Label: BUBBLE GUM- antibacterial hand sanitizer gel gel

  • 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 10, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient - Ethyl Alcohol 62%

  • PURPOSE

    Purpose - Antiseptic

  • INDICATIONS & USAGE

    Use

    • to decrease bacteria on the skin and clean hands
    • recommeded for repeated use
  • WARNINGS

    Warnings

    for external use only

    Flammable, keep away from fire or flame

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of children. If accidently swallowed, get medical helpor contact a Poison Control Center right away

  • USER SAFETY WARNINGS

    Do not get into eyes, If contact occurs, rinse thoroughly with water

  • ASK DOCTOR/PHARMACIST

    Discontinue Use if irritation or redness develops, If irritation persists for more than 72 hours, consult a doctor

  • DOSAGE & ADMINISTRATION

    Directions

    • apply to hands until thoroughly wet
    • rub vigorously until dry
    • supervise children in the use of this product
  • USER SAFETY WARNINGS

    Other information

    • may discolor certain fabrics or surfaces
    • do not store above 110 F (43 C)
  • INACTIVE INGREDIENT

    Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Prpanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Acetate, Sunflower (Heilanthus Annuus) Seed Extract, Grapefruit (Citrus Grandis) Seed Extract, yellow 6 (Cl 15985) Red 40 (Cl 16035)

  • PRINCIPAL DISPLAY PANEL

    Bubble Gum Antibacterial Hand Sanitizer Gel

  • INGREDIENTS AND APPEARANCE
    BUBBLE GUM 
    antibacterial hand sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-116-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product01/10/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/10/2015
    Labeler - Brands Internation Corp (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International Corp243748238manufacture(50157-116)
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