FDA.reportPublic FDA data

Regener-Eyes

Manufacturer
Regenerative Processing Plant, LLC | Regenerative Process Plant
Effective date
2022-08-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:55:09

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 4 drops, one to four times per day in each eye, or as recommended by your eye care professional.

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 4 drops, one to four times per day in each eye, or as recommended by your eye care professional.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Tonicity Solution TM; Sterile Water.

Other information

OTC - WHEN USING SECTION

  • Store at Room Temperature.

Questions?

PATIENT COUNSELING INFORMATION

Questions? (800) 781-0818

Artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Regener-Eyes Ophthalmic Solution LITE Box LabelRegener-Eyes Ophthalmic Solution LITE Box LabelRegener-Eyes Ophthalmic Solution LITE Primary LabelRegener-Eyes Ophthalmic Solution LITE Primary Label

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
82305-00482305-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
WATER059QF0KO0RIACT

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
e7773258-9e14-140f-e053-2995a90a232ae6993ab7-d042-6d71-e053-2995a90a6a142022-08-30WarningsExact identifier
spl set id: e6993ab7-d042-6d71-e053-2995a90a6a14

Reported adverse events (FAERS/openFDA)#

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