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 Ingredients
Ethyl Alcohol 62%

Purpose
Antiseptic

Use: To help reduce bacteria on the skin

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. 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 unitl dry. Children under 6 years old should be supervised when using this product.                                                                                                                                                                           
Other Information:
Store below 118 F

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.

image of bottle label
ANTI-BACTERIAL HAND GEL  
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69358-0004
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LACTOSE (UNII: J2B2A4N98G)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
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)  
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:69358-0004-129 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/12/2014
Labeler - UniGroup Wholesale Inc. (079591424)

Revised: 11/2014
Document Id: c1de95a1-c4b6-46ee-98c5-62d519198075
Set id: 82e93f71-84b0-4933-84e8-1fa532b9ddf6
Version: 1
Effective Time: 20141112
 
UniGroup Wholesale Inc.