FDA.reportPublic FDA data

Regener-Eyes

Manufacturer
Regenerative Processing Plant, LLC | Regenerative Processing Plant
Effective date
2025-03-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:57:31

Label at a glance#

ProductRegener-Eyes PRO
Active ingredientGLYCERIN
Label structure10 sections

Indications and 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.

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Glycerin, 0.5%

Purpose

OTC - PURPOSE SECTION

Eye Lubricant

Uses

INDICATIONS & USAGE SECTION

  • 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.

Warnings

WARNINGS SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

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

RECENT MAJOR CHANGES SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sterile Water, Tonicity Solution Sodium Chloride

Other information

OTC - WHEN USING SECTION

  • Store at refrigerated conditions once the bottle closure is activated to the open position.

Questions?

PATIENT COUNSELING INFORMATION

Questions? (800) 781-0818

Artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Professional Strength LabelProfessional Strength Label

Professional Strength V4 Carton.jpgProfessional Strength V4 Carton.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2540675glycerin 0.5 % Ophthalmic SolutionPSN8
2609932Regener-Eyes 0.5 % Ophthalmic SolutionPSN8
2609932glycerin 5 MG/ML Ophthalmic Solution [Regener-Eyes]SBD8
2540675glycerin 5 MG/ML Ophthalmic SolutionSCD8
2540675glycerin 0.5 % Ophthalmic SolutionSY8
2609932Regener-Eyes 0.5 % Ophthalmic SolutionSY8
2609932Regener-Eyes 5 MG/ML Ophthalmic SolutionSY8

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
82305-003-01Regener-EyesPRO3 in 1 BOXSOLUTION/ DROPS38
82305-003-01Regener-EyesPRO3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS38
82305-003-02Regener-EyesPRO1 in 1 BOXSOLUTION/ DROPS18
82305-003-02Regener-EyesPRO3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS38

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82305-003REGENER-EYES PRO (REGENER-EYES) SOLUTION/ DROPS [REGENERATIVE PROCESSING PLANT, LLC]8Legacy NDC, 4 package rows20250322_e689001a-3640-1d45-e053-2995a90a4032.zip

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
82305-00382305-003-01, 82305-003-02

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
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
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
30cb2afc-827d-5e43-e063-6294a90a50e3e689001a-3640-1d45-e053-2995a90a40322025-03-20WarningsExact identifier
spl id: 30cb2afc-827d-5e43-e063-6294a90a50e3
spl set id: e689001a-3640-1d45-e053-2995a90a4032

Reported adverse events (FAERS/openFDA)#

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