TEARS NATURALE FORTE - dextran 70, glycerin and hypromelloses solution/ drops 
Alcon Laboratories, Inc.

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.

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Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Dextran 70 0.1%
Glycerin 0.2%
Hypromellose 0.3%

OTC - PURPOSE SECTION

Purpose

Lubricant

INDICATIONS & USAGE SECTION

Uses

For the temporary relief of burning and irritation due to dryness of the eye and for use as a protectant against further irritation. For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

OTC - WHEN USING SECTION

When using this product

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

Directions

OTHER SAFETY INFORMATION

Other Information

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, POLYQUAD® (polyquaternium-1) 0.001% preservative, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.

OTC - QUESTIONS SECTION

Questions?

In the U.S. call 1-800-757-9195
www.tearsnaturale.com

PRINCIPAL DISPLAY PANEL

Moderate/Severe Dry Eye

NDC 0065-0426-22
Dry Eye Protection

TEARS Naturale® FORTE

LUBRICANT EYE DROPS

15 mL        
(0.5 FL OZ)
STERILE
Alcon®

Carton
TEARS NATURALE FORTE  
dextran 70, glycerin, hypromellose solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-0426
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68) Dextran 70 1 mg  in 1 mL
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin 2 mg  in 1 mL
Hypromelloses (UNII: 3NXW29V3WO) (Hypromelloses - UNII:3NXW29V3WO) Hypromelloses 3 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Boric Acid (UNII: R57ZHV85D4)  
Calcium Chloride (UNII: M4I0D6VV5M)  
Glycine (UNII: TE7660XO1C)  
Hydrochloric Acid (UNII: QTT17582CB)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Magnesium Chloride (UNII: 02F3473H9O)  
Polidronium Chloride (UNII: 6716Z5YR3G)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Potassium Chloride (UNII: 660YQ98I10)  
Water (UNII: 059QF0KO0R)  
Sodium Chloride (UNII: 451W47IQ8X)  
Zinc Chloride (UNII: 86Q357L16B)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0065-0426-22 15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 01/02/2003
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Laboratories, Inc. (008018525)
Establishment
Name Address ID/FEI Business Operations
Alcon Laboratories, Inc. 008018525 MANUFACTURE(0065-0426)

Revised: 3/2009
Document Id: 331cd37b-5826-bd74-adb7-c13167c6fb81
Set id: 3a4828de-6b1c-a10c-6e40-899b0e461e7d
Version: 1
Effective Time: 20090318
 
Alcon Laboratories, Inc.