Eye Wash by Lake Erie Medical DBA Quality Care Products LLC Drug Facts

Eye Wash by

Drug Labeling and Warnings

Eye Wash by is a Otc medication manufactured, distributed, or labeled by Lake Erie Medical DBA Quality Care Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

EYE WASH 
water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49999-241(NDC: 0904-5377)
Route of Administration	OPHTHALMIC

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49999-241-04	1 in 1 CARTON	08/31/2010	06/01/2014
1		118 mL in 1 BOTTLE, PLASTIC; 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	08/31/2010	06/01/2014

Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)

Establishment
Name	Address	ID/FEI	Business Operations
Lake Erie Medical DBA Quality Care Products LLC		831276758	relabel(49999-241)

Revised: 11/2019

Document Id: d0254e79-0e30-4b9e-bd16-5c88efa8e0cc

34390-5

Set id: 881dba22-9590-48c4-84e3-e382412bf14e

Version: 3

Effective Time: 20191113

 

Lake Er