ANTIBACTERIAL FOAMING HAND- benzalkonium chloride solution

Antibacterial Foaming Hand by

Drug Labeling and Warnings

Antibacterial Foaming Hand 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

Antiseptic

Use

• hand washing 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.

Discontinue use 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

Banana

Benzophenone-4, Citric Acid, Cocamidopropyl Betaine, Parfum, Methylisothiazolinone, Phenoxyethanol, Polysorbate 20, Retinyl Palmitate, Sodium Lauroyl Glutamate, Sodium Lauroyl Sarcosinate, Tocopheryl Acetate, Aqua, Yellow 5

Blueberry

Benzophenone-4, Citric Acid, Cocamidopropyl Betaine, Parfum, Methylisothiazolinone, Phenoxyethanol, Polysorbate 20, Retinyl Palmitate, Sodium Lauroyl Glutamate, Sodium Lauroyl Sarcosinate, Tocopheryl Acetate, Aqua, Blue 1, Red 33

Cherry

Benzophenone-4, Citric Acid, Cocamidopropyl Betaine, Parfum, Methylisothiazolinone, Phenoxyethanol, Polysorbate 20, Retinyl Palmitate, Sodium Lauroyl Glutamate, Sodium Lauroyl Sarcosinate, Tocopheryl Acetate, Aqua, Red 33, Red 40

Grape

Benzophenone-4, Citric Acid, Cocamidopropyl Betaine, Parfum, Methylisothiazolinone, Phenoxyethanol, Polysorbate 20, Retinyl Palmitate, Sodium Lauroyl Glutamate, Sodium Lauroyl Sarcosinate, Tocopheryl Acetate, Aqua, Blue 1, Red 33

Questions?

1-800-FDA-1088

©2012 The Wiggles Pty Ltd.

IMPORTED BY:

JETS, SETS, & ELEPHANTS BEAUTY CORP.

LAVAL (QC) CANADA H7T 2R2

DEVELOPED IN NORTH AMERICA

MADE IN CHINA

Principal Display Panel - Bottle Label

The Wiggles®

Antibacterial

Foaming

Hand Soap

BRIGHT COLORED FOAM

PARABEN FREE

BANANA

10 fl. oz.

As The Wiggles say,
Wash Your Hands! This
foaming hand soap not only
smells delicious but will make
your child's hand washing
routine fun with its colored
foam! The natural formula is
enriched with vitamins A & E that
will moisturize and protect your
child's sensitive skin.

Free of: Synthetic Fragrances,
Phthalates, Parabens, Sulfates

Banana Bottle Label

Principal Display Panel - Bottle Label

The Wiggles®

Antibacterial

Foaming

Hand Soap

BRIGHT COLORED FOAM

PARABEN FREE

BLUEBERRY

10 fl. oz.

As The Wiggles say,
Wash Your Hands! This
foaming hand soap not only
smells delicious but will make
your child's hand washing
routine fun with its colored
foam! The natural formula is
enriched with vitamins A & E that
will moisturize and protect your
child's sensitive skin.

Free of: Synthetic Fragrances,
Phthalates, Parabens, Sulfates

Blueberry Bottle Label

Principal Display Panel - Bottle Label

The Wiggles®

Antibacterial

Foaming

Hand Soap

BRIGHT COLORED FOAM

PARABEN FREE

CHERRY

10 fl. oz.

As The Wiggles say,
Wash Your Hands! This
foaming hand soap not only
smells delicious but will make
your child's hand washing
routine fun with its colored
foam! The natural formula is
enriched with vitamins A & E that
will moisturize and protect your
child's sensitive skin.

Free of: Synthetic Fragrances,
Phthalates, Parabens, Sulfates

Cherry Bottle Label

Principal Display Panel - Bottle Label

The Wiggles®

Antibacterial

Foaming

Hand Soap

BRIGHT COLORED FOAM

PARABEN FREE

GRAPE

10 fl. oz.

As The Wiggles say,
Wash Your Hands! This
foaming hand soap not only
smells delicious but will make
your child's hand washing
routine fun with its colored
foam! The natural formula is
enriched with vitamins A & E that
will moisturize and protect your
child's sensitive skin.

Free of: Synthetic Fragrances,
Phthalates, Parabens, Sulfates

Grape Bottle Label

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL FOAMING HAND 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-290
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.325 mL  in 295.74 mL

Inactive Ingredients
Ingredient Name	Strength
SULISOBENZONE (UNII: 1W6L629B4K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-290-00	295.74 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/25/2012

ANTIBACTERIAL FOAMING HAND 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-291
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.325 mL  in 295.74 mL

Inactive Ingredients
Ingredient Name	Strength
SULISOBENZONE (UNII: 1W6L629B4K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-291-00	295.74 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/25/2012

ANTIBACTERIAL FOAMING HAND 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-292
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.325 mL  in 295.74 mL

Inactive Ingredients
Ingredient Name	Strength
SULISOBENZONE (UNII: 1W6L629B4K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
WATER (UNII: 059QF0KO0R)
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: 50988-292-00	295.74 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/25/2012

ANTIBACTERIAL FOAMING HAND 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-293
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.325 mL  in 295.74 mL

Inactive Ingredients
Ingredient Name	Strength
SULISOBENZONE (UNII: 1W6L629B4K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-293-00	295.74 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/25/2012

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

Establishment
Name	Address	ID/FEI	Business Operations
Gold Orient International Limited		679905914	MANUFACTURE(50988-290, 50988-291, 50988-292, 50988-293)