Polyethylene glycol 400 and propylene glycol

Drug Facts label

Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

Same medicine, other brands

Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.

Companies that sell this medicine

The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.

• Alcon Laboratories, Inc.8 products
• Strategic Sourcing Services LLC5 products
• Walgreens2 products
• Target Corporation2 products
• Better Living Brands, LLC2 products
• Cardinal Health 110, LLC. DBA Leader2 products
• Chain Drug Marketing Assoc., Inc.2 products
• Cvs2 products
• Cardinal Health2 products
• Wal-Mart Stores, Inc.2 products
• Meijer Distribution, Inc.2 products
• Walgreen Company2 products
• AvPAK1 product
• NovaBay Pharmaceuticals, Inc.1 product
• OCuSOFT LLC1 product
• Publix Super Markets, Inc.1 product
• Archie's Remedies1 product
• Rite Aid Corporation1 product
• Kroger1 product
• Army and Air Force Exchange Service1 product
• KC Pharmaceuticals, Inc.1 product
• CorneaCare Inc.1 product
• CVS Pharmacy, Inc.1 product
• Harris Teeter, LLC.1 product
• Walmart, Inc.1 product
• Dolgencorp LLC1 product
• Geiss, Destin & Dunn, Inc.1 product
• Topco Assoc LLC1 product
• Alcon Research Ltd1 product

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific products or lots: check the name and lot number on your package.

1. September 11, 2026 · Class II · Ongoing · D-0009-2027

   Lack of Assurance of Sterility

   Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes) Product size: 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myl — K.C. Pharmaceuticals, Inc.

2. March 3, 2026 · Class II · Ongoing · D-0412-2026

   Lack of Assurance of Sterility

   Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) Harris — K.C. Pharmaceuticals, Inc

3. March 3, 2026 · Class II · Ongoing · D-0409-2026

   Lack of Assurance of Sterility

   Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 470 — K.C. Pharmaceuticals, Inc

4. April 23, 2025 · Class II · Ongoing · D-0407-2025

   cGMP deviations and lack of assurance of sterility.

   Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pula — BRS Analytical Services, LLC

5. November 13, 2023 · Class I · Ongoing · D-0295-2024

   Non-Sterility

   Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1 — Kilitch Healthcare India Limited

6. October 31, 2023 · Class I · Ongoing · D-0135-2024

   Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

   LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0088-1 — Cardinal Health Inc.

7. June 29, 2022 · Class II · Terminated · D-1314-2022

   CGMP Deviations: products were stored outside the drug label specifications.

   Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-04 — Mckesson Medical-Surgical Inc. Corporate Office

Next steps

• Find a pharmacy near youA pharmacist can answer questions about this label
• SystaneBrand page: products, maker and price
• GenTeal TearsBrand page: products, maker and price
• Latest FDA drug recallsPrescription and over-the-counter, newest first
• All over-the-counter medicinesSearch by ingredient, brand or Spanish name

Sources

1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
4. FDA rule for the Drug Facts label (21 CFR 201.66)

Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.

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