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| Product NDC Code | 0536-1408 | ||||
|---|---|---|---|---|---|
| Drug Name | Rugby polyvinyl alcohol 1.4% lubricating eye drops |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION/ DROPS | ||||
| RxCUI drug identifier | 142004 | ||||
| Application Number | M018 | ||||
| Labeler Name | Rugby Laboratories | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 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 benzalkonium chloride, dibasic sodium phosphate hydrate, disodium edetate hydrate, monobasic sodium phosphate dihydrate, sodium chloride, water for injection.
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 use as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun
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.Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops Polyvinyl alcohol POLYVINYL ALCOHOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE WATER BENZALKONIUM CHLORIDE EDETATE DISODIUM SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE SODIUM CHLORIDE
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.Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15mL Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15mL
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use this product if solution changes color or becomes cloudy
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 the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information keep in a dry place store at 15°-25°C (59°-77°F) store away from sources of heat or ignition
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product remove contact lenses before using to avoid contamination, do not touch tip of container to any surface replace cap after using. Keep container tightly closed.
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 For external use only Do not use this product if solution changes color or becomes cloudy When using this product remove contact lenses before using to avoid contamination, do not touch tip of container to any surface replace cap after using. Keep container tightly closed. Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
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