Medication Guide App

GenTeal Severe

Dosage form: gel
Ingredients: HYPROMELLOSE 2910 (4000 MPA.S) .003g in 1g
Labeler: Novartis Pharmaceuticals Corporation
NDC Code: 0078-0429

Disclaimer: 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 Facts

Active ingredient

Hypromellose (0.3%)

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 irritations.

Warnings

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

Do not use if gel 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 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

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

Other information

Store between 15⁰- 30⁰C (59⁰-86⁰F).

Inactive ingredients

carbopol 980, GenAqua (sodium perborate), phosphonic acid, purified water, sodium hydroxide, and sorbitol.

Questions?

call toll-free 1-866-393-6336, weekdays, 8:30 AM - 5:00 PM EST.  Serious side effects associated with the 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

Severe Dry Eye Relief

Lubricant Eye Gel

GEL

Long-lasting, Powerful Relief

Preservative Free in the Eye

USE ONLY IF TAMPER EVIDENT SEAL MARKED NOVARTIS IS INTACT.



GENTEAL  SEVERE
hypromellose gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0078-0429
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).003 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM PERBORATE 
PHOSPHORIC ACID 
WATER 
SODIUM HYDROXIDE 
SORBITOL 
Packaging
#Item CodePackage Description
1NDC:0078-0429-971 TUBE (TUBE) in 1 CARTON
13.5 g in 1 TUBE
2NDC:0078-0429-471 TUBE (TUBE) in 1 CARTON
210 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/14/2009
Labeler - Novartis Pharmaceuticals Corporation (002147023)

Revised: 11/2010
 
Novartis Pharmaceuticals Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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