Active Ingredient
Purified water (99.05%)
Leader Eye Wash Solution
FDA Label NDC 70000-0018
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Leader Eye Wash (NDC 70000-0018). 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, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Eyewash
Uses
washes the eye to help relieve
- irritation
- discomfort
- burning
- stinging
- itching
- loose foreign material
- air pollutants (smog or pollen)
- chlorinated water
by removing
Warnings
For external use only
Do Not Use
- if you have open wounds in or near the eyes, and get medical help right away
- if solution changes color or becomes cloudy
When Using This Product
- remove contact lenses before using
- do not touch tip of container to any surface to avoid contamination
- replace cap after use
Stop Use And Ask A Doctor If
- you experience eye pain, changes in vision, continued redness or irritation of the eye
- condition worsens or persists
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact Poison Control Center right away.
Directions
For use with nozzle applicator.
- flush the affected eye(s) as needed
- control the rate of flow of solution by pressure on the bottle
- rinse the cup with Eye Wash Solution immediately before each use
- avoid contamination of the rim and inside surfaces of the cup
- fill the cup half full with Eye Wash Solution and apply the cup to affected eye(s), pressing tightly to prevent spillage
- tilt the head backward. Open eyelids wide and rotate eyeballs to thoroughly wash the eye
- rinse cup with clean water after each use
- replace cap after use
do not touch dropper tip to eye
When using an eye cup
Other Information
- store at 15°-25°C (59°-77°F)
- keep tightly closed
- does not contain thimerosal
- enclosed eyecup is sterile if packaging is intact
- use before expiration date marked on the carton or bottle
Inactive Ingredients
boric acid, sodium borate and sodium chloride.
PRESERVATIVE ADDED: benzalkonium chloride (0.01%)
Questions Or Comments?
Toll free Product Information or to Report a Serious Side Effect Associated with use of this product Call: 1-888-527-4276
* Please review the disclaimer below.
