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| Product NDC Code | 0498-0101 | ||||
|---|---|---|---|---|---|
| Drug Name | Eyesaline emergency eyewash concentrate |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | CONCENTRATE | ||||
| RxCUI drug identifier | 2282753 | ||||
| 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 (before dilution) Purified Water 70%
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 prepare sufficient quantity of constituted eyewash solution in advance of an emergency when preparing solution, wear protective eyewear and gloves and follow sanitary procedures prepare eyewash solution by diluting 1 part concentrate to 60 parts of potable water as follows: measure 1/3 of required amount of potable water into mixing container of eyewash unit to this, add 1/3 of required amount of concentrate agitate or mix thoroughly repeat two more times until required amount of solution is prepared discard prepared solution after 6 months
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 the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination
Purpose
Information about the drug product’s indications for use.Purpose Emergency eyewash
Spl product data elements
Usually a list of ingredients in a drug product.Eyesaline Emergency Eyewash Concentrate Water SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM CHLORIDE EDETATE DISODIUM BENZALKONIUM CHLORIDE WATER WATER SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
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.Honeywell DO NOT USE IF SEAL IS BROKEN OR MISSING eyesaline® EMERGENCY EYEWASH CONCENTRATE When mixed according to directions, Eyesaline Concentrate and water will provide a buffered, preserved saline solution for flushing or irrigating the eyes. MUST BE DILUTED 32 fl. oz. (946 mL) Distributed by Honeywell Safety Products USA, Inc. Smithfield, RI, 02917 Emergency Eyewash
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
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.Ask a doctor if you have eye pain changes in vision reddness or irritation of the eye after use an injury caused by an alkali
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
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 1-800-430-5490
Storage and handling
Information about safe storage and handling of the drug product.Other information do not freeze
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 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 Ask a doctor if you have eye pain changes in vision reddness or irritation of the eye after use an injury caused by an alkali 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