TEARS Naturale FORTE by Alcon Laboratories, Inc. / Alcon Research Ltd Drug Facts

TEARS Naturale FORTE by

Drug Labeling and Warnings

TEARS Naturale FORTE by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Alcon Research Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TEARS NATURALE FORTE- dextran 70, glycerin, hypromellose 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

• Active Ingredients: Purpose
• Dextran 70 0.1%: Lubricant
• Glycerin 0.2%: Lubricant
• Hypromellose 0.3%: Lubricant

Uses

• For the temporary relief of burning and irritation due to dryness of the eye
• For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

Warnings

For external use only

Do not use

• if this solution changes color or becomes cloudy

• if you are sensitive to any ingredient in this product

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

Stop use and ask a doctor

if you experience any of the following:

• eye pain
• changes in vision
• continued redness of 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 at room temperature

Inactive ingredients

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

Questions?

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

PRINCIPAL DISPLAY PANEL

Moderate/Severe Dry Eye

Dry Eye Protection

TEARS Naturale® FORTE
LUBRICANT EYE DROPS

15mL
(0.5 FL OZ)  

STERILE
Alcon®

TEARS NATURALE FORTE 
dextran 70, glycerin, hypromellose solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-5050
Route of Administration	OPHTHALMIC

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: 0065-5050-15	1 in 1 CARTON	01/02/2003	12/17/2019
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0065-5050-30	1 in 1 CARTON	01/02/2003	12/17/2019
2		30 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	01/02/2003	12/17/2019

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0065-5050)

Revised: 12/2019

Document Id: ed038408-3e88-4536-8881-350c978f87a7

34390-5

Set id: ca4d2c43-632d-447d-89bb-4809a3c13f41

Version: 2

Effective Time: 20191226

 

Alcon Laboratories, Inc.