Drugplain

Antiseptic 1 mg/mL

benzethonium chloride · SOLUTION · MPM Medical, LLC

10 Recalls on Record
Plain English

Antiseptic is a solution containing benzethonium chloride at 1 mg/mL, taken topical. Manufactured by MPM Medical, LLC.

Key Facts

Brand Name
Antiseptic
Generic Name
benzethonium chloride
NDC Code (Product)
66977-032
Manufacturer
MPM Medical, LLC
Strength
1 mg/mL
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
Application #
M003
Marketing Start
06/01/1997

Recall History

10 Recalls on Record
Class II02/24/2023

Ecometics, Inc.

CGMP DEVIATIONS

TerminatedVoluntary: Firm initiated
Class II09/11/2024

Zhejiang Jingwei Pharmaceutical Co., Ltd.

Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.

OngoingVoluntary: Firm initiated
Class I02/14/2023

Nanomaterials Discovery Corporation

Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.

OngoingVoluntary: Firm initiated
Class II01/20/2026

ACME UNITED CORPORATION

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II01/20/2026

ACME UNITED CORPORATION

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II08/18/2020

GRUPO YACANA MEXICO SAS DE CV

cGMP Deviations

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 I03/03/2022

Tennessee Technical Coatings, Corp.

Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.

TerminatedVoluntary: Firm initiated
Class II06/03/2020

WALKER EMULSIONS INC

Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.

TerminatedVoluntary: Firm initiated
Class I03/10/2021

PNHC, LLC.

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

completed suicide8,217 reports
toxicity to various agents7,738 reports
drug abuse6,927 reports
death3,102 reports
fatigue3,035 reports
pain2,856 reports
rash2,823 reports
confusional state2,747 reports
off label use2,703 reports
joint swelling2,680 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Drug Facts Box OTC-Indications & Usage Section for hand-washing to decrease bacteria on the skin

Dosage & Administration

Drug Facts Box OTC-Dosage & Administration Section wet hands and forearms apply 5 milliliters (teaspoonful) or palmful to hands and forearms scrub thoroughly for 1 minute and rinse

Warnings

Drug Facts Box OTC-Warnings Section For external use only

Frequently Asked Questions

What is Antiseptic used for?

Antiseptic contains benzethonium chloride. It is a solution taken topical. Consult your doctor for specific uses.

Is Antiseptic a controlled substance?

Antiseptic is not classified as a controlled substance by the DEA.

What is the generic name for Antiseptic?

The generic name for Antiseptic is benzethonium chloride. There are 12 other brand versions of benzethonium chloride.

What is the NDC code for Antiseptic 1 mg/mL?

The NDC (National Drug Code) for Antiseptic 1 mg/mL is 66977-032, listed by MPM Medical, LLC.