GENTEAL TEARS GEL DROPS- polyethylene glycol 400 and propylene glycol gel

GenTeal Tears Gel Drops by

Drug Labeling and Warnings

GenTeal Tears Gel Drops by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Alcon Research LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• 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

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

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
alcon.medinfo@alcon.com
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.

INGREDIENTS AND APPEARANCE

GENTEAL TEARS GEL DROPS 
polyethylene glycol 400 and propylene glycol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-8067
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ)	Polyethylene Glycol 400	4 mg  in 1 mL
Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3)	Propylene Glycol	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Aminomethylpropanol (UNII: LU49E6626Q)
Boric Acid (UNII: R57ZHV85D4)
Edetate Disodium (UNII: 7FLD91C86K)
Guaraprolose (3500 Mpa.S At 1%) (UNII: 3A1I7376TC)
Polidronium Chloride (UNII: 6716Z5YR3G)
Potassium Chloride (UNII: 660YQ98I10)
Sodium Chloride (UNII: 451W47IQ8X)
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-8067-01	8 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	02/04/2021

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0065-8067)