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

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 solution 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

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, 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 0078-0518-2
Mild to Moderate
Dry Eye Relief

GenTeal®
LUBRICANT EYE DROPS

LIQUID DROPS
Fast, Soothing Relief

Alcon®
STERILE 15 mL (0.5 fl oz)

GenTeal

hypromellose LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0078-0518
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HYPROMELLOSE 2910 (4000 MPA.S) 0.003 L

Inactive Ingredients

Ingredient Name Strength
BORIC ACID
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 NDC:0078-0518-24 .015 in 1 BOTTLE, DROPPER
2 NDC:0078-0518-16 .025 in 1 BOTTLE, DROPPER

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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