Drugplain

Advanced Hand Sanitizer 70 mL/100mL

Ethyl Alcohol · GEL · Retail Business Services, LLC

7 Recalls on Record
Plain English

Advanced Hand Sanitizer is a gel containing ethyl alcohol at 70 mL/100mL, taken topical. Manufactured by Retail Business Services, LLC.

Key Facts

Brand Name
Advanced Hand Sanitizer
Generic Name
Ethyl Alcohol
NDC Code (Product)
72476-439
Manufacturer
Retail Business Services, LLC
Strength
70 mL/100mL
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
01/04/2021

Recall History

7 Recalls on Record
Class I06/22/2020

UVT INC

Chemical Contamination: Product contains undeclared methanol.

TerminatedVoluntary: Firm initiated
Class II06/25/2020

POLARIZED LLC

CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.

TerminatedVoluntary: Firm initiated
Class II07/11/2020

4e Brands North America, Llc

CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.

TerminatedVoluntary: Firm initiated
Class II07/11/2020

4e Brands North America, Llc

CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.

TerminatedVoluntary: Firm initiated
Class I07/11/2020

4e Brands North America, Llc

Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.

TerminatedVoluntary: Firm initiated
Class II07/11/2020

4e Brands North America, Llc

CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.

TerminatedVoluntary: Firm initiated
Class I07/11/2020

4e Brands North America, Llc

Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

toxicity to various agents5,922 reports
completed suicide5,410 reports
drug abuse5,271 reports
overdose1,895 reports
death1,586 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

Hand sanitizer to help reduce bacteria on the skin. For use when soap and water are not available. usage section

Dosage & Administration

Dosage and Administration Section

Warnings

Warning Section

Frequently Asked Questions

What is Advanced Hand Sanitizer used for?

Advanced Hand Sanitizer contains Ethyl Alcohol. It is a gel taken topical. Consult your doctor for specific uses.

Is Advanced Hand Sanitizer a controlled substance?

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

What is the generic name for Advanced Hand Sanitizer?

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

What is the NDC code for Advanced Hand Sanitizer 70 mL/100mL?

The NDC (National Drug Code) for Advanced Hand Sanitizer 70 mL/100mL is 72476-439, listed by Retail Business Services, LLC.