ALCOHOL FREE ANTIBACTERIAL HAND SANITIZER- benzalkonium chloride gel

Alcohol Free Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Alcohol Free Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Tekweld Solutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.10%

Purpose

Antimicrobial

Uses

For hand washing to decrease bacteria on the skin

Warnings

For external use only.

Avoid contact with eyes. In case of contact with eyes, flush thoroughly with water.

Stop use and ask doctor

if skin irritation and redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For adults and children 2 years and older. Apply about a thumbnail size amount on palms and rub hands thoroughly until dry.

Inactive Ingredients

Water (Aqua), Glycerin, Hydroxyethylcellulose, Allantoin, Disodium EDTA.

Drug Questions:

877-254-2281

Alcohol-Free Antibacterial Hand Sanitizer Gel 1 oz (

71160-190-01)

Alcohol-Free Antibacterial Hand Sanitizer Gel 2 oz (

71160-190-02)

Alcohol-Free Antibacterial Hand Sanitizer Gel 4 oz (

71160-190-04)

Alcohol-Free Antibacterial Hand Sanitizer Gel 8 oz (

71160-190-08)

Alcohol-Free Antibacterial Hand Sanitizer Gel 16 oz(

71160-190-16)

INGREDIENTS AND APPEARANCE

ALCOHOL FREE ANTIBACTERIAL HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71160-190
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71160-190-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018
2	NDC: 71160-190-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018
3	NDC: 71160-190-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018
4	NDC: 71160-190-08	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018
5	NDC: 71160-190-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/01/2018

Labeler - Tekweld Solutions, Inc. (029077754)

Establishment
Name	Address	ID/FEI	Business Operations
Tekweld Solutions, Inc.		029077754	repack(71160-190)