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| Product NDC Code | 0536-1325 | ||||
|---|---|---|---|---|---|
| Drug Name | Rugby lubricating 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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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 (preservative), disodium edetate, purified water, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
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 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 Lubricating Drops Polyvinyl Alcohol POLYVINYL ALCOHOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED BENZALKONIUM CHLORIDE EDETATE DISODIUM WATER SODIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM HYDROCHLORIC ACID SODIUM HYDROXIDE
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.Principal Display Panel Rugby® NDC 0536-1325-94 Polyvinyl Alcohol 1.4% Lubricating Eye Drops Relieves Dryness of the Eye Sterile 0.5 FL OZ (15 mL) 1.4% carton
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 • RETAIN CARTON FOR FULL DRUG FACTS INFORMATION
TAMPER EVIDENT Do not use if tape seals on carton top and bottom flaps are damaged or missing. Distributed by: RUGBY LABORATORIES Livonia, MI 48152 www.rugbylaboratories.com Made in India Code: MH/DRUGS/28-KD/283 #302600 Rev. 03/21 R-169 Re-order No. 302600
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 reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions & comments? Call 1-800-645-2158
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 lens 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 lens 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
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