EYE WASH- water liquid
Total Resources International

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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Eye Wash

ACTIVE INGREDIENTS

Water 99.1%

PURPOSE

eyewash

INACTIVE INGREDIENTS:

Benzalkonium chloride, Boric acid, Sodium borate, Sodium chloride

Use:

For flushing the eye to relieve irritations, burning, stinging and itching: remove foreign body, smog, pollen or chlorinated water.

DIRECTIONS:

Twist cap in either direction to open it. Flush the affected eye. Discard after opened. Use before expiration date on bottle.

WARNINGS:

Keep out of reach of children.

To avoid contamination, do not touch tip of container to any surface. If solution changes color or becomes cloudy, do not use. Use only as directed. If swalloed, contact poison Control Center right away. Store at room temperature (35 oF - 100 oF).

Package Labeling

Label

EYE WASH
water liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55550-700
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	991 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55550-700-01	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018	02/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	01/04/2018	02/28/2021

Labeler - Total Resources International (790160535)

Revised: 12/2018

Document Id: 7e1790ac-8f0c-4190-e053-2a91aa0ad8b5

Set id: 5b585798-9817-432b-90f9-446206887083

Version: 4

Effective Time: 20181228

Total Resources International