ANTIBACTERIAL FOAMING HAND SANITIZER- benzalkonium chloride solution

Antibacterial Foaming Hand Sanitizer by

Drug Labeling and Warnings

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

Benzalkonium chloride 0.11%

Purpose

Antibacterial

Uses

• 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

Warm Vanilla Sugar

Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Blue 1, Yellow 5

Sweet Cherry Blossom

Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5 

Fresh Ocean Breeze

Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Blue 1, Yellow 5

Cool Cucumber Melon

Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5

Irresistible Green Apple

Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Blue 1, Yellow 5 

Alluring Red Pomegranate

Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 40, Red 33, Blue 1

Sparkling White Cranberry

Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5

Crisp White Citrus

Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5

Sheer Cotton Whisper

Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Blue 1, Red 33, Yellow 5

Questions?

1-800-FDA-1088

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.

©2010 Shopko Stores Operating Co., LLC

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Warm

VANILLA SUGAR

antibacterial

foaming

hand sanitizer

PARABEN FREE

contains aloe vera and

vitamins A & E

1.7 fl oz

Warm Vanilla Sugar Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Sweet

CHERRY BLOSSOM

antibacterial

foaming

hand sanitizer

PARABEN FREE

contains aloe vera and

vitamins A & E

1.7 fl oz

Sweet Cherry Blossom Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Fresh

OCEAN BREEZE

antibacterial

foaming

hand sanitizer

PARABEN FREE

contains aloe vera and

vitamins A & E

1.7 fl oz

Fresh Ocean Breeze Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Cool

CUCUMBER MELON

antibacterial

foaming

hand sanitizer

PARABEN FREE

contains aloe vera and

vitamins A & E

1.7 fl oz

Cool Cucumber Melon Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Irresistible

GREEN APPLE

antibacterial

foaming

hand sanitizer

PARABEN FREE

contains aloe vera and

vitamins A & E

1.7 fl oz

Irresistible Green Apple Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Alluring

RED POMEGRANATE

antibacterial

foaming

hand sanitizer

PARABEN FREE

contains aloe vera and

vitamins A & E

1.7 fl oz

Alluring Red Pomegranate Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Sparkling

WHITE CRANBERRY

antibacterial

foaming

hand sanitizer

PARABEN FREE

contains aloe vera and

vitamins A & E

1.7 fl oz

Sparkling White Cranberry Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Crisp

WHITE CITRUS

antibacterial

foaming

hand sanitizer

PARABEN FREE

contains aloe vera and

vitamins A & E

1.7 fl oz

Crisp White Citrus Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Sheer

COTTON WHISPER

antibacterial

foaming

hand sanitizer

PARABEN FREE

contains aloe vera and

vitamins A & E

1.7 fl oz

Sheer Cotton Whisper Bottle Label

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL FOAMING HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-190
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.055 mL  in 50.275 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SULISOBENZONE (UNII: 1W6L629B4K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.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: 50988-190-00	50.275 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333E	08/03/2010

ANTIBACTERIAL FOAMING HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-191
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.055 mL  in 50.275 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SULISOBENZONE (UNII: 1W6L629B4K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.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: 50988-191-00	50.275 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333E	08/03/2010

ANTIBACTERIAL FOAMING HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-192
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.055 mL  in 50.275 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SULISOBENZONE (UNII: 1W6L629B4K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.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: 50988-192-00	50.275 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333E	08/03/2010

ANTIBACTERIAL FOAMING HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-193
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.055 mL  in 50.275 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SULISOBENZONE (UNII: 1W6L629B4K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.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: 50988-193-00	50.275 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333E	08/03/2010

ANTIBACTERIAL FOAMING HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-194
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.055 mL  in 50.275 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SULISOBENZONE (UNII: 1W6L629B4K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.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: 50988-194-00	50.275 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333E	08/03/2010

ANTIBACTERIAL FOAMING HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-195
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.055 mL  in 50.275 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SULISOBENZONE (UNII: 1W6L629B4K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.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: 50988-195-00	50.275 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333E	08/03/2010

ANTIBACTERIAL FOAMING HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-196
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.055 mL  in 50.275 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SULISOBENZONE (UNII: 1W6L629B4K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.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: 50988-196-00	50.275 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333E	08/03/2010

ANTIBACTERIAL FOAMING HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-197
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.055 mL  in 50.275 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SULISOBENZONE (UNII: 1W6L629B4K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.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: 50988-197-00	50.275 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333E	12/01/2010

ANTIBACTERIAL FOAMING HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-198
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.055 mL  in 50.275 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SULISOBENZONE (UNII: 1W6L629B4K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.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: 50988-198-00	50.275 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333E	12/01/2010

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

Establishment
Name	Address	ID/FEI	Business Operations
Gold Orient International Limited		679905914	MANUFACTURE