Overview
Polyethylene glycols (PEGs) are products made of condensed ethylene oxide and water that can contain various derivatives and have various functions. Because many PEG types are hydrophilic, they are favorably used as enhancers of penetration, and used heavily in topical dermatological preparations. PEGs, along with their many nonionic derivatives, are widely utilized in cosmetic products as surfactants, emulsifiers, cleansing agents, humectants, and skin conditioners. Polyethylene glycol 400 (PEG 400) is a low-molecular-weight grade of polyethylene glycol with a low-level toxicity. It is very hydrophilic, which renders it a useful ingredient in drug formulations to augment the solubility and bioavailability of weakly water-soluble drugs. It is used in ophthalmic solutions for the relief of burning, irritation and/or discomfort that follows dryness of the eye . PEG "400" indicates that the average molecular weight of the specific PEG is 400 . PEGylation occurs when PEGs are attached to numerous protein medications, allowing for greater solubility for selected drugs. Examples of PEGylated medications are PEG-interferon alpha (Pegintron) and PEG-filgrastim. In addition, PEG is available as a bowel preparation for colonoscopy procedures and as a laxative .
Indication
PEG-400 has been indicated for the temporary relief of burning and irritation due to dryness of the eye, andfor protection against further irritation and desiccation , , .
Associated Conditions
- Constipation
- Dry Eyes
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2008/03/03 | Phase 4 | Completed | |||
2008/02/22 | Phase 4 | Completed | |||
2007/11/30 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Discount Drug Mart, Inc. | 53943-490 | OPHTHALMIC | 1 g in 100 mL | 1/1/2024 | |
| Alcon Laboratories, Inc. | 0065-1431 | OPHTHALMIC | 4 mg in 1 mL | 7/30/2025 | |
| Cardinal Health 107, LLC | 55154-4384 | ORAL | N/A | 7/24/2019 | |
| Morning Star OTC | 53209-6001 | OPHTHALMIC | 10 mg in 1 mL | 6/16/2025 | |
| DLC Laboratories, Inc. | 24286-1575 | OPHTHALMIC | 10 mg in 1 mL | 4/18/2025 | |
| Preferred PHarmaceuticals Inc. | 68788-8635 | OPHTHALMIC | 1 g in 100 mL | 5/7/2025 | |
| Mylan Pharmaceuticals Inc. | 0378-3951 | ORAL | N/A | 12/9/2020 | |
| DLC Laboratories, Inc. | 24286-1292 | OPHTHALMIC | 4 mg in 1 mL | 4/18/2025 | |
| Bausch & Lomb Incorporated | 29943-002 | OPHTHALMIC | 2.5 mg in 1 mL | 8/20/2025 | |
| Mylan Pharmaceuticals Inc. | 0378-3952 | ORAL | N/A | 12/9/2020 |
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 |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| VISINE FOR RED EYE COOL | johnson & johnson inc | 02328399 | Drops - Ophthalmic | 1 % / V/V | 4/15/2010 |
| VISINE FOR RED EYE WORKPLACE | johnson & johnson inc | 02436086 | Drops - Ophthalmic | 1 % / W/V | 6/3/2016 |
| RED EYE WORKPLACE | johnson & johnson inc | 02518228 | Drops - Ophthalmic | 1 % / V/V | 3/15/2022 |
| ADVANCED RELIEF EYE DROPS | juno otc inc | 02344319 | Solution - Ophthalmic | 1 % / W/V | 8/30/2010 |
| VISINE TRUE TEARS - LIQUID | pfizer canada inc., consumer healthcare division | 02153610 | Liquid - Ophthalmic | 1 % | 12/31/1996 |
| VISINE COOL | johnson & johnson inc | 02144085 | Drops - Ophthalmic | 1 % | 12/31/1995 |
| LUBRICANT EYE DROPS | advanced vision research, inc. | 02428989 | Solution - Ophthalmic | 0.4 % / W/V | N/A |
| ADVANCED RELIEF EYE DROPS | kc pharmaceuticals inc | 02455293 | Solution - Ophthalmic | 1 % / W/V | N/A |
| VISINE FOR RED EYE TRIPLE ACTION | johnson & johnson inc | 02248657 | Drops - Ophthalmic | 1 % / W/V | 3/8/2005 |
| COOL EYE DROPS | Alcon Canada Inc | 02248545 | Solution - Ophthalmic | 1 % | N/A |
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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