HAND SANITIZER- alcohol lotion 
Vi-Jon, LLC

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 616

Active ingredient

Ethyl alcohol 62%

Purpose

Antiseptic

Use

for handwashing to decrease bacteria on the skin.

Warnings

for external use only-hands

Flammable

Keep away from heat and flame.

When using this product

  • keep out of eyes.  In case of contact with eyes, flush thoroughly with water
  • avoid contact with broken skin
  • do not inhale or ingest

Stop use and ask a doctor if

skin irritation develops

Stop use and ask a doctor if

stop use and ask a doctor if swallowed get medical help or contact a Poison Control Center right away.

Directions

  • wet hands thoroughly with product and allow to dry without wiping
  • for children under 6, use only under adult supervision
  • not recommended for infants

Other information

  • do not store above 105⁰ F
  • may discolor some fabrics
  • harmful to wood finishes and plastics

Inactive ingredients

benzophenone-4, blue 1, carbomer, fragrance, glycerin, isopropyl alcohol, isopropyl myristate, red 33, tocopheryl acetate, water

Adverse Reaction

Distributed by 

Vi-Jon, LLC

8515 Page Ave

St. Louis, MO 63114

principal display panel

NDC 11344-616-18

Blastin' Blueberry

germ blaster

HAND SANITIZER

germ-X

KILLS 99.99% OF GERMS

2.5 FL OZ (73 mL)

image description

HAND SANITIZER 
alcohol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-616
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11344-616-1873 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/19/200505/03/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/19/200505/03/2021
Labeler - Vi-Jon, LLC (150931459)
Registrant - Vi-Jon, LLC (150931459)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC150931459manufacture(11344-616)

Revised: 5/2021
 
Vi-Jon, LLC