Eye Wash: Package Insert and Label Information

EYE WASH- water solution/ drops
Hi-Tech Pharmacal Co., 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.

Active ingredient

Purified Water 98%

Purpose

Eye Irrigation

Keep Out of Reach of Children

If swallowed, get medical help or contact a PoisonControlCenter right away.

Uses

cleans the eyes to help relieve irritation, burning, stinging and itching
remove loose foreign material, air pollutants, or chlorinated water

Warnings

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Do Not Use

if you have an opened wound in or near the eyes; obtain medical treatment right away
if solution changes color or becomes cloudy

When using this product

to avoid contamination, do not touch tip of container to any surface
replace cap after use

Stop use and ask a doctor if

you experience eye pain or changes in vision
redness or irritation continues
condition worsens or persists

Directions

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

Inactive Ingredients

boric acid, sodium borate, sodium chloride. Preserved with edetate disodium 0.025% & sorbic acid 0.1%.

Questions or comments?

Call 1(800) 262-9010 Mon. — Thurs. 9 am — 4:30 pm EST, Fri. 9 am — 2:30 pm EST, Serious side effects associated with use of this product may be reported to this number.

Package/Label Principal Display Panel

carton image
(click image for full-size original)

THIMEROSAL FREE

STERI OPTICS

EYE WASH

STERILE ISOTONIC BUFFERED SOLUTION

Gentle Cleansing Solution for Everyday Use

√ Ease Irritation

√ Soothes Burning and Stinging

√Relieves Itching

4 FL. OZ. (118 mL)

EYE WASH
eye wash solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50383-018
Route of Administration INTRAOCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 980 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BORIC ACID
SODIUM BORATE
SODIUM CHLORIDE
EDETATE DISODIUM
SORBIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50383-018-04 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (50383-018-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 01/06/1997
Labeler — Hi-Tech Pharmacal Co., Inc. (117696873)
Registrant — Akorn Operating Company LLC (117693100)
Establishment
Name Address ID/FEI Operations
Hi-Tech Pharmacal Co., Inc. 117696873 MANUFACTURE (50383-018)

Revised: 10/2020 Hi-Tech Pharmacal Co., Inc.

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