Available Formats

• ACTIVE INGREDIENT

  Active ingredient	Purpose
  Hypromellose 0.3%.	Lubricant

  ---

• Uses

  • relieves dryness of the eye.
  • temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun.
  • as a protectant against further irritation.
    

  ---

• Warnings

  For external use only

  ---

• Do not use

  • if gel changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product

  ---

• When using this product

  • do not touch tip of container to any surface
  • replace cap after using

  ---

• STOP USE

  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

  
  

  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 15º - 25ºC (59º - 77ºF)

  ---

• Inactive ingredients

  carbopol 980, phosphoric acid, purifed water, sodium hydroxide, sodium perborate, and sorbitol

  ---

• Questions?

  In the U.S., call toll-free 1-800-757-9195 (Mon-Fri 9AM-5PM CST).
  alcon.medinfo@alcon.com

  ---

• PRINCIPAL DISPLAY PANEL

  NDC 0078-0429-47
  GEL
  
  Severe
  DRY EYE SYMPTOM RELIEF
  
  GenTeal Tears
  
  GEL
  
  Delivers Long-lasting relief of dry eye symptoms
  
  New Design
  
  STERILE
  
  10 g (0.34 FL OZ)
  
  TAMPER EVIDENT: For your protection, use only if pull tab is intact at time of purchase.
  
  Distributed by:
  ALCON LABORATORIES, INC.
  6201 South Freeway
  Fort Worth, Texas 76134 USA
  a Novartis Company
  Country of Origin: Switzerland
  © 2016 Novartis
  
  US 25355200
  
  LOT/EXP
  

  

  NDC 0078-0429-47
  
  Severe DRY EYE SYMPTOM RELIEF
  
  GenTeal® Tears
  LUBRICANT EYE GEL
  
  GEL
  
  Delivers long-lasting relief of dry eye symptoms
  
  STERILE 10 g (0.34 FL OZ)
  
  Active ingredient: Hypromellose (0.3%)
  Uses: See carton for Uses.
  Warnings: See carton for Warnings. When using this product do not touch tip of container to any surface. Replace cap after using.
  Directions: Put 1 or 2 drops in the affected eye(s) as needed.
  Other information: Store between 15°- 25°C (59°- 77°F).
  
  TAMPER EVIDENT: For your protection, use only if pull tab is intact at the time of purchase.
  
  US15025500
  
  Distributed by:
  ALCON LABORATORIES, INC., a Novartis company
  6201 South Freeway, Fort Worth, Texas 76134 USA
  
  © 2016 Novartis
  
  Alcon®
  
  EXP
  LOT
  
  
  
  
  

  

  
  
  

  ---

• INGREDIENTS AND APPEARANCE

  GENTEAL  SEVERE hypromellose gel

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0078-0429 Route of Administration OPHTHALMIC

  Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) (HYPROMELLOSE 2910 (4000 MPA.S) - UNII:RN3152OP35) HYPROMELLOSE 2910 (4000 MPA.S) .003 g  in 1 g

  Inactive Ingredients Ingredient Name Strength SODIUM PERBORATE (UNII: Y52BK1W96C)   PHOSPHORIC ACID (UNII: E4GA8884NN)   WATER (UNII: 059QF0KO0R)   SODIUM HYDROXIDE (UNII: 55X04QC32I)   SORBITOL (UNII: 506T60A25R)

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0078-0429-97 1 in 1 CARTON 09/14/2009 02/28/2015 1 3.5 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0078-0429-47 1 in 1 CARTON 09/14/2009 2 10 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:0078-0429-57 2 in 1 CARTON 09/14/2009 3 10 g in 1 TUBE; Type 0: Not a Combination Product

  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)

  Establishment
  Name	Address	ID/FEI	Business Operations
  Akorn AG		482198285	manufacture(0078-0429)

  Establishment
  Name	Address	ID/FEI	Business Operations
  Excelvision		274234566	manufacture(0078-0429)

  ---