RUGBY EYE WASH- water, purified liquid

Rugby Eye Wash by

Drug Labeling and Warnings

Rugby Eye Wash by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, KC Pharmaceuticals, Inc., Bausch & Lomb Incorporated, KC Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Purified water (99.05%)

PURPOSE

Purpose

Eyewash

INDICATIONS & USAGE

Uses

washes the eye to help relieve

• irritation
• discomfort
• burning
• stinging
• itching

by removing

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

WARNINGS

Warnings
For external use only

Do not use

• if you have open wounds in or near the eyes, and get medical help right away
• if solution changes color or becomes cloudy

When using this product

• remove contact lenses before using
• do not touch the 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

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

DOSAGE & ADMINISTRATION

Directions

For use with nozzle applicator

• flush the affected eye(s) as needed
• control the rate of flow of solution by pressure on the bottle
• do not touch dropper tip to eye

When using an eye cup

• rinse the cup with Eye Wash Solution immediately before each use
• avoid contamination of the rim and inside surfaces of the cup
• fill the cup half full with Eye Wash Solution and apply the cup to the affected eye(s), pressing tightly to prevent spillage
• tilt the head backward.  Open eyelids wide and rotate eyeball to thoroughly wash the eye
• rinse cup with clean water after each use
• replace cap after use

OTHER SAFETY INFORMATION

Other information

• Store at 15°-25°C (59°-77°F)
• keep tightly closed
• does not contain thimerosal
• enclosed eyecup is sterile if packaging is intact
• use before expiration date marked on the carton or bottle

INACTIVE INGREDIENT

Inactive ingredients

boric acid, sodium borate and sodium chloride.  PRESERVATIVE ADDED: BENZALKONIUM CHLORIDE (0.01%)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RUGBY EYE WASH 
water, purified liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1224
Route of Administration	OPHTHALMIC

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

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1224-97	1 in 1 BOX	02/22/2019
1		118 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	02/22/2019

Labeler - Rugby Laboratories (079246066)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorporated		114406598	manufacture(0536-1224)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals		174450460	pack(0536-1224) , label(0536-1224)