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| Product NDC Code | 50268-678 | ||||
|---|---|---|---|---|---|
| Drug Name | Polyvinyl alcohol |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION/ DROPS | ||||
| RxCUI drug identifier | 142004 | ||||
| Application Number | M018 | ||||
| Labeler Name | AvPAK | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Polyvinyl Alcohol 1.4%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Shake well before use instill 1 to 2 drops in the affected eye(s) as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, purified water, sodium chloride. Phosphoric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.01%
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.Purpose Lubricant
Spl product data elements
Usually a list of ingredients in a drug product.Polyvinyl Alcohol Polyvinyl Alcohol EDETATE DISODIUM SODIUM PHOSPHATE, MONOBASIC SODIUM CHLORIDE WATER BENZALKONIUM CHLORIDE POLYVINYL ALCOHOL POLYVINYL ALCOHOL SODIUM PHOSPHATE, DIBASIC
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package/Label Principal Display Panel 15
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information Store at room temperature 15-30C (59-86F) Do No Use if imprinted seal on cap is torn, broken or missing Discard 90 days after opening Retain outer carton for full product information
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions ? Call 1-855-361-3993 Distributed by: AvKARE Pulaski, TN 38478 www.avkare.com Rev. 12/2022 AV 12/2022
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API