GENTEAL NIGHT-TIME PM - mineral oil and petrolatum ointment 
Novartis Pharmaceuticals Corporation

----------

Drug Facts

Active ingredient

Mineral oil (15%)

White petrolatum (85%)

Purpose

Lubricant

Uses

• 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

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

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(s) and apply a small amount (1/4 inch) of ointment to the inside of the eyelid(s).
• Apply one or more times daily or as directed by a doctor.
  

Other information

• Store between 15⁰- 30⁰C (59⁰-86⁰F).
• Keep tightly closed.

Questions?

call toll-free 1-866-393-6336, weekdays, 8:30 AM - 5:00 PM EST.

Serious side effects associated with use of this product may be reported to this number.

PRINCIPAL DISPLAY PANEL

PACKAGE LABELING

GenTeal

Lubricant Eye Ointment

Night-time PM Dry Eye Relief

GenTeal Night-time PM ointment delivers Advanced Hydration with a maximum concentration of moisture for long-lasting night-time comfort.

NIGHT-TIME OINTMENT

Long-Lasting Night-time Comfort

Concentrated For Lasting Relief

GENTEAL  NIGHT-TIME PM white petrolatum   ointment

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (MINERAL OIL) MINERAL OIL 0.15 g  in 1 g PETROLATUM (PETROLATUM) PETROLATUM 0.85 g  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0078-0473-97 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 3.5 g In 1 BOTTLE, DROPPER This package is contained within the CARTON (0078-0473-97)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	12/14/2009

Labeler - Novartis Pharmaceuticals Corporation (002147023)

Revised: 12/2009Novartis Pharmaceuticals Corporation