HYPOTEARS- polyvinyl alcohol and polyehtylene glycol 400 solution/ drops 
Novartis Pharmaceutical Corporation

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

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl alcohol (1%)
Polyethylene glycol 400 (1%)

OTC - PURPOSE SECTION

Lubricant

INDICATIONS & USAGE SECTION

  • For use as a lubricant to relieve dryness of the eye.
  • Temporarily relieves burning and irritation due to dryness of the eye or from exposure to wind or sun.
  • Helps protect against further eye irritation.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

  • if solution changes colors or becomes cloudy
  • if you are allergic to any ingredients

OTC - WHEN USING SECTION

When using this product do not touch tip of container to any surface to avoid contamination.
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
  • condiiton worsens or persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the 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

Benzalkonium chloride 0.1 mg/mL (preservative), dextrose, edetate disodium, and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjut 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 number.

PRINCIPAL DISPLAY PANEL

STERILE
NDC 0078-0519-24

HypoTears®
Lubricant Eye Drops

"Comforting Care for Dry Eye"

15 mL (0.5 fl oz)

Alcon®

Carton
HYPOTEARS 
polyvinyl alcohol and polyehtylene glycol 400 solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0078-0519
Route of Administration OPHTHALMIC
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Polyvinyl Alcohol (UNII: 532B59J990) (Polyvinyl Alcohol - UNII:532B59J990) Polyvinyl Alcohol 10 mg  in 1 mL
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ) Polyethylene Glycol 400 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Dextrose (UNII: IY9XDZ35W2)  
Edetate Disodium (UNII: 7FLD91C86K)  
Water (UNII: 059QF0KO0R)  
Hydrochloric Acid (UNII: QTT17582CB)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0078-0519-24 1 in 1 CARTON 07/01/2005 12/11/2018
1 15 mL in 1 BOTTLE, DROPPER; 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 07/01/2005 12/11/2018
Labeler - Novartis Pharmaceutical Corporation (002147023)
Establishment
Name Address ID/FEI Business Operations
Bausch & Lomb Incorporated 079587625 manufacture(0078-0519)

Revised: 12/2018
Novartis Pharmaceutical Corporation