BUBBLE GUM- antibacterial hand sanitizer gel gel

Bubble Gum by

Drug Labeling and Warnings

Bubble Gum by is a Otc medication manufactured, distributed, or labeled by Brands Internation Corp, Brands International Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BUBBLE GUM 
antibacterial hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50157-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	620 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50157-116-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/10/2015

Labeler - Brands Internation Corp (243748238)

Establishment
Name	Address	ID/FEI	Business Operations
Brands International Corp		243748238	manufacture(50157-116)