Active Ingredient
Active ingredient Glycerin 0.5%
Regener-eyes Ophthalmic Solution Professional Strength Xl Solution/ Drops
FDA Label NDC 87354-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by M & M Products, L.l.c. for the product Regener-eyes Ophthalmic Solution Professional Strength Xl (NDC 87354-002). 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 active ingredient, purpose, indications and usage, warnings, keep out of reach of children, dosage and administration, when using, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purpose: Eye Lubricant
Indications And Usage
Uses:
For the temporary relief of burning and irritation due to dryness of the eye. For use as a lubricant to prevent further irritation or to relieve dryness of the eye. For use as a protectant against further irritation or to relieve dryness of the eye.
Indications
Regener-Eyes® is formulated to provide temporary relief of burning and irritation due to dryness of the eye. Each product is preservative-free and can be used as a protectant against further irritation or to relieve dryness of the eye.
Warnings
Warnings:
External Use Only. To avoid contamination, do not touch tip of container to any surface. Replace cap after using. If solution changes color or becomes cloudy, do not use.
Stop use and ask a doctor If:
You experience eye pain, changes in vision, continued redness, or irritation of the eye. Condition worsens or persists for more than 72 hours.
Keep out of reach of children
If swallowed, get medical help, or contact a Poison Control Center immediately.
Keep Out Of Reach Of Children
Keep out of reach of children
If swallowed, get medical help, or contact a Poison Control Center immediately.
Dosage And Administration
Directions
Instill 1 or 2 drops in the affected eye (s) as needed.
When Using
Store at Room Temperature.
Inactive Ingredients
Inactive Ingredients
Sterile Water, Tonicity Solution Sodium Chloride.
Patient Counseling
Questions?
(656) 225-2260
Package Label.Principal Display Panel
Proprietary Name: Regener-Eyes Ophthalmic Solutiion LITE XL
Product Descriptor: Eye Lubricant
Key Claims: To Relieve Dryness of the Eye
Net Contents: 5mL
* Please review the disclaimer below.
