Label: ANTIBACTERIAL FOAMING HAND- benzalkonium chloride solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated January 23, 2012

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    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

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!