Drugplain

Foaming Hand 1.3 mg/mL

Benzalkonium Chloride · LOTION · Cintas Corporation

10 Recalls on Record
Plain English

Foaming Hand is a lotion containing benzalkonium chloride at 1.3 mg/mL, taken topical. Manufactured by Cintas Corporation.

Key Facts

Brand Name
Foaming Hand
Generic Name
Benzalkonium Chloride
NDC Code (Product)
42961-224
Manufacturer
Cintas Corporation
Strength
1.3 mg/mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
07/20/2020

Recall History

10 Recalls on Record
Class II10/26/2018

S.C. Johnson Professional

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

TerminatedVoluntary: Firm initiated
Class II08/23/2017

Inopak Ltd

GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump

TerminatedVoluntary: Firm initiated
Class II08/15/2022

Ultra Chem Labs Corp

Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.

TerminatedN/A
Class II02/19/2024

Seatex LLC

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

TerminatedVoluntary: Firm initiated
Class II05/16/2023

Alpha Aromatics

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

TerminatedVoluntary: Firm initiated
Class II02/19/2024

Seatex LLC

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

TerminatedVoluntary: Firm initiated
Class II07/15/2022

Aire-Master of America Inc

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

TerminatedVoluntary: Firm initiated
Class II09/17/2012

DermaCare, Inc.

Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.

TerminatedVoluntary: Firm initiated
Class II07/15/2022

Aire-Master of America Inc

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

TerminatedVoluntary: Firm initiated
Class II09/17/2012

DermaCare, Inc.

Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

toxicity to various agents5,963 reports
completed suicide5,412 reports
drug abuse5,273 reports
death2,205 reports
fatigue2,134 reports
overdose2,024 reports
confusional state1,839 reports
pain1,819 reports
vomiting1,793 reports
rash1,785 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Hand sanitizer to help reduce bacteria on the skin that could cause disease Recommended for repeated use

Dosage & Administration

Directions Dispense an adequate amount of hand sanitizer Rub hands together until completely dry

Warnings

Warnings Flammable. Keep away from fire or flame. For external use only. When using this product do not use in or near eyes. If in eyes, flush thoroughly with water. If irritation or rash appears and persists, stop use and see a physician. Keep out of reach of children. If swallowed, call a physician or Poison Control Center immediately.

Adverse Reactions

If irritation or rash appears and persists, stop use and see a physician.

Frequently Asked Questions

What is Foaming Hand used for?

Foaming Hand contains Benzalkonium Chloride. It is a lotion taken topical. Consult your doctor for specific uses.

Is Foaming Hand a controlled substance?

Foaming Hand is not classified as a controlled substance by the DEA.

What is the generic name for Foaming Hand?

The generic name for Foaming Hand is Benzalkonium Chloride. There are 12 other brand versions of Benzalkonium Chloride.

What is the NDC code for Foaming Hand 1.3 mg/mL?

The NDC (National Drug Code) for Foaming Hand 1.3 mg/mL is 42961-224, listed by Cintas Corporation.