ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops

Artificial Tears by

Drug Labeling and Warnings

Artificial Tears by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Bausch & Lomb Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Polyvinyl Alcohol 1.4%

Purpose

Lubricant

Uses

• temporary relieve of burning and irritation due to dryness of the eye

Warnings

• Do not use if solution changes color or becomes cloudy

 

When using this product  

• do not touch tip of container to any surface to avoid contamination

Stop use and ask a doctor if

• you experience eye pain, changes in vision, continued redness or 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

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

Other information

• store at 15° - 30°C (59° - 86°F)
• keep tightly closed
• replace cap after use

 

Inactive ingredients

dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate,

purified water, sodium chloride. Phosphoric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.01%

Questions ?

Serious side effects associated with use of this product may be reported to 1800-323-0000

DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW IS NOT INTACT.

Package/Label Principal Display Panel

NDC: 37205-137-05

LEADER®

Compare to Liquifilm Tears®* active ingredient*

Artificial Tears Solution

Polyvinyl Alcohol 1.4%

Lubricant Eye Drops

(Sterile)

FOR USE IN THE EYES ONLY

SATISFACTION GUARANTEED 1/2 FL. OZ. (15 mL)

INGREDIENTS AND APPEARANCE

ARTIFICIAL TEARS 
polyvinyl alcohol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-137
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)	POLYVINYL ALCOHOL	14 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-137-05	15 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	11/15/2011

Labeler - Cardinal Health (097537435)

Registrant - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorporated		807927397	MANUFACTURE