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| Product NDC Code | 65785-169 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Pur-wash |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||||
| Dosage Form | SOLUTION | ||||||
| RxCUI drug identifier | 1151101, 1424605 |
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| Application Number | NDA022305 | ||||||
| Labeler Name | Niagara Pharmaceuticals Inc. | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Purified water 98.3%
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 snap off ridged tamper-evident tip Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients boric acid, sodium borate, sodium chloride
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.Use For cleansing the eye to help relieve irritation or burning by removing loose foreign material
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.PUR-WASH Water BORIC ACID SODIUM CHLORIDE SODIUM BORATE WATER WATER
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 - 118 mL Bottle Label Pur-Wash Purified Water, 98.3% Ophthalmic Solution Eyewash Single Use Manufactured by: Niagara Pharmaceuticals Inc. 60 Innovation Dr. Dundas ON L9H 7P3 Made in Canada Sterile Solution 4 Fl Oz [118 mL] PDP-Drug Facts
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.Drug Facts
Manufactured by: Niagara Pharmaceuticals Inc. 60 Innovation Dr. Dundas ON L9H 7P3
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 experience any open wounds in or near the eyes and obtain immediate medical treatment 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions ? ☎ Call 973-568-3361 9 a.m. to 5 p.m. EST Mon-Fri
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 side effects occur. You may report side effects to FDA at 1-800-FDA-1088 changes in vision eye pain condition worsens or persists continued redness or irritation of the eye
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 to avoid contamination, do not touch tip of container to any surface do not reuse once opened, discard
Storage and handling
Information about safe storage and handling of the drug product.Other information lot number is printed on the bottle store at 20° to 25° C [68° to 77° F] for your protection, this bottle has an imprinted white seal with black printing "TAMPER EVIDENT SEAL" do not use if this seal is missing or broken use before expiration date marked on bottle
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 experience any open wounds in or near the eyes and obtain immediate medical treatment if solution changes color or becomes cloudy When using this product to avoid contamination, do not touch tip of container to any surface do not reuse once opened, discard Stop use and ask a doctor if side effects occur. You may report side effects to FDA at 1-800-FDA-1088 changes in vision eye pain condition worsens or persists continued redness or irritation of the eye 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