Label: PHYSICIANSCARE OPHTHALMIC SOLUTION EYEWASH- purified water 98.3% solution
- NDC Code(s): 0924-0162-08
- Packager: Acme United Corporation
- This is a repackaged label.
- Source NDC Code(s): 65785-162
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 1, 2019
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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 have any of the following
- changes in vision
- eye pain
- condition worsens or persists
- continued redness or irritation of the eye
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INFORMATION FOR PATIENTS
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PHYSICIANSCARE OPHTHALMIC SOLUTION EYEWASH
purified water 98.3% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-0162(NDC:65785-162) 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:0924-0162-08 236 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product 06/28/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022305 06/24/2013 Labeler - Acme United Corporation (001180207) Registrant - Niagara Pharmaceuticals, Inc. (205477792) Establishment Name Address ID/FEI Business Operations Acme United Corporation 045924339 relabel(0924-0162) , repack(0924-0162) Establishment Name Address ID/FEI Business Operations Acme United Corporation Vancouver Division 080119599 relabel(0924-0162) , repack(0924-0162) Establishment Name Address ID/FEI Business Operations Niagara Pharmaceuticals, Inc. 205477792 manufacture(0924-0162)