY

antibacterial

foaming

hand soap

PARABEN FREE

contains aloe vera and

vitamins A & E

9.8 fl oz

Sparkling White Cranberry Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Crisp

WHITE CITRUS

antibacterial

foaming

hand soap

PARABEN FREE

contains aloe vera and

vitamins A & E

9.8 fl oz

Crisp White Citrus Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Sheer

COTTON WHISPER

antibacterial

foaming

hand soap

PARABEN FREE

contains aloe vera and

vitamins A & E

9.8 fl oz

Sheer Cotton Whisper Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

LIMITED EDITION

Rich

SHEA & COCOA BUTTER

antibacterial

foaming

hand soap

PARABEN FREE

contains aloe vera and

vitamins A & E

9.8 fl oz

Rich Shea & Cocoa Butter Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

LIMITED EDITION

Dark

AMETHYST RUSH

antibacterial

foaming

hand soap

PARABEN FREE

contains aloe vera and

vitamins A & E

9.8 fl oz

Dark Amethyst Rush Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Merry Berry

Antibacterial

Foaming Hand Soap

PARABEN FREE

contains aloe vera and

vitamins A & E

9.8 fl oz

Merry Berry Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Peppermint Twist

Antibacterial

Foaming Hand Soap

PARABEN FREE

contains aloe vera and

vitamins A & E

9.8 fl oz

Peppermint Twist Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Spring Fling

antibacterial

foaming hand soap

paraben free

contains minerals and

vitamins A & E

9.8 fl oz

Spring Fling Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Kiss and Tell

antibacterial

foaming hand soap

paraben free

contains minerals and

vitamins A & E

9.8 fl oz

Kiss and Tell Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

LIMITED EDITION

Coconut Lime Verbena

antibacterial

foaming hand soap

paraben free

contains minerals and

vitamins A & E

9.8 fl oz

Coconut Lime Verbena Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

LIMITED EDITION

Tropical Passion Fruit

antibacterial

foaming hand soap

paraben free

contains minerals and

vitamins A & E

9.8 fl oz

Tropical Passion Fruit Bottle Label

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-170-00	289.82 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/03/2010

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-171
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
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: 50988-171-00	289.82 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/03/2010

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-172
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-172-00	289.82 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/03/2010

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-173
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
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: 50988-173-00	289.82 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/03/2010

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-174
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-174-00	289.82 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/03/2010

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-175
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
FD&C RED NO. 40 (UNII: WZB9127XOA)
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: 50988-175-00	289.82 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/03/2010

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-176
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
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: 50988-176-00	289.82 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/03/2010

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-177
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
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: 50988-177-00	289.82 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/01/2010

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-178
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
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: 50988-178-00	289.82 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/01/2010

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-179
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-179-00	289.82 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/15/2011

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-180
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-180-00	289.82 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/15/2011

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-181
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-181-00	289.92 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/15/2011

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-182
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-182-00	289.92 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/15/2011

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-183
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-183-00	289.82 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/15/2011

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-184
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-184-00	289.82 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/15/2011

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-185
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
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: 50988-185-00	289.82 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/30/2011

ANTIBACTERIAL FOAMING HAND CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-186
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.869 mL  in 289.82 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
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: 50988-186-00	289.82 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/30/2011

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

Establishment
Name	Address	ID/FEI	Business Operations
Gold Orient International Limited		679905914	MANUFACTURE(50988-170, 50988-171, 50988-172, 50988-173, 50988-174, 50988-175, 50988-176, 50988-177, 50988-178, 50988-179, 50988-180, 50988-181, 50988-182, 50988-183, 50988-184, 50988-185, 50988-186)