Active Ingredient
Purified water 93%
Eyesaline Concentrate
FDA Label NDC 64809-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sperian Eye & Face Protection Inc. for the product Eyesaline Concentrate (NDC 64809-104). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, stop use and consult a doctor if you have, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Eyewash
Uses
- For flushing or irrigating the eye to remove loose foreign material, air pollutants, or chlorinated water.
Warnings
For external use only- Obtain immidiate medical treatment for all open wounds in or near the eyes. To avoid contamination, do not touch tip of container to any surface. Replace cap after use.
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.
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 to water
- Agitate or mix thoroughly
- ​Repeat until required amount of solution is prepared
- Properly dispose of empty bottle after use
- Replace solution no longer than (6) months after mixing
Do not reuse.
Other Information
Do not freeze
Inactive Ingredients
benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic
Questions?
Call
1-800-430-5490
Sperian Eye and Face Protection Inc
(a Honeywell Company)
825 East Highway 151
Platteville, WI 53818 USA
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