ANTI-BACTERIAL HAND GEL- ethyl alcohol gel 
GASSER, MOHAMED

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

Warnings:

For external use only.

Flammable. Keep away from fire or flame.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children.

Directions:
Pump as needed into your palms to cover hands. Rub hands together briskly until dry. Children under 6 years old should be supervised when using this product.

Inactive ingredients: Water, Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxypropyl Methyl Cellulose, FD&C Blue NO.1, FD&C Yellow NO.5.

Other information: Store below 118 F.

Uses: To help reduce bacteria on the skin.

image of bottle label

ANTI-BACTERIAL HAND GEL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69909-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
SUCROSE (UNII: C151H8M554)  
STARCH, CORN (UNII: O8232NY3SJ)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
LACTOSE (UNII: J2B2A4N98G)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69909-001-0129 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/11/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/11/2015
Labeler - GASSER, MOHAMED (079814607)

Revised: 6/2015
Document Id: 183935e8-6179-545b-e054-00144ff8d46c
Set id: 183935e8-6178-545b-e054-00144ff8d46c
Version: 1
Effective Time: 20150611
 
GASSER, MOHAMED