Drug Labeling and Warnings

Drug Details

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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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Active ingredient

Ethyl alcohol 63%

Purpose

Antiseptic

Uses

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.  Incase 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 irritation and redness develop
  • condition persists for more than 72 hours

Keep  out of reach of children

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 105⁰F
  • may discolor some fabrics
  • harmful to wood finishes and plastics

Inactive ingredients

water, glycerin, tocopheryl acetate, retinyl palmitate, acrylates/C10-30 alkyl acrylate crosspolymer, benzophenone-4, mannitol, cellulose, hydroxypropyl methylcellulose, fragrance, ext. violet 2, blue 1, red 40, ultramarines

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

www.germx.com

604.000/604AA

principal display panel

germ-X

HAND SANITIZER

Coastal Breeze

KILLS 99.99% OF GERMS

1.25 FL OZ (0.37 mL)

image description

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11344-604
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL567 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)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11344-604-720.37 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/14/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/14/2014
Labeler - Vi-Jon (150931459)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon088520668manufacture(11344-604)

Revised: 2/2019
 
Vi-Jon


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