EYS EYE WASH- water solution
Eyes-Plus 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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EyS Eye Wash

Drug Facts

Active Ingredient

Purified water 98%

Purpose

Eyewash

Indications

For flushing the eyes to help relieve irritation, discomfort, burning, stinging, or itching by removing loose foreign material and air pollutants (smog or pollen).

Warnings

For external use only

To avoid contamination, do not touch tip of bottle to any surface
Do not reuse
Discard bottle after use

Do not use

If solution changes color or becomes cloudy
With contact lenses
If bottle is open or seal is broken

Stop use and consult a doctor if you experience

Eye pain
Changes in vision
Continued redness or irritation of the eye or if the condition worsens or persists

Obtain immediate medical treatment for all open wounds in or near the eyes.

Keep out of reach of children.

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

Directions

To pour - hold bottle securely, twist off top to remove
Control rate of flow by pressure on the bottle
Flush the affected eye(s) as needed
Do not touch bottle tip to eye
If necessary, continue flushing with emergency eyewash or shower.

Inactive Ingredients

Benzalkonium chloride, edetate disodium dihydrate, sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate.

Questions or Comments?

Call: (424) 263-5294

Store at 59 - 86°F (15 - 30°C)

PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label

Tamper-evident cap: Do not use if twist-off top is broken or missing -Single use only

Eyes-PlusLLC

EyS

NDC 57349-913-16

Sterile Buffered Isotonic Solution

Eye Wash

Cleans, Refreshes & Soothes

Product Code: EyS-16
16 fl oz (480ml)

Principal Display Panel - 480 ml Bottle Label

EYS EYE WASH
water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57349-913
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R)	Water	0.98 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Benzalkonium chloride (UNII: F5UM2KM3W7)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium chloride (UNII: 451W47IQ8X)
Sodium Phosphate, Dibasic, Heptahydrate (UNII: 70WT22SF4B)
Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57349-913-16	496 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2013	08/31/2019
2	NDC:57349-913-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2013	08/31/2018
3	NDC:57349-913-31	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2013	01/31/2018
4	NDC:57349-913-41	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2013	08/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part349	03/01/2013	08/31/2019

Labeler - Eyes-Plus LLC (078751656)

Revised: 11/2018

Document Id: 06199643-ca24-4815-8ed1-488790dc8bd2

Set id: 90c6a551-d1fe-41f4-aac7-30cd8db9672f

Version: 5

Effective Time: 20181129

Eyes-Plus LLC