Bortek Foaming Hand Sanitizer (BZK)

Bortek Foaming Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

BORTEK FOAMING HAND SANITIZER- benzalkonium chloride liquid 
Bortek Industries

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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Bortek Foaming Hand Sanitizer (BZK)

Drug Facts

Active ingredient

Benzalkonium chloride 0.1% w/w

Purpose

Antiseptic

Uses

• Handwash to decrease bacteria on the skin that can potentially cause disease.
• Recommended for repeated use.

Warnings

For external use only.

When using this product, keep away from eyes. In case of contact, rinse eyes with water.

Stop use and ask a doctor if irritation 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

• Pump sufficient amount of foam into palm of hand.
• Rub foam thoroughly over all surfaces of both hands, including the area under the fingernails
• Allow to dry without wiping

Inactive ingredients

Cetrimonium chloride, lautrimonium chloride, phenoxyethanol, stearalkonium chloride, water.

800.626.7835

BortekShop.com

Distributed by Bortek Industries, Inc., Mechanicsburg, PA 17055

Bortek® INDUSTRIES, INC.

Alcohol Free | Benzalkonium chloride 0.1% Antiseptic

FOAMING HAND SANITIZER

33.8 fl oz (1000 mL)

BORTEK FOAMING HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81731-403
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81731-403-01	1000 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/12/2021	02/21/2022
2	NDC: 81731-403-11	1000 mL in 1 POUCH; Type 0: Not a Combination Product	04/12/2021	10/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/12/2021	02/21/2022

Labeler - Bortek Industries (014184014)

Revised: 2/2023

Document Id: f5163275-0f8e-8c5a-e053-2a95a90ad7c3

34390-5

Set id: bfcd5cb8-1030-9274-e053-2a95a90aba7e

Version: 3

Effective Time: 20230219