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, Avmor, Chemisphere Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Germ-X Professional

ADVANCED FOAMING HAND SANITIZER

Active ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

• 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 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 suervision
• not recommended for infants

Other information

• do not store above 105° F
• may discolor some fabrics
• harmful to wood finishes and plastics

Inactive ingredients

water, PEG-8 Dimethicone, meadowfoamamidopropyl betaine, glyceryl caprylate/caprate, glycerin, tocopheryl acetate, isopropyl Myristate

SPL UNCLASSIFIED SECTION

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

DISTRIBUTED BY: VI-JON, INC.

8515 Page Ave

ST. LOUIS, MO 63114

vijonprofessional.com

456.001/456AC

principal display panel

Germ-X Professional

ADVANCED FOAMING HAND SANITIZER

Kills 99.99% of Germs Instantly*

Fragrance Free

Dye Free

128 FL OZ (1 GAL) 379 L

principal display panel

Germ-X Professional

E3 ADVANCED FOAMING HAND SANITIZER

Kills 99.99% of Germs*

Fragrance & Dye Free

USDA CERTIFIED BIOBASED PRODUCT NSF

Nonfood Compounds Program Listed (Code E3)

7.5 FL OZ (221 mL)

principal display panel

Germ-X Advanced Foaming Hand Sanitizer

Distributed by: Vi-Jon, Inc., 8515 Page Ave. St. Louis, MO 63114

www.vijonprofessional.com

Pat. 9,161,982

Made in Canada

500 mL/16.9 FL OZ

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-456
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	.70 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
MEADOWFOAMAMIDOPROPYL BETAINE (UNII: HNV0L650LG)
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-456-45	1150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/10/2016
2	NDC: 11344-456-07	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2016
3	NDC: 11344-456-16	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2016
4	NDC: 11344-456-96	221 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2016
5	NDC: 11344-456-49	443 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package	06/10/2016
6	NDC: 11344-456-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2016
7	NDC: 11344-456-76	500 mL in 1 BAG; Type 0: Not a Combination Product	10/26/2018
8	NDC: 11344-456-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2016
9	NDC: 11344-456-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2016
10	NDC: 11344-456-08	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2016
11	NDC: 11344-456-20	44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/10/2016

Labeler - Vi-Jon (150931459)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		150931459	manufacture(11344-456)

Establishment
Name	Address	ID/FEI	Business Operations
Avmor		202107827	manufacture(11344-456)