PHYSICIANSCARE OPHTHALMIC SOLUTION EYEWASH- purified water 98.3% solution

PhysiciansCare Ophthalmic Solution Eyewash by

Drug Labeling and Warnings

PhysiciansCare Ophthalmic Solution Eyewash by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation, Niagara Pharmaceuticals, inc., Acme United Corporation Vancouver Division, Niagara Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Purified Water 98.3%

PURPOSE

Purpose

Eyewash

INDICATIONS & USAGE

Use

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

WARNINGS

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 

Stop use and ask a doctor if you experience

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

KEEP OUT OF REACH OF CHILDREN

 

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

DOSAGE & ADMINISTRATION

 

Directions

Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

INFORMATION FOR PATIENTS

 

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 INGREDIENT

 

Inactive ingredients

boric acid, sodium borate, sodium chloride

QUESTIONS

Questions?  Call   1-800-835-2263

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PHYSICIANSCARE OPHTHALMIC SOLUTION EYEWASH 
purified water 98.3% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0160(NDC:65785-160)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	929 g  in 946 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-0160-01	30 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	06/12/2013
2	NDC: 0924-0160-04	118 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	06/12/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022305	06/12/2013

Labeler - Acme United Corporation (001180207)

Registrant - Niagara Pharmaceuticals, inc. (205477792)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-0160) , repack(0924-0160)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation Vancouver Division		080119599	relabel(0924-0160) , repack(0924-0160)

Establishment
Name	Address	ID/FEI	Business Operations
Niagara Pharmaceuticals, Inc.		205477792	manufacture(0924-0160)