REGENER-EYES OPHTHALMIC SOLUTION PROFESSIONAL STRENGTH XL- glycerin ophthalmic solution solution/ drops

Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XL by

Drug Labeling and Warnings

Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XL by is a Otc medication manufactured, distributed, or labeled by M & M PRODUCTS, L.L.C.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active ingredient Glycerin 0.5%

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

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

INGREDIENTS AND APPEARANCE

REGENER-EYES OPHTHALMIC SOLUTION PROFESSIONAL STRENGTH XL 
glycerin ophthalmic solution solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87354-002
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87354-002-01	1 in 1 CARTON	02/01/2026
1		1 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	02/01/2026

Labeler - M & M PRODUCTS, L.L.C. (959745410)

Establishment
Name	Address	ID/FEI	Business Operations
M & M PRODUCTS, L.L.C.		959745410	manufacture(87354-002)