EYESALINE EMERGENCY EYEWASH CONCENTRATE- water concentrate

Eyesaline Emergency Eyewash Concentrate by

Drug Labeling and Warnings

Eyesaline Emergency Eyewash Concentrate by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc, Honeywell Safety Products USA, Inc. (fka Sperian). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (before dilution)

Purified Water 70%

PURPOSE

Purpose

Emergency eyewash

INDICATIONS & USAGE

Uses

for flushing the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination

WARNINGS

Warnings

For external use only.

Do not use

• in concentrated form
• while wearing contact lenses
• if solution changes color or becomes cloudy
• for injection
• in intraocular surgery
• internally
• if eye is lacerated or object is embedded

Ask a doctor if you have

• eye pain
• changes in vision
• reddness or irritation of the eye after use
• an injury caused by an alkali

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• prepare sufficient quantity of constituted eyewash solution in advance of an emergency
• when preparing solution, wear protective eyewear and gloves and follow sanitary procedures
• prepare eyewash solution by diluting 1 part concentrate to 60 parts of potable water as follows:
• measure 1/3 of required amount of potable water into mixing container of eyewash unit
• to this, add 1/3 of required amount of concentrate
• agitate or mix thoroughly
• ​repeat two more times until required amount of solution is prepared
• discard prepared solution after 6 months

STORAGE AND HANDLING

Other information do not freeze

INACTIVE INGREDIENT

Inactive ingredients benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

QUESTIONS

Questions? Call 1-800-430-5490

PRINCIPAL DISPLAY PANEL

Honeywell
DO NOT USE IF SEAL IS BROKEN OR MISSING
eyesaline®
EMERGENCY EYEWASH CONCENTRATE
When mixed according to directions, Eyesaline Concentrate and water will provide a buffered, preserved saline solution for flushing or irrigating the eyes.
MUST BE DILUTED
32 fl. oz. (946 mL)
Distributed by Honeywell Safety Products USA, Inc. Smithfield, RI, 02917

INGREDIENTS AND APPEARANCE

EYESALINE EMERGENCY EYEWASH CONCENTRATE 
water concentrate

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-0101
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0101-05	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part349	03/05/2020

Labeler - Honeywell Safety Products USA, Inc (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc.		167518617	manufacture(0498-0101)