Your browser does not support JavaScript! GENTEAL MILD TO MODERATE (HYPROMELLOSE) LIQUID [NOVARTIS PHARMACEUTICAL CORPORATION]
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GENTEAL MILD TO MODERATE (hypromellose) liquid
[Novartis Pharmaceutical Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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)

Carton
GENTEAL   MILD TO MODERATE
hypromellose liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0078-0518
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hypromellose 2910 (4000 Mpa.s) (Hypromellose 2910 (4000 Mpa.s)) Hypromellose 2910 (4000 Mpa.s)0.003 L  in 1 L
Inactive Ingredients
Ingredient NameStrength
Boric Acid 
Phosphonic Acid 
Potassium Chloride 
Water 
Sodium Chloride 
Sodium Perborate 
Hydrochloric Acid 
Sodium Hydroxide 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0078-0518-24.015 L in 1 BOTTLE, DROPPER
2NDC:0078-0518-16.025 L in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/14/2009
Labeler - Novartis Pharmaceutical Corporation (002147023)
Establishment
NameAddressID/FEIBusiness Operations
EXCELVISION AG482198285MANUFACTURE(0078-0518)

Revised: 9/2012
 
Novartis Pharmaceutical Corporation

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