GENTEAL NIGHT-TIME PM- white petrolatum ointment

GenTeal by

Drug Labeling and Warnings

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

Drug Details [pdf]

OTC - ACTIVE INGREDIENT SECTION

Mineral oil (15%)
White petrolatum (85%)

OTC - PURPOSE SECTION

Lubricant

INDICATIONS & USAGE SECTION

• Relieves dryness of the eye.
• Temporarily relieves discomfort due to minor irritations of the eye or from exposure to wind or sun.
• As a protectant against further irritation.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

• if you are sensitive to any ingredient in this product

OTC - WHEN USING SECTION

When using this product do not touch tip of container to any surface. Replace cap after using.

OTC - STOP USE SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Store between 15°- 25°C (59°-77°F).

INACTIVE INGREDIENT SECTION

anhydrous liquid lanolin

OTC - QUESTIONS SECTION

In the U.S. call toll-free 1-866-393-6336; MedInfo@AlconLabs.com
Serious side effects associated with use of this product may be reported to this telephone number.
www.genteal.com

PRINCIPAL DISPLAY PANEL

NDC: 0078-0473-97

Night-time PM
Dry Eye Relief

GenTeal®
LUBRICANT EYE OINTMENT

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

NIGHT-TIME OINTMENT
Long-lasting Night-time Relief

Alcon®

STERILE 3.5 g (0.12 fl oz)

INGREDIENTS AND APPEARANCE

GENTEAL   NIGHT-TIME PM
white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0078-0473
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP)	Mineral Oil	0.15 g  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	0.85 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: 0078-0473-97	1 in 1 CARTON	12/14/2009	04/30/2022
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	12/14/2009	04/30/2022

Labeler - Novartis Pharmaceutical Corporation (002147023)

Establishment
Name	Address	ID/FEI	Business Operations
S.A. Alcon-Couvreur N.V.		370205429	manufacture(0078-0473)