FDA.reportPublic FDA data

Regener-Eyes

Manufacturer
Regenerative Processing Plant, LLC
Effective date
2025-03-20
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:57:31

Label at a glance#

ProductRegener-Eyes LITE
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

Directions Instill 1 to 2 drops, one to four times per day in each eye, or as recommended by your eye care professional. Instill 1 or 2 drops in the affected eye(s) as needed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Glycerin 0.4%

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

Warnings External Use Only

  • To avoid contamination, do not touch tip of the bottle closure to any surface(s) including the eye or the skin.
  • Do not use if solution changes color or becomes cloudy.

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

Directions Instill 1 to 2 drops, one to four times per day in each eye, or as recommended by your eye care professional.

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 Room Temperature.

Questions?

PATIENT COUNSELING INFORMATION

Questions? (800) 781-0818

Artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LITE LabelLITE Label

LITE V4 Carton.jpgLITE V4 Carton.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2610311glycerin 0.4 % Ophthalmic SolutionPSN9
2610313Regener-Eyes Lite 0.4 % Ophthalmic SolutionPSN9
2610313glycerin 4 MG/ML Ophthalmic Solution [Regener-Eyes]SBD9
2610311glycerin 4 MG/ML Ophthalmic SolutionSCD9
2610311glycerin 0.4 % Ophthalmic SolutionSY9
2610313Regener-Eyes 4 MG/ML Ophthalmic SolutionSY9
2610313Regener-Eyes Lite 0.4 % Ophthalmic SolutionSY9

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
82305-006-01Regener-EyesLITE3 in 1 BOXSOLUTION/ DROPS39
82305-006-01Regener-EyesLITE3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS39
82305-006-02Regener-EyesLITE3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS39
82305-006-02Regener-EyesLITE1 in 1 BOXSOLUTION/ DROPS19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82305-006REGENER-EYES LITE (GLYCERIN) SOLUTION/ DROPS [REGENERATIVE PROCESSING PLANT, LLC]9Legacy NDC, 4 package rows20250322_e7796d0d-13d7-73c3-e053-2995a90a8bde.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82305-00682305-006-01, 82305-006-02

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
GLYCERINPDC6A3C0OXACTIB
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT

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
30caa73a-ed9b-753f-e063-6394a90add63e7796d0d-13d7-73c3-e053-2995a90a8bde2025-03-20WarningsExact identifier
spl id: 30caa73a-ed9b-753f-e063-6394a90add63
spl set id: e7796d0d-13d7-73c3-e053-2995a90a8bde

Reported adverse events (FAERS/openFDA)#

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