Drugplain

Ethyl Alcohol .67 mL/mL

Ethyl Alcohol · SOLUTION · Georgia-Pacific Consumer Products LP

10 Recalls on Record
Plain English

Ethyl alcohol is a topical solution applied to the skin, commonly used as an antiseptic and disinfectant to help prevent infection of minor cuts and wounds. It is available over-the-counter without a prescription.

Key Facts

Brand Name
Ethyl Alcohol
Generic Name
Ethyl Alcohol
NDC Code (Product)
54622-015
Manufacturer
Georgia-Pacific Consumer Products LP
Strength
.67 mL/mL
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
07/03/2017

Recall History

10 Recalls on Record
Class II07/30/2020

Albek De Mexico S.A. De C.V.

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

OngoingVoluntary: Firm initiated
Class I11/30/2021

Aroma Release Technologies Inc

Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol

TerminatedVoluntary: Firm initiated
Class III04/01/2019

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

TerminatedVoluntary: Firm initiated
Class I12/06/2021

Valisa MFG LLC

Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol

TerminatedVoluntary: Firm initiated
Class III04/01/2019

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

TerminatedVoluntary: Firm initiated
Class II07/23/2020

Real Clean Distribuciones SA de CV

CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

TerminatedVoluntary: Firm initiated
Class III04/01/2019

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

TerminatedVoluntary: Firm initiated
Class I05/12/2021

Global Sanitizers LLC

Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.

OngoingVoluntary: Firm initiated
Class II05/12/2021

Global Sanitizers LLC

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

OngoingVoluntary: Firm initiated
Class II01/28/2022

AMS Packaging Inc

Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.

OngoingVoluntary: 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 abuse5,270 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

Uses For handwashing to decrease bacteria on the skin. Recommended for repeated use.

Dosage & Administration

Directions Wet hands thoroughly with product and allow to dry without wiping.

Warnings

Warnings Flammable, keep away from fire or flame For external use only. Do not use in the eyes. Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Ethyl Alcohol used for?

Ethyl alcohol is a topical solution applied to the skin, commonly used as an antiseptic and disinfectant to help prevent infection of minor cuts and wounds. It is available over-the-counter without a prescription.

Is Ethyl Alcohol a controlled substance?

Ethyl Alcohol is not classified as a controlled substance by the DEA.

What is the generic name for Ethyl Alcohol?

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

What is the NDC code for Ethyl Alcohol .67 mL/mL?

The NDC (National Drug Code) for Ethyl Alcohol .67 mL/mL is 54622-015, listed by Georgia-Pacific Consumer Products LP.