Rugby Artificial Tears by A-S Medication Solutions

Rugby Artificial Tears by

Drug Labeling and Warnings

Rugby Artificial Tears by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RUGBY ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops 
A-S Medication Solutions

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

HOW SUPPLIED

Product: 50090-2283

Polyvinyl Alcohol

RUGBY ARTIFICIAL TEARS 
polyvinyl alcohol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-2283(NDC: 0536-1084)
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-2283-0	1 in 1 CARTON	01/06/2016	12/31/2019
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	09/10/2015	12/31/2019

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-2283)

Revised: 1/2020

Document Id: 74213a80-6abe-4de0-ae97-b8cd0dfd6a85

34390-5

Set id: 24e90b70-b715-4b90-b96a-23eecaa8e4f1

Version: 6

Effective Time: 20200118

 

A-S Medication Solutions