ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops
Rugby 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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Artificial Tears Solution Drug Facts

Active ingredient

Polyvinyl Alcohol 1.4%

Purpose

Lubricant

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

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

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

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	Item Code (Source)	NDC:0536-1970
Route of Administration	OPHTHALMIC

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-1970-72	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2011	02/28/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	10/07/2011	02/28/2019

Labeler - Rugby Laboratories Inc. (079246066)

Revised: 9/2019

Document Id: 1e880f7f-7f00-4b57-b4af-f262476e1df2

Set id: f748f053-ba30-4b5b-acb8-e7d81e72c43e

Version: 2

Effective Time: 20190906

Rugby Laboratories Inc.