HAND SANITIZER- ethyl alcohol gel 
Vi-Jon

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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Germ-x 989

Active ingredient

Ethyl alcohol 62%

Purpose

Antiseptic

Uses

Warnings

For external use only:hands

Flammable

Keep away from heat and flame

when using this product

Stop use and ask a doctor

Keep  out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Other information

Inactive ingredients

water, glycerin, tocopheryl acetate, retinyl palmitate, carbomer, fragrance, benzophenone-4, mannitol, cellulose, hydroxypropyl methylcellulose, ultamarines, blue 1, red 40, yellow 5

claims

Effective at eliminating 99.99% of many common harmful germs and bacteria in as little as 15 seconds.

adverse reactions section

Distributed by: Vi-Jon 8515 Page Ave.  

St. Louis, MO 63114

princpal display panel

germ-x

hand sanitizer

coconut water

KILLS 99.99% OF GERMS

1.11 FL OZ (32 mL)

image description

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-989
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL545 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
SULISOBENZONE (UNII: 1W6L629B4K)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11344-989-0632 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package10/08/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/08/2014
Labeler - Vi-Jon (150931459)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon088520668manufacture(11344-989)

Revised: 1/2020
Document Id: f3ebf31c-f838-4442-8604-98f835ad5c6d
Set id: ba4fee8e-b85e-4390-aa65-bcb819fc4099
Version: 2
Effective Time: 20200117
 
Vi-Jon