ALCOHOL FREE ANTIBACTERIAL HAND SANITIZER- benzalkonium chloride gel 
Tekweld Solutions, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Alcohol-Free Antibacterial Hand Sanitizer Gel

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)

Label

Alcohol-Free Antibacterial Hand Sanitizer Gel 2 oz (71160-190-02)

Label2

Alcohol-Free Antibacterial Hand Sanitizer Gel 4 oz (71160-190-04)

Label3

Alcohol-Free Antibacterial Hand Sanitizer Gel 8 oz (71160-190-08)

Label4

Alcohol-Free Antibacterial Hand Sanitizer Gel 16 oz(71160-190-16)

Label5

ALCOHOL FREE ANTIBACTERIAL HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71160-190
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71160-190-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/201801/09/2022
2NDC:71160-190-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/201801/09/2022
3NDC:71160-190-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/201801/09/2022
4NDC:71160-190-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/201801/09/2022
5NDC:71160-190-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/201801/09/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/01/201801/09/2022
Labeler - Tekweld Solutions, Inc. (169803389)

Revised: 11/2022
 
Tekweld Solutions, Inc.