Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 84388a75-9d11-48ce-bf5a-88f0580d2d03
Route
OPHTHALMIC
Published
Effective Date 2021-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 400 (4 mg) Propylene Glycol (3 mg)
Inactive Ingredients
Aminomethylpropanol Boric Acid Edetate Disodium Guaraprolose (3500 Mpa.s At 1%) Polidronium Chloride Potassium Chloride Sodium Chloride Sorbitol Water Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-04

Description

Active Ingredients Purpose Polyethylene Glycol 400 0.4%           Lubricant Propylene Glycol 0.3% Lubricant


Medication Information

Description

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
Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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
Section 55105-1
Active Ingredients Purpose
Polyethylene Glycol 400 0.4%           Lubricant
Propylene Glycol 0.3% Lubricant
Warnings

For external use only

Directions
  • shake well before using
  • put 1 or 2 drops in the affected eye(s) as needed
Do Not Use
  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
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

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.

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.

When Using This Product
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Structured Label Content

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
Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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
Section 55105-1 (55105-1)
Active Ingredients Purpose
Polyethylene Glycol 400 0.4%           Lubricant
Propylene Glycol 0.3% Lubricant
Warnings

For external use only

Directions
  • shake well before using
  • put 1 or 2 drops in the affected eye(s) as needed
Do Not Use (Do not use)
  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
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

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (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.

Principal Display Panel (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.

When Using This Product (When using this product)
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)