HAND SANITIZER- 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.

----------

Claims

germ-X

HandiSani

Hand Sanitizer

Active Ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Use

Uses

for handwashing to decrease bacteria on the skin
recommended for repeated use

Warnings

For external use only-hands

Flammable

Flammable. Keep away from heat and flame.

When using this product

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

Stop use

Stop use and ask a doctor if skin irritation develops

Keep out of reach of children

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

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

Inactive ingredients

Inactive ingredients benzophene-4, blue1, carbomer, cellulose, fragrance, glycerin, hydroxypropyl methylcellose, mannitol, retinyl palmitate, tocopheryl acetate, ultramarines, water, yellow 5

Adverse reactions

Distributed By: Vi-Jon

8515 Page Ave

St. Louis, MO 63114

Principal Display Panel

cucumber

melon

HandiSani

HAND SANITIZER

germ-X

8 FL OZ (236 mL)

image description

HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11344-410
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (ALCOHOL)	ALCOHOL	585 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SULISOBENZONE
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
POWDERED CELLULOSE
GLYCERIN
HYPROMELLOSES
MANNITOL
VITAMIN A PALMITATE
.ALPHA.-TOCOPHEROL ACETATE
ULTRAMARINE BLUE
WATER
FD&C YELLOW NO. 5

Packaging
#	Item Code	Package Description
1	NDC:11344-410-34	236 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/30/2012

Labeler - Vi-Jon (150931459)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture(11344-410)

Revised: 10/2012

Document Id: 702e308f-ebbf-4621-b8a1-4b2252be3596

Set id: 48ec30d1-b18b-41be-97cf-41d7e9bf047f

Version: 1

Effective Time: 20121012

Vi-Jon