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| Product NDC Code | 55910-577 | ||||
|---|---|---|---|---|---|
| Drug Name | Rexall sterile eye wash |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 1053429 | ||||
| Application Number | part349 | ||||
| Labeler Name | Dolgencorp Inc | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Purified water (99.05%)
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 For use with nozzle applicator. • flush the affected eye(s) as needed • control the rate of flow of solution by pressure on the bottle • do not touch dropper tip to eye When using an eye cup • rinse the cup with Eye Wash immediately before each use • avoid contamination of the rim and inside surfaces of the cup • fill the cup half full with Eye Wash Solution and apply the cup to the affected eye(s), pressing tightly to prevent spillage • tilt the head backward. Open eyelids wide and rotate eyeball to thoroughly wash the eye • rinse cup with clean water after each use • replace cap after use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients boric acid, sodium borate and sodium chloride. 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 washes the eye to help relieve • irritation • discomfort • burning • stinging • itching • loose foreign material • air pollutants (smog or pollen) • chlorinated water
Purpose
Information about the drug product’s indications for use.Purpose Eyewash
Spl product data elements
Usually a list of ingredients in a drug product.Rexall Sterile Eye Wash Eye Wash WATER WATER BORIC ACID SODIUM BORATE SODIUM CHLORIDE BENZALKONIUM 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.Principal Display Panel - carton Since 1903 Rexall™ Sterile Eye Wash Eye Irrigating Solution • Cleanses • Refreshes • Soothes • For daily or emergency eye cleansing Sterile Eye Cup Included 4 FL OZ (118 mL) carton.jpg
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 • if you have open wounds in or near the eyes, and get medical help right away • 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 swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • store at 15 o -25 o C (59 o -77 o F) • keep tightly closed • does not contain thimerosal • enclosed eyecup is sterile if packaging is intact • use before expiration date marked on the carton or bottle.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call: 1-866-4-REXALL
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 • condition worsens or persists
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 • do not touch tip of container to any surface to avoid contamination • replace cap after use
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 • if you have open wounds in or near the eyes, and get medical help right away • if solution changes color or becomes cloudy When using this product • remove contact lenses before using • do not touch tip of container to any surface to avoid contamination • 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 • condition worsens or persists Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
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