MedPath

Glycerin

Generic Name
Glycerin
Brand Names
Clear Eyes Cooling Comfort, Clear Eyes Redness Relief Reformulated Nov 2011, Fleet Mineral Oil, Genteal Tears, Glycerolyte 57, Pedia-lax Liquid, Preparation H Cream, Procalamine 3, Refresh Optive Advanced, Refresh Optive Extended Therapy, Synovisol, Tears Lubricant
Drug Type
Small Molecule
Chemical Formula
C3H8O3
CAS Number
56-81-5
Unique Ingredient Identifier
PDC6A3C0OX

Overview

A trihydroxy sugar alcohol that is an intermediate in carbohydrate and lipid metabolism.

Indication

It is used as a solvent, emollient, pharmaceutical agent, and sweetening agent.

Associated Conditions

  • Cold Sore
  • Constipation
  • Dry Mouth
  • Dry Skin
  • Dry throat
  • Edema of the cerebrum
  • Increase in Intracranial Pressure (ICP)
  • Occasional Constipation
  • Ocular Discomfort
  • Ocular Hypertension
  • Ocular Irritation
  • Skin Infections
  • Sore Throat
  • Mouth soreness
  • Sensation of burning in the eyes

Research Report

Published: Aug 19, 2025

A Comprehensive Monograph on Glycerin (Glycerol): Pharmacology, Clinical Applications, and Safety Profile

1.0 Introduction and Chemical Identity

1.1 Overview of Glycerin as a Polyol Compound

Glycerin, also known as glycerol, is a simple polyol compound that holds a position of fundamental importance in both biological systems and industrial processes. Structurally, it is a trihydroxy sugar alcohol, or triol, and serves as a critical intermediate in the metabolism of carbohydrates and lipids.[1] It is a naturally occurring substance, forming the structural backbone of all lipids known as glycerides.[2] In its pure form, glycerin is a clear, colorless, odorless, and viscous liquid characterized by a distinctly sweet taste.[2] These unique physicochemical properties, particularly its strong affinity for water, have led to its ubiquitous use across a vast spectrum of applications. It is a cornerstone ingredient in pharmaceutical formulations, a staple in the cosmetics and personal care industries, a versatile additive in food manufacturing, and a valuable component in numerous industrial applications.[3] Its versatility is such that it can function as an active pharmaceutical ingredient, a pharmaceutical excipient, a food additive, and an industrial chemical, making a comprehensive understanding of its properties and actions essential for a wide range of scientific and clinical disciplines.

1.2 Nomenclature and Identification

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/05/02
Phase 1
Not yet recruiting
2025/03/25
Phase 4
Completed
VZW Cardiovascular Research Center Aalst
2025/03/20
Phase 2
Not yet recruiting
2024/07/09
Phase 4
Completed
Aswan University Hospital
2023/09/21
Not Applicable
Recruiting
KK Women's and Children's Hospital
2023/04/20
Phase 4
Recruiting
2022/12/21
Phase 2
Active, not recruiting
Wills Eye
2022/12/21
Not Applicable
Completed
2022/08/11
Phase 1
Withdrawn
2021/08/24
Phase 2
UNKNOWN
Kaplan Medical Center

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Antigen Laboratories, Inc.
49288-9932
INTRADERMAL, SUBCUTANEOUS
0.1 mL in 1 mL
12/8/2009
Army and Air Force Exchange Service
55301-998
OPHTHALMIC
0.5 g in 100 mL
1/1/2024
Antigen Laboratories, Inc.
49288-9936
INTRADERMAL, SUBCUTANEOUS
0.25 mL in 1 mL
12/8/2009
Harris Teeter, LLC.
69256-979
OPHTHALMIC
0.25 g in 100 mL
1/1/2024
OASIS Medical, Inc.
42126-6400
OPHTHALMIC
0.25 g in 100 mL
9/12/2025
Antigen Laboratories, Inc.
49288-9935
INTRADERMAL, SUBCUTANEOUS
0.5 mL in 1 mL
12/8/2009
Rising Pharma Holdings, Inc.
57237-325
RECTAL
2 g in 1 1
9/8/2025
Optiq Eyecare LLC
85949-112
OPHTHALMIC
9 mg in 1 mL
9/20/2025
CVS Pharmacy
59779-109
RECTAL
2 g in 1 1
7/13/2025
Shanghai Yijing Medical Technology Co., Ltd.
85157-002
RECTAL
7.2 g in 10 mL
2/19/2025

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
GLYCEROL 2G SUPPOSITORIES FOR CHILDREN
SIN02823P
SUPPOSITORY
1.4 g
5/22/1989
MINICA S ENEMA
SIN03514P
ENEMA
12.5% w/w
6/15/1989
HUACHI ENEMA
SIN02959P
ENEMA
6 g/20 ml
5/26/1989
LEMON SWEET PURGATIVE SYRUP
SIN02748P
SYRUP
1.1%
5/9/1989
KABIVEN EMULSION FOR INFUSION
SIN11657P
INJECTION
4.3 g/1000 ml
9/4/2001
LIPOFUNDIN MCT/LCT INFUSION 20%
SIN05658P
INJECTION
25 g/1000 ml
4/8/1991

NMPA Drug Approvals

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

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
GLY-RECTAL SUP POUR ENFANTS
lab valmo enregistré, division of technilab inc.
N/A
Suppository - Rectal
91 % / SUP
12/31/1979
VISINE CONTACT LENS
johnson & johnson inc
02229483
Drops - Ophthalmic
0.2 %
8/24/1998
CLEAR EYES EXTRA STRENGTH REDNESS RELIEF
prestige brands inc
02360837
Solution - Ophthalmic
0.50 % / W/V
4/27/2011
LUBRICANT EYE DROPS
kc pharmaceuticals inc
02455579
Solution - Ophthalmic
0.2 % / W/V
N/A
DRY EYE TEARS
juno otc inc
02389886
Solution - Ophthalmic
0.2 % / W/V
2/12/2014
OPTREX EYE DROPS
schering-plough healthcare products canada, a division of schering canada inc.
02236576
Drops - Ophthalmic
1 %
8/20/1998
THERAPEUTIC HAND CREAM
e.t. browne drug co., inc.
02253399
Cream - Topical
27.6 %
N/A
OPTREX EYE DROPS
knoll pharma inc.
02185482
Drops - Ophthalmic
1 %
12/31/1996
GLYCERINUM-INJEEL LIQ (10D,30D,200D/1.1ML)
02058324
Liquid - Oral
10 D / 1.1 ML
12/31/1993
REFRESH OPTIVE FUSION SENSITIVE
02450534
Solution - Ophthalmic
1 % / W/V
4/26/2016

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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