ANTIBACTERIAL HAND WASH- benzalkonium chloride 0.13% liquid

Antibacterial Hand Wash by

Drug Labeling and Warnings

Antibacterial Hand Wash by is a Otc medication manufactured, distributed, or labeled by Vi-Jon, Inc, Vi-Jon. nc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

claims

germ-X

Professional

ALCOHOL FREE

FOAMING HAND SANITIZER

ACTIVE INGREDIENTS

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Use

to decrease bacteria on the skin

Warnings

For external use only: hands only

When using this product

• avoid contact with the eyes.  If contact occurs, rinse eyes with water
• avoid contact with broken skin

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 a Poison Control Center right away.

Directions

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

other information

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

Inactive ingredients

cetrimonium chloride, diglycerol, disodium cocamphodiacetate, fragrance, glycerin, hydrochloric acid, methoxy PEG/PPG-7/3 aminopropyl

dimethicone, methylchloroisothiazolinone, methylisothiazolinone, tetrasodium EDTA, Water

claims

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

Adverse Reactions

Manufactured By: Vi-Jon, Inc.

8515 Page Ave

St. Louis, MO 63114

vijonprofessional.com

391.000/391AA

principal display panel

germ-X

Professional

ALCOHOL FREE

FOAMING

HAND SANITIZER

Kills 99.9% of Germs

Moisturizing

128 FL OZ (1 GAL) 3.79

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND WASH 
benzalkonium chloride 0.13% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-391
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.313 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
DIGLYCERIN (UNII: 3YC120743U)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROCHLORIC ACID (UNII: QTT17582CB)
METHOXY PEG/PPG-7/3 AMINOPROPYL DIMETHICONE (UNII: 4M7P1JZ2V2)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-391-04	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/28/2016
2	NDC: 11344-391-45	1150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/28/2016
3	NDC: 11344-391-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/28/2016
4	NDC: 11344-391-46	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/28/2016
5	NDC: 11344-391-05	207 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/28/2016
6	NDC: 11344-391-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/28/2016
7	NDC: 11344-391-08	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/28/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/28/2016

Labeler - Vi-Jon, Inc (150931459)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon. nc		150931459	manufacture(11344-391)