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Product NDC Code | 0498-0601 | ||||||
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Drug Name | Eyesaline concentrate |
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Type | Brand | ||||||
Active Ingredients |
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Route | OPHTHALMIC | ||||||
Dosage Form | LIQUID | ||||||
Application Number | M018 | ||||||
Labeler Name | Honeywell Safety Products USA, Inc | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Purified water 93%
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 Concentrate must be diluted (1) part concentrate to (10) parts potable water before use Prepare sufficient quantity of constituted eyewash solution in advance of an emergency Mix concentrate with potable water to prepare eyewash solution as follows: Determine quantity of eyewash solution required Follow sanitary procedures Wear protective eyewear and gloves Pour 1/3 of required amount of potable water into mixing container or eyewash unit Add 1/3 of required amount of concentrate into water Agitate or mix thoroughly Repeat until required amount of solution is prepared Properly dispose of empty bottle after use Do not reuse. Replace solution no longer than (6) months after mixing
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic
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 flushing or irrigating the eye to remove loose foreign material, air pollutants, or 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.Eyesaline Concentrate Water SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM CHLORIDE EDETATE DISODIUM BENZALKONIUM 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 Eyesaline Concentrate
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 in concentrated form while wearing contact lenses if solution changes color or becomes cloudy for injection in intraocular surgery internally if eye is lacerated or object is embedded if seal is broken
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 Do not freeze
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-430-5490 Sperian Eye and Face Protection Inc (a Honeywell Company) 825 East Highway 151 Platteville, WI 53818 USA
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 consult a doctor if you have changes in vision continued reddness, irritation or pain, or if the condition worsens or persists
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- Obtain immidiate medical treatment for all open wounds in or near the eyes. Do not use in concentrated form while wearing contact lenses if solution changes color or becomes cloudy for injection in intraocular surgery internally if eye is lacerated or object is embedded if seal is broken Stop use and consult a doctor if you have changes in vision continued reddness, irritation or pain, or if the 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