FOAMING HAND SANITIZER- benzalkonium chloride lotion

Foaming Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Use

to decrease bacteria on the skin

Warnings

for external use only

When using this product

• keep out of eyes.  In case of contact with eyes, flush thoroughly with water.
• avoid contact with broken skin

Stop use and ask a doctor if

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

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance 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

Inactive ingredients

cetrimonium chloride, diglycerin, disodium cocoamphodiacetate, fragrance, glycerin, hydrochloric acid, methoxy PEG/PPG-7/3 aminopropyl dimethicone, sodium benzoate, tetrasodium EDTA, water

Rear label text

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

Made in USA with US and foreign components

Distributed By: Vi-Jon

8515 Page Ave

St. Louis, MO 63114

www.germx.com

principal display panel

germ-X

alcohol free

foaming

hand

sanitizer

KILLS GERMS IN 15 SECONDS

Kills 99.99% of Germs

Fresh Scent

7.5 FL OZ (221 mL)

INGREDIENTS AND APPEARANCE

FOAMING HAND SANITIZER 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 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)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-118-05	207 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/05/2009
2	NDC: 11344-118-96	221 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/05/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/05/2009

Labeler - Vi-Jon (150931459)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		150931459	manufacture(11344-118)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		790752542	manufacture(11344-118)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		088520668	manufacture(11344-118)