FDA Label for Artificial Tears
View Indications, Usage & Precautions
Artificial Tears Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Polyvinyl Alcohol 1.4%
Purpose
Lubricant
Uses
- temporary relieve of burning and irritation due to dryness of the eye
Warnings
- Do not use if solution changes color or becomes cloudy
When Using This Product
- do not touch tip of container to any surface to avoid contamination
- you experience eye pain, changes in vision, continued redness or irritation of the eye
- condition worsens or persists for more than 72 hours
Stop use and ask a doctor if
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away
Directions
- instill 1 to 2 drops in the affected eye(s) as needed
Other Information
- store at 15° - 30°C (59° - 86°F)
- keep tightly closed
- replace cap after use
Inactive Ingredients
dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate,
purified water, sodium chloride. Phosphoric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.01%
Questions ?
Serious side effects associated with use of this product may be reported to 1800-323-0000
DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW IS NOT INTACT.
Package/Label Principal Display Panel
NDC 37205-137-05
LEADER®
Compare to Liquifilm Tears®* active ingredient*
Artificial Tears Solution
Polyvinyl Alcohol 1.4%
Lubricant Eye Drops
(Sterile)
FOR USE IN THE EYES ONLY
SATISFACTION GUARANTEED 1/2 FL. OZ. (15 mL)
* Please review the disclaimer below.