RUGBY 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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Active ingredient                                                               Purpose

Polyvinyl Alcohol 1.4%...................................................Lubricant

Uses

- relieves dryness of the eye

- prevents further irritation

Do not use

- if solution changes color or becomes cloudy

- with contact lenses

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

- replace cap after each 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 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° - 25°C (59° - 77°F)

- keep tightly closed

Inactive ingredients

benzalkonium chloride, dibasic sodium phosphate hydrate, edetate disodium hydrate, monobasic sodium phosphate dihydrate, purified water, sodium chloride

Distributed by:

Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

www.rugbylaboratories.com

Rugby Laboratories

Made in Korea

image description

RUGBY ARTIFICIAL TEARS 
polyvinyl alcohol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1084
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL14 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1084-941 in 1 CARTON09/10/201510/31/2020
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/10/201510/31/2020
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 7/2019
Document Id: 8d7fd341-4ab3-3e62-e053-2a95a90a3c99
Set id: 556e7de7-e0ae-4ddb-a190-599238355443
Version: 2
Effective Time: 20190712
 
Rugby Laboratories, Inc.