HAND SANITIZER- alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Vi-Jon, LLC, Vi Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

claims

germ-X

Professional

ORIGINAL

HAND SANITIZER

ACTIVE INGREDIENTS

Ethyl alcohol 63%

purpose

Antiseptic

use

• to decrease bacteria on the skin that could cause disease
• recommended for repeated use

warnings

For external use only: hands

Flammable, keep away from fire or 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

• irritation or redness develops
• condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact 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 105°F
• may discolor some fabrics
• harmful to wood finishes and plastics

inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, benzophenone-4, fragrance, glycerin, tocopherol, water

claims

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

adverse reactions

DISTRIBUTED BY: VI-JON, INC.

8515 Page Ave

ST. LOUIS, MO 63114

vijonprofessional.com

437.000/437AA

Principal display panel

germ-X

Professional

ORIGINAL

HAND SANITIZER

kILLS 99.99% of Germs

With Vitamin E

128 FL OZ (1 GAL) 3.79

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-437
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SULISOBENZONE (UNII: 1W6L629B4K)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-437-27	1150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016
2	NDC: 11344-437-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016
3	NDC: 11344-437-20	44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016
4	NDC: 11344-437-16	59 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/13/2016
5	NDC: 11344-437-18	73 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016
6	NDC: 11344-437-21	88 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016
7	NDC: 11344-437-26	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016
8	NDC: 11344-437-63	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016
9	NDC: 11344-437-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016
10	NDC: 11344-437-38	295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016
11	NDC: 11344-437-32	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016
12	NDC: 11344-437-49	443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016
13	NDC: 11344-437-04	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016
14	NDC: 11344-437-42	828 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/13/2016
15	NDC: 11344-437-09	887 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016
16	NDC: 11344-437-57	1656 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016
17	NDC: 11344-437-68	1972 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016
18	NDC: 11344-437-08	44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/13/2016

Labeler - Vi-Jon (150931459)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		150931459	manufacture(11344-437)