Your browser does not support JavaScript! TEARS NATURALE FORTE (DEXTRAN 70, GLYCERIN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]
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RxNorm Names

TEARS NATURALE FORTE (dextran 70, glycerin, hypromellose) solution/ drops
[Alcon Laboratories, Inc.]


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

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

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

OTC - WHEN USING SECTION

When using this product

  • remove contact lenses before using
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse or lasts 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

Directions

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

OTHER SAFETY INFORMATION

Other Information

  • store at room temperature.

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0065-0426
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextran 70 (Dextran 70) Dextran 701 mg  in 1 mL
Glycerin (Glycerin) Glycerin2 mg  in 1 mL
Hypromelloses (Hypromelloses) Hypromelloses3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Boric Acid 
Calcium Chloride 
Glycine 
Hydrochloric Acid 
Sodium Hydroxide 
Magnesium Chloride 
Polidronium Chloride 
Polysorbate 80 
Potassium Chloride 
Water 
Sodium Chloride 
Zinc Chloride 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0065-0426-2215 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/02/2003
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Laboratories, Inc.008018525MANUFACTURE(0065-0426)

Revised: 3/2009
 
Alcon Laboratories, Inc.

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