GENTEAL TEARS NIGHT-TIME- mineral oil, white petrolatum ointment

GenTeal by

Drug Labeling and Warnings

GenTeal by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., S.A. Alcon-Couvreur N.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

PURPOSE

• Active ingredients: Purpose
• Mineral oil 3 %: Lubricant
• White petrolatum 94 %: Lubricant

Uses

• for use as a lubricant to prevent further irritation
• to relieve dryness of the eye.

Warnings

For external use only

Do not use

• if you are sensitive to any ingredient in this product

When using this product

• do not touch tip of container to any surface
• replace cap after using

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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

Other information

store at 8° – 27° C (46° – 80° F).

Inactive ingredient:

Anhydrous liquid lanolin

Questions?

In the U.S., call toll-free 1-800-757-9195
(Mon-Fri 9AM-5PM CST)
alcon.medinfo@alcon.com

PRINCIPAL DISPLAY PANEL

Severe
DRY EYE SYMPTOM RELIEF 

OINTMENT

GenTeal®
Tears

LUBRICANT EYE OINTMENT

GenTeal® Night-time PM ointment provides long-lasting relief for night-time comfort.

NIGHT-TIME OINTMENT
Long-lasting Night-time Relief

STERILE 3.5 g (0.12 FL OZ)

Alcon®

TAMPER EVIDENT:
For your protection, use only if cap and necking are intact at time of purchase.

Distributed by:
ALCON LABORATORIES, INC.,
6201 South Freeway
Fort Worth, Texas 76134 USA
Country of Origin: Belgium

787130-1218

LOT:
EXP.:

Please read this carton carefully and keep for future reference.

INGREDIENTS AND APPEARANCE

GENTEAL   TEARS NIGHT-TIME
mineral oil, white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-0518
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP)	Mineral Oil	0.03 g  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	0.94 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Lanolin (UNII: 7EV65EAW6H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-0518-01	1 in 1 CARTON	08/01/2019
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	08/01/2019

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
S.A. Alcon-Couvreur N.V.		370205429	manufacture(0065-0518)