Propylene glycol

Generic Name: Propylene glycol

Brand Names: Leader Lubricant Eye Drops, QC ultra lubricant eye, Systane, Systane Balance

Drug Type: Small Molecule

Chemical Formula: C_₃H_₈O_₂

CAS Number: 57-55-6

Unique Ingredient Identifier: 6DC9Q167V3

Overview

A clear, colorless, viscous organic solvent and diluent used in pharmaceutical preparations.

Indication

No indication information available.

Associated Conditions

Dry Eyes
Ocular Irritation

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.	2024/04/23	NCT06379685	Phase 1	Not yet recruiting	Laboratorios Sophia S.A de C.V.
Clinical and Radiographic Evaluation of Hyaluronic Acid Compared to Propylene Glycol as Vehicle for Double Antibiotic Paste in Lesion Sterilization and Tissue Repair Technique for Non-Vital Primary Molars	2021/11/11	NCT05116306	Phase 3	Not yet recruiting	Ain Shams University
Post-Operative Constipation Following Total Knee Arthroplasty	2020/05/08	NCT04380090	Phase 2	Completed	The Cleveland Clinic
Clinical Trial to Compare the Safety and Efficacy of Nanodrop®	2019/10/02	NCT04111965	Phase 1	Completed	Laboratorios Sophia S.A de C.V.
Vitamin D and Bone Homeostasis in Ortho Polytrauma Patients	2017/02/28	NCT03066817	Phase 1	Suspended	New York City Health and Hospitals Corporation
The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction	2010/09/23	NCT01207752	Not Applicable	Completed	Southern California College of Optometry at Marshall B. Ketchum University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ATORVASTATIN CALCIUM	Blenheim Pharmacal, Inc.	10544-874	ORAL	40 mg in 1 1	11/24/2015
Atorvastatin Calcium	American Health Packaging	68084-099	ORAL	40 mg in 1 1	2/3/2023
ATORVASTATIN CALCIUM	A-S Medication Solutions	50090-6506	ORAL	80 mg in 1 1	6/14/2023
Fluoxetine	Proficient Rx LP	71205-188	ORAL	N/A	11/1/2022
ATORVASTATIN CALCIUM	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8006	ORAL	10 mg in 1 1	11/10/2023
ATORVASTATIN CALCIUM	Cambridge Therapeutics Technologies, LLC	70882-109	ORAL	40 mg in 1 1	6/7/2017
Dry eye relief	CARDINAL HEALTH 110, LLC. DBA LEADER	70000-0088	OPHTHALMIC	3 mg in 1 mL	9/12/2025
ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	16714-174	ORAL	20 mg in 1 1	6/14/2023
ATORVASTATIN CALCIUM	A-S Medication Solutions	50090-6480	ORAL	10 mg in 1 1	4/28/2023
ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	16714-176	ORAL	80 mg in 1 1	6/14/2023

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
SYSTANE ULTRA LUBRICANT EYE DROPS PRESERVATIVE FREE	N/A	alcon hong kong ltd	N/A	N/A	5/21/2012

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
APOTEX-Amlodipine/Atorvastatin 10/10 amlodipine (as besilate)+atorvastatin (as ca propylene glycol solvate) 10mg/10mg film-coated tablet blister pack	214402	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/10/2014
ATORVASTATIN TIH atorvastatin (as calcium propylene glycol solvate) 20 mg film-coated tablet blister pack	384523	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/10/2022
APOTEX-Amlodipine/Atorvastatin 5/40 amlodipine (as besilate)+atorvastatin (as ca propylene glycol solvate) 5 mg/40 mg film-coated tablet blister pack	214396	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/10/2014
ATORVASTATIN SPR atorvastatin (as calcium propylene glycol solvate) 20 mg film-coated tablet blister pack	384520	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/10/2022
APOTEX-Amlodipine/Atorvastatin 10/40 amlodipine (as besilate)+atorvastatin (as ca propylene glycol solvate) 10mg/40mg film-coated tablet blister pack	214342	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/10/2014
APOTEX-Amlodipine/Atorvastatin 5/10 amlodipine (as besilate)+atorvastatin (as ca propylene glycol solvate) 5mg/10mg film-coated tablet blister pack	214400	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/10/2014
ATORVASTATIN SPR atorvastatin (as calcium propylene glycol solvate) 10 mg film-coated tablet blister pack	384518	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/10/2022
ATORVASTATIN SPR atorvastatin (as calcium propylene glycol solvate) 40 mg film-coated tablet blister pack	384521	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/10/2022
ATORVASTATIN TIH atorvastatin (as calcium propylene glycol solvate) 40 mg film-coated tablet blister pack	384527	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/10/2022
ATORVASTATIN SPR atorvastatin (as calcium propylene glycol solvate) 80 mg film-coated tablet blister pack	384519	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/10/2022

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SALINOL SOL 160MG	laboratoires charton laboratories	00779288	Spray - Nasal	200 MG / ML	12/31/1989
EPISEC LOT	odan laboratories ltd	00382302	Lotion - Topical	4 %	12/31/1976
RHINARIS NASAL GEL	pendopharm division of pharmascience inc	02352699	Gel - Nasal	20 %	11/24/2011
LUBRICANT EYE DROPS/ ARTIFICIAL TEARS	bausch & lomb inc	02321696	Drops - Ophthalmic	1 % / W/V	8/25/2009
LUBRICATING NASAL GEL	Pharmascience Inc	02220806	Gel - Nasal	20 %	1/17/1997
RHINARIS NASAL MIST	pendopharm division of pharmascience inc	02354551	Spray, Metered Dose - Nasal	5 % / W/W	1/11/2012
MANORAPID SYNERGY	remington medical equipment ltd.	02248224	Solution - Topical (Hospital/HC Facilities)	5.9 %	1/20/2004
RHINEDRINE MOISTURIZING NASAL MIST -LIQ NAS	jamieson laboratories ltd	02214792	Liquid - Nasal	4.36 %	12/11/1997
SALINEX NASAL LUBRICANT	Sandoz Canada, Inc.	01910701	Spray - Nasal	50 MG / ML	12/31/1991
LUBRICATING NASAL MIST	Pharmascience Inc	00732230	Metered-Dose Aerosol - Nasal	5 %	12/31/1988

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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