Drugplain

Foam Hand Sanitizer 75 mL/100mL

Alcohol · LIQUID · Rubbermaid Commercial Products LLC

8 Recalls on RecordCurrently in Shortage
Plain English

Foam Hand Sanitizer is a liquid containing alcohol at 75 mL/100mL, taken topical. Manufactured by Rubbermaid Commercial Products LLC.

Key Facts

Brand Name
Foam Hand Sanitizer
Generic Name
Alcohol
NDC Code (Product)
65321-024
Manufacturer
Rubbermaid Commercial Products LLC
Strength
75 mL/100mL
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
Application #
M003
Marketing Start
05/01/2010

Recall History

8 Recalls on Record
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
Class II08/08/2022

Midlab Incorporated

CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.

TerminatedVoluntary: Firm initiated
Class III05/10/2019

Ecolab Inc

Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.

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
Class II08/08/2022

Midlab Incorporated

CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.

TerminatedVoluntary: Firm initiated
Class II02/01/2021

Kimberly-Clark Corporation

Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer

TerminatedVoluntary: Firm initiated
Class II02/06/2019

Ecolab Inc

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

TerminatedVoluntary: Firm initiated
Class II04/22/2019

Inopak Ltd

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

toxicity to various agents5,927 reports
completed suicide5,410 reports
drug abuse5,270 reports
overdose1,897 reports
death1,589 reports
intentional overdose1,542 reports
suicide attempt1,341 reports
cardio-respiratory arrest1,339 reports
somnolence905 reports
drug dependence904 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use For personal hand hygiene to help prevent the spread of bacteria.

Dosage & Administration

Directions Adults and children over 2 years, for occasional and personal domestic use. Supervise children when they use this product. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Warnings

Warnings For external use only When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation develops. Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

Frequently Asked Questions

What is Foam Hand Sanitizer used for?

Foam Hand Sanitizer contains Alcohol. It is a liquid taken topical. Consult your doctor for specific uses.

Is Foam Hand Sanitizer a controlled substance?

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

What is the generic name for Foam Hand Sanitizer?

The generic name for Foam Hand Sanitizer is Alcohol. There are 12 other brand versions of Alcohol.

What is the NDC code for Foam Hand Sanitizer 75 mL/100mL?

The NDC (National Drug Code) for Foam Hand Sanitizer 75 mL/100mL is 65321-024, listed by Rubbermaid Commercial Products LLC.