GenTeal description, usages, side effects, indications, overdosage, supplying and lots more!

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GenTeal

Novartis Pharmaceutical Corporation


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

OTC - ACTIVE INGREDIENT SECTION

Carboxymethylcellulose sodium (0.25%)
Hypromellose (0.3%)

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 and sun.
  • As a protectant against further irritation.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use

  • if gel changes color or becomes cloudy
  • 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

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

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

Store between 15°- 25°C (59°- 77°F).

INACTIVE INGREDIENT SECTION

Boric acid, calcium chloride dihydrate, citric acid monohydrate, magnesium chloride hexahydrate, phosphonic acid, potassium chloride, purified water, sodium chloride and sodium perborate. May contain hydrochloric acid and / or sodium hydroxide to adjust pH.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0078-0425-24
Moderate to Severe
Dry Eye Relief

GenTeal®
LUBRICANT GEL DROPS

LIQUID GEL DROPS
Strength of a Gel,
Convenience of a Drop

Alcon®
STERILE 15 mL (0.5 fl oz)

GenTeal

hypromelloses and carboxymethylcellulose sodium GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0078-0425
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HYPROMELLOSES 3 mg
CARBOXYMETHYLCELLULOSE SODIUM 2.5 mg

Inactive Ingredients

Ingredient Name Strength
BORIC ACID
calcium chloride
CITRIC ACID MONOHYDRATE
MAGNESIUM CHLORIDE
Phosphonic Acid
potassium chloride
water
SODIUM CHLORIDE
SODIUM PERBORATE
HYDROCHLORIC ACID
SODIUM HYDROXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE, DROPPER
2 25 in 1 BOTTLE, DROPPER
3 NDC:0078-0425-16 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2009-09-14


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