Drug Labeling and Warnings

Drug Details [pdf]

RUGBY EYE IRRIGATING- purified water solution/ drops 
Preferred Pharmaceuticals 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

Purified water (99.05%).................................Eyewash

Uses

washes the eye to help relieve

- irritation

- stinging

- itching

by removing

- loose foreign material

- air pollutants (smog or pollen)

- chlorinated water

Warnings

Do not use

if solution changes color or becomes cloudy

When using this product

- remove contact lenses before using

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

- replace cap after use

- you experience eye pain, changes in vision, continued redness or irritation of the eye

- condition worsens or persists

- you have open wounds in or near the eye

Keep out of reach of children. If swalloed, get medical help or contact a Poison Control Center right away.

Directions

- flush the affected eye(s) as needed

- control the rate of flow of solution by placing pressure on the bottle

When using an eye cup

- rinse the cup with clean water immediately before each use

- avoid contamination of the rim and inside surfaces of the cup

- fill the cup half full and apply the cup to the affected eye(s), pressing tightly to prevent the escape of the liquid

- tilt the head backward. Open eyelids wide and rotate eyeball to ensure thorough bathing with the wash or lotion

- rinse the cup with clean water after each use

Other Information

- store at 15° - 25°C (59° - 77°F)

- keep tightly closed

Inactive ingredients

boric acid, edetate disodium, sodium borate, sodium chloride, sodium hydroxide and sorbic acid

Distributed by:

Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

www.rugbylaboratories.com

© Rugby Laboratories

Made in Korea

NDC: 68788-6385-1

Relabeled By: Preferred Pharmaceuticals Inc.

RUGBY EYE IRRIGATING 
purified water solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-6385(NDC: 0536-1083)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	99.05 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-6385-1	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2016	09/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	05/04/2016	09/16/2019

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-6385)

Revised: 9/2019

Document Id: c1a86905-a8a0-45eb-9a07-c77208563fe0

34390-5

Set id: 52448d34-623e-4685-ad64-901e03e9f2dc

Version: 4

Effective Time: 20190916

 

Preferred Pharmaceuticals Inc.