Eye Irrigating by Rugby Laboratories / Geri-Care Pharmaceuticals, Corp Rugby Eye Wash

Eye Irrigating by

Drug Labeling and Warnings

Eye Irrigating by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Geri-Care Pharmaceuticals, Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EYE IRRIGATING- purified water solution 
Rugby Laboratories

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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Rugby Eye Wash

Active ingredient

Purified water (99.05%)

Purpose

Eyewash

Uses

washes the eye to help relieve

• irritation
• stinging
• discomfort
• itching

by removing

• loose foreign material
• air pollutants (smog or pollen)
• chlorinated water

Warnings

For external use only

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

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
• you have open wounds in or near the eye. Get medical help right away.

Keep out of reach of children.

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

Directions

For use without the eye cup

• flush the affected eye(s) as needed
• control the rate of flow of solution by placing pressure on the bottle

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When using an eye cup

• rinse the cup with Eye Irrigating Solution immediately before each use
• avoid contamination of the rim and inside surfaces of the cup
• fill the cup half full with Eye Irrigating Solution 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 thoroughly wash the eye
• rinse the cup with clean water after each use

Other information

• store at room temperature 15° - 25°C (59° - 77°F)
• keep tightly closed

Inactive ingredients

boric acid, sodium borate, sodium chloride, hydrochloric acid PRESERVATIVE ADDED: edetate disodium, polyhexamethylene biguanide

Question or comments?

1-800-645-2158

Package label

Rugby

NDC: 0536-1126-97

Compare to the active ingredient in Bausch + Lomb Advanced Eye Relief® Eye Wash*

GENTLE CLEANSING SOLUTION
FOR EVERYDAY USE

Eye
Irrigating
Solution

Eases Irritation
Soothes Burning & Stinging
Relieves Itching

THIMEROSAL FREE
Isotonic

Sterile eye cup enclosed

STERILE

4 FL OZ (118 mL)

EYE IRRIGATING 
purified water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1126
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)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROCHLORIC ACID (UNII: QTT17582CB)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1126-97	1 in 1 BOX	05/01/2017	04/01/2020
1		118 mL in 1 BOTTLE; 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	05/01/2017	04/01/2020

Labeler - Rugby Laboratories (079246066)

Registrant - Geri-Care Pharmaceuticals, Corp (611196254)

Revised: 12/2018

Document Id: 7cd5c860-9144-08a7-e053-2991aa0a566c

34390-5

Set id: 4f04cd6b-1b23-2091-e054-00144ff88e88

Version: 3

Effective Time: 20181212

 

Rugby Laboratories