FIRSTEP FIRSTFLUSH- eyewash solution

Firstep Firstflush by

Drug Labeling and Warnings

Firstep Firstflush by is a Otc medication manufactured, distributed, or labeled by Encon Safety Products, Inc., Niagara Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Purified water 98.3%

Purpose

Eyewash

Warnings

For external use only

Do not use

• if you experience any open wounds in or near the eyes and obtain immediate medical treatment
• if solution changes color or becomes cloudy

When using this product

• to avoid contamination, do not touch tip of container to any surface
• do not reuse
• once opened, discard

Use

For cleansing the eye to help relieve irritation or burning by removing loose foreign material

Stop use and ask a doctor if you have any of the following

• continued redness or irritation of the eye
• condition worsens or persists
• eye pain
• changes in vision

Keep out of reach of children

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

Directions

• remove tamper evident seal and cap
• flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

Other information

• lot number is printed on the bottle
• store at 20° to 25° C [68° to 77° F]
• for your protection, this bottle has an imprinted white seal with black printing “TAMPER EVIDENT SEAL”
• do not use if this seal is missing or broken
• use before expiration date marked on bottle

Inactive ingredients

boric acid, sodium borate, sodium chloride

Questions?

☎ Call 973-227-1830 9 a.m. to 5 p.m. EST Mon-Fri

Dosage and Administration

• remove tamper evident seal and cap
• avoid contamination of rim and inside surfaces of the nozzle
• place nozzle to the affected area and tilt the bottle to pour liquid out through the nozzle
• open eyelids wide and rotate eyeball while controlling the rate of flow of solution by pressure on the bottle to ensure thorough bathing with the wash

Warnings

For external use only

Package Label.Principal Display Panel

INGREDIENTS AND APPEARANCE

FIRSTEP FIRSTFLUSH 
eyewash solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70290-310
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	465 mL  in 473 mL

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

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70290-310-32	946 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	04/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022305	04/27/2020

Labeler - Encon Safety Products, Inc. (008102410)

Registrant - Niagara Pharmaceuticals, Inc. (205477792)

Establishment
Name	Address	ID/FEI	Business Operations
Niagara Pharmaceuticals, Inc.		205477792	manufacture(70290-310)