GENTEAL MODERATE TO SEVERE GEL DROPS - hypromellose and carboxymethylcellulose sodium gel 
Novartis Pharmaceuticals Corporation

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Drug Facts

Active ingredient

Carboxymethylcellulose sodium (0.25%)

Hypromellose (0.3%)

Purpose

Lubricant

Uses

• Relieves dryness of the eyes.
• Temporarily relieves discomfort due to the minor irritation 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.

Do not use if solution changes color or becomes cloudy.

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 more than 72 hours

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

Directions

Put 1 or 2 drops in the affected eye(s) as needed.

Other Information

Store between 15⁰- 30⁰C (59⁰-86⁰F).

Inactive ingredients

Boric acid, calcium chloride dihydrate, citric acid monohydrate, GenAqua (sodium perborate), magnesium chloride hexahydrate, phosphonic acid, potassium chloride, purified water, and sodium chloride

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

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

GenTeal

Moderate to Severe Dry Eye Relief

Liquid Gel Drops

Strength of a Gel,

Convenience of a Drop

Preservative Free in the Eye

USE ONLY IF TAMPER EVIDENT SEAL MARKED NOVARTIS IS INTACT.

GENTEAL  MODERATE TO SEVERE GEL DROPS hypromellose   gel

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0078-0425 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPROMELLOSE (HYPROMELLOSE) HYPROMELLOSE 0.003 L  in 1 L CARBOXYMETHYLCELLULOSE SODIUM (CARBOXYMETHYLCELLULOSE) CARBOXYMETHYLCELLULOSE SODIUM 0.0025 L  in 1 L

Inactive Ingredients Ingredient Name Strength BORIC ACID   CALCIUM CHLORIDE   CITRIC ACID MONOHYDRATE   SODIUM PERBORATE   MAGNESIUM CHLORIDE   ADEFOVIR   POTASSIUM CHLORIDE   WATER   SODIUM CHLORIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0078-0425-24 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 .015 L In 1 BOTTLE, DROPPER This package is contained within the CARTON (0078-0425-24) 2 0078-0425-16 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 2 .025 L In 1 BOTTLE, DROPPER This package is contained within the CARTON (0078-0425-16)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	09/14/2009

Labeler - Novartis Pharmaceuticals Corporation (002147023)

Revised: 09/2009Novartis Pharmaceuticals Corporation