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Product NDC Code | 70290-310 | ||||
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Drug Name | Firstep firstflush |
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Type | Brand | ||||
Active Ingredients |
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Route | OPHTHALMIC | ||||
Dosage Form | SOLUTION | ||||
RxCUI drug identifier | 1151101, 2360610 |
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Application Number | NDA022305 | ||||
Labeler Name | Encon Safety Products, 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.Dosage and Administration remove tamper evident seal and cap flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle Dosage and Administration remove tamper evident seal and cap 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.Firstep Firstflush Eyewash BORIC ACID SODIUM BORATE SODIUM CHLORIDE 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.Package Label.Principal Display Panel Encon
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Dosage and Administration remove tamper evident seal and cap flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor if you have any of the following continued redness or irritation of the eye condition worsens or persists eye pain changes in vision
Firstep Firstflush: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.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
Instructions for use
Information about safe handling and use of the drug product.Directions remove tamper evident seal and cap flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle
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 973-227-1830 9 a.m. to 5 p.m. EST Mon-Fri
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
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