Otc - Active Ingredient
Active Ingredient
Purified Water 98.3%
Kollourion Eyesalve Eyewash Solution
FDA Label NDC 72924-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Miracle Eye Pharmaceuticals for the product Kollourion Eyesalve Eyewash (NDC 72924-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
- to avoid contamination, do not touch tip of container to any surface
- do not reuse
- once opened, discard
- 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
When using this product
Stop use and ask a doctor if
Otc - 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
Other Safety Information
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
Otc - Questions
Call 1-973-568-3361 9am to 5pm EST
Package Label.Principal Display Panel
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