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
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
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2021/06/23 | Early Phase 1 | ENROLLING_BY_INVITATION | |||
2019/09/12 | Phase 3 | Recruiting | |||
2019/04/03 | Phase 2 | Completed | |||
2018/09/05 | Phase 4 | Completed | |||
2017/11/28 | Phase 4 | Terminated | |||
2017/06/23 | Phase 3 | Completed | |||
2016/10/18 | Phase 4 | Completed | Riyadh Colleges of Dentistry and Pharmacy | ||
2016/07/14 | Phase 4 | Completed | |||
2016/06/13 | Phase 4 | Completed | |||
2015/12/08 | Phase 1 | Terminated |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
United Natural Foods, Inc | 83455-213 | OPHTHALMIC | 0.25 g in 100 mL | 1/1/2024 | |
HYDRASPHERE PLUS LLC | 85579-005 | CUTANEOUS | 1 g in 40 mL | 4/28/2025 | |
GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 84558-008 | CUTANEOUS | 4 g in 100 g | 5/7/2025 | |
STEEL CITY HEALTH PRIVATE LIMITED | 85884-025 | ORAL | 100 mg in 1 mL | 7/21/2025 | |
CorneaCare Inc | 82875-003 | OPHTHALMIC | 0.63 g in 100 mL | 8/2/2025 | |
Allergan, Inc. | 0023-4515 | OPHTHALMIC | 10 mg in 1 mL | 8/22/2025 | |
Rising Pharma Holdings, Inc. | 57237-339 | RECTAL | 2 g in 1 1 | 7/16/2025 | |
Rising Pharma Holdings, Inc. | 57237-338 | RECTAL | 1.2 g in 1 1 | 6/12/2025 | |
Neilmed Pharmaceuticals Inc. | 13709-335 | TOPICAL | 144 mg in 1 g | 6/11/2025 | |
The Kroger Co. | 30142-573 | OPHTHALMIC | 0.25 g in 100 mL | 1/1/2024 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Hyaluronic acid gel | 381373 | Honest International Pty Ltd | Medicine | A | 12/24/2021 |
Aelo | 490647 | Maebo Pty Ltd | Medicine | A | 6/3/2025 |
COLOXYL GLYCEROL SUPPOSITORIES FOR ADULTS glycerol 2.8 g strip pack | 421421 | Medicine | A | 9/7/2023 | |
Joint Rebuild | 294437 | Medicine | A | 9/28/2017 | |
QV Flare Up Cream | 252972 | Medicine | A | 8/6/2015 | |
Cooling Gel | 381374 | Honest International Pty Ltd | Medicine | A | 12/24/2021 |
Curezma Junior ECZEMA Soothing Sensitive Lotion | 449059 | Medicine | A | 5/20/2024 | |
ORAL-EZE GEL benzocaine 30mg/g cetylpyridinium chloride 100 micrograms /g, glycerol 100mg/g, ethanol 374 mg/g gel tube | 39774 | Medicine | A | 4/27/1992 | |
PETRUS GLYCEROL 2.8g SUPPOSITORIES FOR ADULTS strip pack | 12789 | Medicine | A | 8/28/1991 | |
SM33 GEL tube | 12182 | Pharmaco Australia Ltd | Medicine | A | 8/9/1991 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
TEARS NATURALE FORTE | Alcon Canada Inc | 02246397 | Solution - Ophthalmic | 0.2 % | 1/2/2003 |
AGAROL PLAIN EML | warner-lambert canada inc. | 01945971 | Emulsion - Oral | 800 MG / 5 ML | 12/31/1992 |
VISINE FOR DRY EYE EYE REVIVAL | johnson & johnson inc | 02436132 | Drops - Ophthalmic | 0.2 % / V/V | 5/19/2016 |
LUBRICANT EYE DROPS/ ARTIFICIAL TEARS | bausch & lomb inc | 02321696 | Drops - Ophthalmic | 0.3 % / W/V | 8/25/2009 |
GLYCERIN USP (LIQUID) | kolmar canada inc. | 00892076 | Liquid - Topical | 100 % | 12/31/1995 |
GLYCERINE LIQ 100% | produits marc-o (1987) inc., division of technilab inc. | 00430781 | Liquid - Oral | 100 % | 11/15/1994 |
GLYCERIN LIQUID | d.c. labs limited | 00094048 | Liquid - Oral
,
Topical | null NIL / NIL | 12/31/1951 |
HAND THERAPY CREME | beauticontrol inc. | 02246586 | Cream - Topical | 28 % | 8/1/2003 |
GLY-RECTAL SUP POUR ADULTES | lab valmo enregistré, division of technilab inc. | 00484830 | Suppository - Rectal | 91 % / SUP | 12/31/1979 |
GLYCERIN SUPPOSITORIES FOR ADULTS 90% | technilab pharma inc. | 00145416 | Suppository - Rectal | 90 % | 12/31/1978 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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Saudi SFDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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