Label: KOLLOURION EYESALVE EYEWASH- purified water 98.3% solution
- NDC Code(s): 72924-001-01
- Packager: Miracle Eye Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 65785-160
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 14, 2023
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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
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
- continued redness or irritation of the eye
- condition worsens or persists
- eye pain
- changes in vision
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
KOLLOURION EYESALVE EYEWASH
purified water 98.3% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72924-001(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:72924-001-01 1 in 1 CARTON 12/01/2020 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M018 12/01/2020 Labeler - Miracle Eye Pharmaceuticals (080055386) Establishment Name Address ID/FEI Business Operations Miracle Eye Pharmaceuticals 080055386 repack(72924-001) Establishment Name Address ID/FEI Business Operations Niagara Pharmaceuticals Inc 205477792 manufacture(72924-001)