ANTI-BACTERIAL HAND GEL- ethyl alcohol gel 
UniGroup Wholesale Inc.

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 for a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a doctor right away.

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 Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxpropyl Methyl Cellulose, FD&C Blue No.1, FD&C Yellow No.5, FD&C Red No.33, FD&C Red No.4.

Other Information: Store below 118 F.

UseTo 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:69358-0008
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
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
LACTOSE (UNII: J2B2A4N98G)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SUCROSE (UNII: C151H8M554)  
STARCH, CORN (UNII: O8232NY3SJ)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69358-0008-129 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/25/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/25/2015
Labeler - UniGroup Wholesale Inc. (079591424)

Revised: 9/2015
Document Id: 208ac248-e133-6aa5-e054-00144ff8d46c
Set id: 208abf83-febf-2399-e054-00144ff88e88
Version: 1
Effective Time: 20150925
 
UniGroup Wholesale Inc.