FDA Label for Genteal Tears Gel Drops
View Indications, Usage & Precautions
Genteal Tears Gel Drops Product Label
The following document was submitted to the FDA by the labeler of this product Alcon Laboratories, Inc.. 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.
Otc - Purpose
| Active Ingredients | Purpose |
| Polyethylene Glycol 400 0.4% | Lubricant |
| Propylene Glycol 0.3% | Lubricant |
Uses
- for the temporary relief of burning and irritation due to dryness of the eye
- for use as a protectant against further irritation or to relieve dryness of the eye
Warnings
For external use only
Do Not Use
- if this product changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
When Using This Product
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
Otc - Stop Use
Stop use and ask a doctor if you experience any of the following:
- eye pain
- changes in vision
- continued redness or irritation of the eye
- condition worsens or persists for more than 72 hours
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- shake well before using
- put 1 or 2 drops in the affected eye(s) as needed
Other Information
- store at room temperature
Inactive Ingredients
Aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and /or sodium hydroxide to adjust pH.
Questions?
In the U.S. call
1-800-757-9195
[email protected]
www.genteal.com
Alcon Laboratories Inc.
Fort Worth, TX 76134 USA
Made in the USA from domestic and imported materials
300038472-0920
TOP OF THE CARTON
GenTeal® Tears
LUBRICANT EYE DROPS
Severe Day + Night
DRY EYE SYMPTOM RELIEF GEL DROPS
Principal Display Panel
Severe Day + Night
DRY EYE SYMPTOM RELIEF GEL DROPS
GenTeaL® Tears
LUBRICANT EYE DROPS
GEL DROPS
Strength of a Gel,
Convenience of a drop
STERILE
Alcon 8ml (0.3 FL OZ)
TAMPER EVIDENT:
For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.
GENTEAL® TEARS Gel Drops contains two lubricants to deliver the relief of a gel with the comfort and convenience of a drop.
* Please review the disclaimer below.