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
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/15 | Not Applicable | Recruiting | |||
2025/04/18 | Not Applicable | Recruiting | |||
2025/03/10 | Not Applicable | Recruiting | |||
2025/02/12 | Not Applicable | Recruiting | |||
2025/02/11 | Phase 1 | Recruiting | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | ||
2024/12/02 | Phase 1 | Recruiting | |||
2024/11/25 | Phase 1 | Active, not recruiting | |||
2024/10/26 | Early Phase 1 | Recruiting | |||
2024/10/04 | Not Applicable | Recruiting | |||
2024/07/29 | Phase 1 | Recruiting | Han Xi Zhao |
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 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
CHLORHEXIDINE 0.5% IN ALCOHOL 70% SOLUTION bottle | 11339 | Medicine | A | 8/13/1991 | |
ORAPLEX COLD SORE GEL | 39772 | Medicine | A | 4/27/1992 | |
NYAL MOUTH ULCER GEL tube | 16132 | Medicine | A | 10/3/1991 | |
LISTERINE TEETH DEFENCE ANTISEPTIC MOUTHWASH bottle (reformulation) | 201303 | Medicine | A | 9/25/2012 | |
AQIUM MOISTURISING absolute ethanol 70% w/w gel bottle | 410937 | Medicine | A | 6/20/2023 | |
PHARMACY SELECT BABY TEETHING GEL tube | 39770 | Medicine | A | 4/27/1992 | |
BETADINE ALCOHOLIC SKIN PREP. solution bottle | 29557 | Medicine | A | 10/25/1991 | |
DBL DEHYDRATED ALCOHOL BP Ethanol 100% Injection | 16371 | Medicine | A | 10/8/1991 | |
Chlorhexidine 1% in Ethanol 70% Tinted Blue solution bottle | 327245 | Medicine | A | 12/9/2019 | |
ORION IODINE 1% IN ALCOHOL 70% application bottle | 21232 | Medicine | A | 10/8/1991 |
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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