Drugplain

Benzalkonium Chloride .13 g/1001

Antibacterial Hand Wipes · CLOTH · Quest USA Corp

10 Recalls on Record
Plain English

Benzalkonium Chloride is a cloth containing antibacterial hand wipes at .13 g/1001, taken topical. Manufactured by Quest USA Corp.

Key Facts

Brand Name
Benzalkonium Chloride
Generic Name
Antibacterial Hand Wipes
NDC Code (Product)
78691-140
Manufacturer
Quest USA Corp
Strength
.13 g/1001
Dosage Form
CLOTH
Route
TOPICAL
Marketing Status
Application #
M003
Marketing Start
03/04/2022

Recall History

10 Recalls on Record
Class I03/10/2021

Sanit Technologies, LLC dba Durisan

Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.

TerminatedVoluntary: Firm initiated
Class II04/02/2018

Diamond Wipes International, Inc.

CGMP Deviations: finished products were manufactured with poor quality water.

TerminatedVoluntary: Firm initiated
Class II08/27/2014

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

TerminatedVoluntary: Firm initiated
Class II08/06/2014

HLI dba Humphreyline Inc

Microbial Contamination of Non-Sterile Product

TerminatedVoluntary: Firm initiated
Class II01/20/2026

ACME UNITED CORPORATION

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II11/20/2018

AVKARE Inc.

Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product

TerminatedVoluntary: Firm initiated
Class II01/20/2026

ACME UNITED CORPORATION

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II10/26/2018

S.C. Johnson Professional

CGMP Deviations: Product was released to market prior to microbiological testing.

TerminatedVoluntary: Firm initiated
Class II11/26/2013

Humco Holding Group, Inc

Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.

TerminatedVoluntary: Firm initiated
Class II06/14/2012

Kimberly-Clark Corporation

Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective126 reports
drug hypersensitivity118 reports
condition aggravated114 reports
therapy non-responder113 reports
arthralgia112 reports
musculoskeletal stiffness111 reports
pain in extremity111 reports
infection110 reports
hepatotoxicity108 reports
musculoskeletal pain108 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Hand Sanitizer to help reduce bacteria on the skin Recommended for repeated use

Dosage & Administration

Directions Take wipe and rub thoroughly over all surface of both hands. Wet hands thoroughly with wipes. Rub hand together briskly to dry without wiping. Dispose of wipe. Do not flush.

Warnings

Warnings For external use only.

Frequently Asked Questions

What is Benzalkonium Chloride used for?

Benzalkonium Chloride contains Antibacterial Hand Wipes. It is a cloth taken topical. Consult your doctor for specific uses.

Is Benzalkonium Chloride a controlled substance?

Benzalkonium Chloride is not classified as a controlled substance by the DEA.

What is the generic name for Benzalkonium Chloride?

The generic name for Benzalkonium Chloride is Antibacterial Hand Wipes. There are no other listed brand versions of Antibacterial Hand Wipes.

What is the NDC code for Benzalkonium Chloride .13 g/1001?

The NDC (National Drug Code) for Benzalkonium Chloride .13 g/1001 is 78691-140, listed by Quest USA Corp.

Product NDC

78691-140

Package NDC

78691-140-04

Other Benzalkonium Chloride Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)