Collyrium For Fresh Eyes – Eye Wash: Package Insert and Label Information

COLLYRIUM FOR FRESH EYES — EYE WASH- water solution
Bausch & Lomb Incorporated

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.

Active ingredient

Purified water (99.05%)

Purpose

eyewash

Uses

washes the eye to help relieve

irritation
discomfort
stinging
itching

by removing

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

Warnings

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

do not touch tip of container to any surface to avoid contamination
remove contact lenses before using
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

Keep out of reach of children.

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

Directions

Bottle tip permits use with or without cup.

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

When using an eye cup

rinse the cup with Collyrium Eye Wash immediately before each use
avoid contamination of the rim and inside surfaces of cup
fill the cup half full with Collyrium Eye Wash 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 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 ingredients

Boric acid, sodium borate and sodium chloride.

PRESERVATIVE ADDED: benzalkonium chloride (0.01%).

Questions or comments?

Toll Free Product Information or to Report a Serious Side Effect Associated with use of the product

Call: 1-800-553-5340

6574509

Package/Label Principal Display Panel

Collyrium for Fresh Eyes Carton
(click image for full-size original)

Soothing Collyrium

for

FRESH

EYES

EYE WASH

Soothes
Refreshes
Cleanses

Consumer Preferred Cup Design

Convenient Sterile Eye

Cup Enclosed

Sterile

4 FL. OZ. (118mL)

Oversized Carton

COLLYRIUM FOR FRESH EYES — EYE WASH
water solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24208-073
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 99.05 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
BORIC ACID
SODIUM BORATE
SODIUM CHLORIDE
BENZALKONIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24208-073-84 118 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 08/31/2010
Labeler — Bausch & Lomb Incorporated (196603781)
Establishment
Name Address ID/FEI Operations
Bausch & Lomb Incorporated 114406598 MANUFACTURE (24208-073)
Establishment
Name Address ID/FEI Operations
Bausch & Lomb Incorporated 079587625 MANUFACTURE (24208-073)

Revised: 12/2018 Bausch & Lomb Incorporated

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