QUALITY CHOICE EYE WASH- water solution/ drops

Quality Choice Eye Wash by

Drug Labeling and Warnings

Quality Choice Eye Wash by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Assoc., Inc., K.C. Pharmaceuticals, Inc., Bausch & Lomb Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Purified water (99.05%)

PURPOSE

Purpose

Eye wash

INDICATIONS & USAGE

Uses

washes the eye to help relieve

• irritation
• discomfort
• burning
• tinging
• 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 tip of container to any surface to avoid contamination
• replace cap after use

Stopo 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. 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 15º-25ºC (59º-77ºF)
• 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

QUALITY CHOICE EYE WASH 
water solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-841
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
SODIUM BORATE (UNII: 91MBZ8H3QO)
BORIC ACID (UNII: R57ZHV85D4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-841-04	1 in 1 CARTON	04/21/2020
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	04/21/2020

Labeler - Chain Drug Marketing Assoc., Inc. (011920774)

Registrant - K.C. Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Inc.		114406598	manufacture(63868-841)

Establishment
Name	Address	ID/FEI	Business Operations
K.C. Pharmaceuticals, Inc.		174450460	pack(63868-841) , label(63868-841)