Polyvinyl Alcohol
Polyvinyl Alcohol is an FDA drug label for the active ingredient POLYVINYL ALCOHOL manufactured by AvPAK administered by OPHTHALMIC. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260707.
- Generic name
- POLYVINYL ALCOHOL
- Manufacturer
- AvPAK
- Product type
- HUMAN OTC DRUG
- Route
- OPHTHALMIC
- Dosage form
- N/A
- NDC
- 50268-678
- Application
- M018
- Label effective
- 20260707
About this product
Polyvinyl Alcohol is an FDA-registered drug product whose active ingredient is POLYVINYL ALCOHOL. It is labelled by AvPAK taken by ophthalmic and marketed as a human otc drug product. Identifiers on file: NDC 50268-678, application M018, label effective 20260707. It is one of 2 FDA drug label records sharing the active ingredient POLYVINYL ALCOHOL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing POLYVINYL ALCOHOL are most often described in connection with: temporary relief, burning irritation, discomfort due, eye exposure, wind sun, protectant against. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses for the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun may be used as a protectant against further irritation
Dosage & Administration
Directions Shake well before use instill 1 to 2 drops in the affected eye(s) as needed
Warnings
Warnings Do not use if solution changes color or becomes cloudy When using this product Avoid contamination, do not touch tip of container to any surface. Replace cap after use Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye the condition worsens or persists for more than 72 hours
More products with the same ingredient
POLYVINYL ALCOHOLHow products containing POLYVINYL ALCOHOL compare
FDA lists 2 drug label records with POLYVINYL ALCOHOL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | A-S Medication Solutions | 1 |
| — | — | AvPAK | 1 |
| — | — | — | — |
| — | — | — | — |
| — | — | — | — |
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0002-2027 | Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47008 3; b) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428, NDC 24385-006-05; d) Good Sense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-110-01; e) Medic'c Choice, Sterile 0.5 fl. oz. (15 mL), Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-008-01; f) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; g) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; I) Walgreens, DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015, UPC 3 11917 06503 8; J) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7. | K.C. Pharmaceuticals, Inc. | Class II | Ongoing | 20261014 |
| D-0416-2026 | Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; b) Good Sense, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-110-01; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-006-05; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; e) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47008 3; f) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7; g) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; h) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14 | K.C. Pharmaceuticals, Inc | Class II | Ongoing | 20260408 |
| D-0408-2025 | Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15. | BRS Analytical Services, LLC | Class II | Ongoing | 20250514 |
| D-0176-2025 | Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15 | AvKARE | Class III | Ongoing | 20250108 |
| D-0308-2024 | Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-2254-3 | Kilitch Healthcare India Limited | Class I | Ongoing | 20240214 |
Frequently asked questions
What is Polyvinyl Alcohol used for?
Uses for the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun may be used as a protectant against further irritation
Who makes Polyvinyl Alcohol?
AvPAK is the labeler of record for Polyvinyl Alcohol. 2 FDA label records share the active ingredient POLYVINYL ALCOHOL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does Polyvinyl Alcohol come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Polyvinyl Alcohol prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing POLYVINYL ALCOHOL?
Yes. 2 FDA drug label records list POLYVINYL ALCOHOL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has Polyvinyl Alcohol been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.