ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops 
Cardinal Health

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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Artificial Tears Solution Drug Facts

Active ingredient

Polyvinyl Alcohol 1.4%

Purpose

Lubricant

Uses

Warnings

 

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

Other information

 

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

Carton

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)

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

Revised: 11/2011
Document Id: 6e60afeb-8e96-48e1-82d1-6f6c354f2ef6
Set id: 6e60afeb-8e96-48e1-82d1-6f6c354f2ef6
Version: 1
Effective Time: 20111116
 
Cardinal Health