Artificial Tears Solution Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

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.

----------

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

Carton

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-1970
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED14 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-1970-7215 mL in 1 BOTTLE; Type 0: Not a Combination Product10/07/201102/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34910/07/201102/28/2019
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.