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Artificial Tears

Rugby Laboratories Inc.
Bausch & Lomb Incorporated

Artificial Tears Solution Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Polyvinyl Alcohol 1.4%

Purpose

Lubricant

Artificial Tears Uses

  • relieves dryness of the eye
  • prevents further irritation

Warnings

  • Do not use if solution changes color or becomes cloudy
  • with contact lenses

When using this product  

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after use

Stop use and ask a doctor if

  • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • condition worsens or lasts for more than 72 hours

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.

Artificial Tears Other information

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

 

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 or comments?

Call 1-800-645-2158

9 am - 5 pm ET, Monday-Friday.

Serious side effects associated with use of this product may be reported to this number

Rugby ®

Duluth, GA 30097

Package/Label Principal Display Panel

Artificial Tears

NDC 0536-1970-72

Rugby®

COMPARED TO ACTIVE INGREDIENTS IN LIQUIFILM® TEARS*

Artificial Tears Solution

Polyvinyl Alcohol 1.4%

Lubricant Eye

Drops (Sterile)

Prevents irritation and relieves Dryness of the eye

Rugby®

1/2 fl oz (15 mL)

Artificial Tears

Polyvinyl Alcohol SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0536-1970
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POLYVINYL ALCOHOL 14 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC
EDETATE DISODIUM
sodium phosphate, monobasic
SODIUM CHLORIDE
water
benzalkonium chloride

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-1970-72 15 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2011-10-07


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Be sure to consult your doctor before taking any medication!
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