ANTIBACTERIAL FOAMING HAND- benzalkonium chloride solution 
Jets, Sets, & Elephants Beauty Corp.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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The Wiggles® Antibacterial Foaming Hand Soap - Banana, Blueberry, Cherry, Grape

Active ingredient

Benzalkonium Chloride 0.11%

Purpose

Antiseptic

Use

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

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

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

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

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

Grape Bottle Label

ANTIBACTERIAL FOAMING HAND 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-290
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.325 mL  in 295.74 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50988-290-00295.74 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/25/2012
ANTIBACTERIAL FOAMING HAND 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-291
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.325 mL  in 295.74 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50988-291-00295.74 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/25/2012
ANTIBACTERIAL FOAMING HAND 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-292
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.325 mL  in 295.74 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50988-292-00295.74 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/25/2012
ANTIBACTERIAL FOAMING HAND 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-293
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.325 mL  in 295.74 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50988-293-00295.74 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/25/2012
Labeler - Jets, Sets, & Elephants Beauty Corp. (243254039)
Establishment
NameAddressID/FEIBusiness Operations
Gold Orient International Limited679905914MANUFACTURE(50988-290, 50988-291, 50988-292, 50988-293)

Revised: 1/2012
Document Id: 26c4a966-78fa-4069-9f4a-dedff5ab972e
Set id: 26c4a966-78fa-4069-9f4a-dedff5ab972e
Version: 1
Effective Time: 20120123
 
Jets, Sets, & Elephants Beauty Corp.