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Ethanol

Generic Name
Ethanol
Brand Names
Dalmacol, Gattex, Healing Waters Aloe Cucumber Hand Sanitizer, Healing Waters Cotton Blossom Hand Sanitizer, Healing Waters Lemon Verbena Hand Sanitizer, Healing Waters Peach Nectarine Hand Sanitizer, Lupaneta Pack 1-month, Viva-drops Lubricating Eye Drops
Drug Type
Small Molecule
Chemical Formula
C2H6O
CAS Number
64-17-5
Unique Ingredient Identifier
3K9958V90M

Overview

A clear, colorless liquid rapidly absorbed from the gastrointestinal tract and distributed throughout the body. It has bactericidal activity and is used often as a topical disinfectant. It is widely used as a solvent and preservative in pharmaceutical preparations as well as serving as the primary ingredient in alcoholic beverages.

Indication

For therapeutic neurolysis of nerves or ganglia for the relief of intractable chronic pain in such conditions as inoperable cancer and trigeminal neuralgia (tic douloureux), in patients for whom neurosurgical procedures are contraindicated.

Associated Conditions

  • Bacterial Infections
  • Obstructive Hypertrophic Cardiomyopathy
  • Skin Irritation
  • Bacterial skin infections
  • Ethylene glycol overdose
  • Fat occlusion in central venous catheter
  • Methanol overdose

Research Report

Published: Jul 29, 2025

Ethanol (DB00898): A Comprehensive Pharmacological, Toxicological, and Regulatory Monograph

I. Introduction and Compound Identification

Introduction

Ethanol, a simple two-carbon alcohol, holds a uniquely paradoxical position in science, medicine, and society. It is simultaneously a small molecule drug with specific, approved therapeutic applications, a widely consumed psychoactive substance with profound public health consequences, and a fundamental chemical feedstock indispensable to industry and laboratory practice. This monograph provides a definitive, evidence-based analysis of ethanol, reconciling its disparate identities through a rigorous examination of its pharmacology, toxicology, clinical utility, and the multifaceted regulatory frameworks that govern its use. A central theme of this report is the critical importance of context—dose, chronicity of exposure, genetic predisposition, and intended use—in defining ethanol's effects. The molecule's regulation is a prime example of this complexity, with distinct government bodies, such as the U.S. Food and Drug Administration (FDA) and the Alcohol and Tobacco Tax and Trade Bureau (TTB), exerting authority depending on whether the substance is intended for therapeutic use or human consumption as a beverage.[1] This report synthesizes a vast body of data to serve as a comprehensive reference for professionals in pharmacology, medicine, toxicology, and regulatory affairs.

Compound Identification

To establish the precise chemical entity under review, the following primary identifiers for ethanol are provided.

  • Drug Name: Ethanol [2]
  • DrugBank ID: DB00898 [2]
  • Type: Small Molecule
  • CAS Number: 64-17-5 [6]
  • Synonyms: Ethanol is known by numerous synonyms, reflecting its widespread use. These include: Ethyl Alcohol, EtOH, Grain Alcohol, Absolute Alcohol, Dehydrated Alcohol, Methylcarbinol, Ethyl Hydrate, Ethyl Hydroxide, and Alcohol, USP.[8]

II. Physicochemical Properties

Continue reading the full research report

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
STRATEGIC SOURCING SERVICES LLC
70677-0056
TOPICAL
70 mL in 100 mL
5/14/2025
Ashtel Studios, Inc.
70108-184
TOPICAL
70 mL in 100 mL
6/16/2025
Medical Chemical Corporation
12745-177
TOPICAL
59.86 g in 100 mL
7/31/2025
Guangzhou Tingcai Cosmetic Co., Ltd.
77975-016
TOPICAL
70 g in 100 mL
5/20/2025
Walgreen Company
0363-5190
TOPICAL
70 mL in 100 mL
3/21/2025
Georgia-Pacific Consumer Products LP
54622-708
TOPICAL
70 mg in 1 mL
5/12/2025
Pearl World Inc.
69933-259
TOPICAL
70 mL in 100 mL
4/29/2025
Kingkey MBC Life Technology Group Co.,Ltd
73928-099
TOPICAL
62 mL in 100 mL
7/29/2025
MELON BIO-TECH (THAILAND) CO., LTD.
85588-203
TOPICAL
62 mL in 100 mL
4/28/2025
Horizon Tool Inc.
74683-2100
TOPICAL
80 mL in 100 mL
5/1/2025

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
MARSEPT CUTANEOUS SOLUTION 2% W/V + 70% V/V
N/A
N/A
N/A
4/19/2024
CHLORHEXIDINE SOLUTION 2% W/V IN ALCOHOL 70% V/V
N/A
N/A
N/A
5/29/2020

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
SANI MED CITRUS GEL HAND SANITIZER
sani-clean systems inc.
02246511
Gel - Topical
60.25 %
8/29/2002
MEDIMAXX CITRUS
avmor ltd
02241659
Gel - Topical
60.25 %
6/15/2000
PT POWDER PT LIQUID 1 PT LIQUID 2
coralite dental products
00070262
Powder For Solution ,  Liquid - Dental
18 %
1/19/1993
CLINISHIELD INSTANT HAND SANITIZER
chester labs, inc.
02245037
Gel - Topical
62 %
3/1/2002
VIONEXUS NO-RINSE SPRAY
metrex research, llc
02243205
Liquid - Topical
65.87 %
12/11/2000
ACTIPREP
healthpoint canada ulc
02243498
Liquid - Topical (Hospital/HC Facilities)
83 %
9/12/2002
BIO-SEPTIC
bio-care laboratoires
02321416
Liquid - Topical
12.0 %
N/A
INSTANT HAND SANITIZER
scott chemical canada
02239308
Gel - Topical
62 %
3/1/2000
ALCORUB (RUBBING ALCOHOL COMPOUND)
stanley pharmaceuticals, a division of vita health products inc.
00179779
Liquid - Topical
null NIL / NIL
12/31/1965
TINCTURE OF IODINE 2.5%
rw consumer products ltd
00892084
Tincture - Topical
93.5 %
12/31/1995

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
AGUA DEL CARMEN SOLUCIÓN ORAL
Laboratorio De Aplicaciones Farmacodinamicas S.A.
27454
SOLUCIÓN ORAL
Sin Receta
Commercialized
ALCOHOL 96º SANITARIO REIG JOFRE SOLUCION CUTANEA
Laboratorio Reig Jofre, S.A.
58543
SOLUCIÓN CUTÁNEA
Sin Receta
Commercialized
ALCOHOL 70º CON CLORURO DE BENZALCONIO BETAMADRILEÑO
Laboratorios Betamadrileno S.L.
58727
SOLUCIÓN CUTÁNEA
Sin Receta
Not Commercialized
ALCOHOL 96º CON CLORURO DE BENZALCONIO SANITARIO BETAMADRILEÑO
Laboratorios Betamadrileno S.L.
58575
SOLUCIÓN CUTÁNEA
Sin Receta
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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