RUGBY ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops

Rugby Artificial Tears by

Drug Labeling and Warnings

Rugby Artificial Tears by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                               Purpose

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

PURPOSE

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

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

- replace cap after each use

ASK DOCTOR

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

Keep out of reach of children

- if swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

- instill 1 to 2 drops in the affected eye(s) as needed

STORAGE AND HANDLING

Other information

- store at 15° - 25°C (59° - 77°F)

- keep tightly closed

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

Distributed by:

Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

www.rugbylaboratories.com

Rugby Laboratories

Made in Korea

Relabeled By: Preferred Pharmaceuticals Inc.

NDC: 68788-6354-01 15 ml bottle

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RUGBY ARTIFICIAL TEARS 
polyvinyl alcohol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-6354(NDC:0536-1084)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	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: 68788-6354-1	15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	03/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	03/01/2016

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-6354)