FDA.reportPublic FDA data

Regener-Eyes

Manufacturer
Regenerative Processing Plant, LLC
Effective date
2026-01-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:53:22

Label at a glance#

ProductRegener-Eyes Professional Strength XL
Active ingredientGLYCERIN
Label structure10 sections

Indications and uses

For the temporary reflief 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.

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 reflief 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.

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

(800) 781-0818

Artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Professional Strength XL Carton

PROXLPROXL

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
82305-10382305-103-03

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
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-06-18monthly-update2026-06-03 17:45:10

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
4988c97a-af3b-16a8-e063-6294a90a899337db3492-abf3-7eed-e063-6394a90a833a2026-01-29WarningsExact identifier
spl id: 4988c97a-af3b-16a8-e063-6294a90a8993
spl set id: 37db3492-abf3-7eed-e063-6394a90a833a

Reported adverse events (FAERS/openFDA)#

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