FDA.reportPublic FDA data

Regener-Eyes Ophthalmic Solution PROFESSIONAL

Manufacturer
M & M PRODUCTS, LLC
Effective date
2026-01-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:35:50

Label at a glance#

ProductRegener-Eyes Ophthalmic Solution PROFESSIONAL
Active ingredientGLYCERIN
Label structure10 sections

Dosage and administration

Directions: Instill 1 or 2 drops in the affected eye (s) as needed.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Glycerin 0.5%

Purpose

OTC - PURPOSE SECTION

Purpose: Eye Lubricant

Indications & Usage

INDICATIONS & USAGE SECTION

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 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 SECTION

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 asl 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

If swallowed, get medical help, or contact a Poison Control Center immediately

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions:

Instill 1 or 2 drops in the affected eye (s) as needed.

When Using

OTC - WHEN USING SECTION

Store at Room Temperature.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Sterile Water, Tonicity Solution Sodium Chloride.

Patient Counseling

PATIENT COUNSELING INFORMATION

Questions?

(656) 225-2260

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROFESSIONAL 3mL ArtWorkPROFESSIONAL 3mL ArtWork

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2540675glycerin 0.5 % Ophthalmic SolutionPSN1
2609932Regener-Eyes 0.5 % Ophthalmic SolutionPSN1
2609932glycerin 5 MG/ML Ophthalmic Solution [Regener-Eyes]SBD1
2540675glycerin 5 MG/ML Ophthalmic SolutionSCD1
2540675glycerin 0.5 % Ophthalmic SolutionSY1
2609932Regener-Eyes 0.5 % Ophthalmic SolutionSY1
2609932Regener-Eyes 5 MG/ML Ophthalmic SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87354-004-01Regener-Eyes Ophthalmic Solution PROFESSIONAL1 mL in 1 BOTTLESOLUTION/ DROPS11
87354-004-01Regener-Eyes Ophthalmic Solution PROFESSIONAL1 in 1 CARTONSOLUTION/ DROPS11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87354-00487354-004-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
ndc (package): 87354-004-01
ndc (product): 87354-004
ndc11 (package): 87354000401
spl id: 49771efa-6683-51d0-e063-6294a90a18a5
spl set id: 49771efa-6682-51d0-e063-6294a90a18a5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.