EYE WASH- water solution 
Lake Erie Medical DBA Quality Care Products LLC

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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Drug Facts

Active ingredient

Purified water (99.05%)

Purpose

Eyewash

Uses

washes the eye to help relieve

•
irritation
•
stinging
•
itching;

by removing

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

Warnings

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

Keep out of reach of children.

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

Directions

•
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 clean water immediately before each use
•
avoid contamination of the rim and inside surfaces of the cup
•
fill the cup half full 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 ensure thorough bathing with the wash or lotion
•
rinse the cup with clean water after each use

Other information

•
store at 15º–30ºC (59º–86ºF)
•
keep tightly closed

Inactive ingredients

Boric acid, sodium borate and sodium chloride. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: edetate disodium 0.025% and sorbic acid 0.1%.

Questions?

Serious side effects associated with use of this product may be reported to: 1-800-323-0000

6782803

CT07025

DISTRIBUTED BY

MAJOR PHARMACEUTICALS

31778 ENTERPRISE DRIVE

LIVONIA, MI 48150 USA

©Major Pharmaceuticals

Rev. 11/10

Re-Order No. 700194

Image of Label

Image of Label

EYE WASH 
water solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49999-241(NDC:0904-5377)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER99.05 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49999-241-041 in 1 CARTON08/31/201006/01/2014
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34908/31/201006/01/2014
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIBusiness Operations
Lake Erie Medical DBA Quality Care Products LLC831276758relabel(49999-241)

Revised: 11/2019
Document Id: d0254e79-0e30-4b9e-bd16-5c88efa8e0cc
Set id: 881dba22-9590-48c4-84e3-e382412bf14e
Version: 3
Effective Time: 20191113
 
Lake Erie Medical DBA Quality Care Products LLC