BUBBLE GUM- antibacterial hand sanitizer gel gel 
Brands Internation 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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Active Ingredient - Ethyl Alcohol 62%

Purpose - Antiseptic

Use

Warnings

for external use only

Flammable, keep away from fire or flame

Keep out of children. If accidently swallowed, get medical helpor 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 develops, If irritation persists for more than 72 hours, consult a doctor

Directions

Other information

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)

Bubble Gum Antibacterial Hand Sanitizer Gel

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)

Revised: 1/2015
Document Id: 3f8bfbc5-c5c0-1523-e054-00144ff8d46c
Set id: 3f8bfbc5-c5bf-1523-e054-00144ff8d46c
Version: 1
Effective Time: 20150110
 
Brands Internation Corp