ISOPTO TEARS- hypromellose 2910 solution

Isopto Tears by

Drug Labeling and Warnings

Isopto Tears 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]

ACTIVE INGREDIENT

• Active Ingredients: Purpose
• Hypromellose 2910 0.5%: Lubricant

Uses

• for the temporary relief of burning and irritation due to dryness of the eye
• for use as a protectant against further irritation

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 contacts lenses before using
• to avoid contamination, do not touch tip of container to any surface
• 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 or irritation
• 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

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

Other information

• store at room temperature.

Inactive ingredients

benzalkonium chloride 0.01% as preservative, dibasic sodium phosphate, monobasic sodium phosphate, purified water, sodium chloride, sodium citrate

Questions?

In the U.S. call 1-800-757-9195

PRINCIPAL DISPLAY PANEL

Alcon®

Isopto® Tears
LUBRICANT
Eye Drops


For Relief of
Dry Eyes Symptoms

STERILE
15 mL (1/2 FL OZ)

INGREDIENTS AND APPEARANCE

ISOPTO TEARS  
hypromellose 2910 solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0998-0408
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)	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Sodium Phosphate, Dibasic (UNII: GR686LBA74)
Sodium Phosphate, Monobasic (UNII: 3980JIH2SW)
Water (UNII: 059QF0KO0R)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Citrate (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0998-0408-15	15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/30/1990

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	09/30/1990

Labeler - Alcon Laboratories, Inc. (008018525)

Registrant - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0998-0408)