Regener-Eyes Ophthalmic Solution LITE XL

Manufacturer
M & M PRODUCTS, L.L.C.
Effective date
2026-01-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:35:48

Label at a glance#

ProductRegener-Eyes Ophthalmic Solution LITE XL
Active ingredientGLYCERIN
Label structure11 sections

Indications and uses

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. 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 ca...

Dosage and administration

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

Label contents#

Full prescribing information#

Carton Labeling - Drug Facts and other Panels (Non-PDP)

DESCRIPTION SECTION


Drug Facts
Active ingredient Glycerin 0.4%

Purpose: Eye Lubricant


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.


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


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


Inactive Ingredients
Sterile Water, Tonicity Solution Sodium Chloride.


Other information
Store at Room Temperature.


Questions?
(656) 225-2260


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.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Glycerin 0.4%

Purpose

OTC - PURPOSE SECTION

Purpose: Eye Lubricant

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

Indications and Uses

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 irritation 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.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Sterile Water, Tonicity Solution Sodium Chloride.

When Using

OTC - WHEN USING SECTION

Store at Room Temperature.

Patient Counseling

PATIENT COUNSELING INFORMATION

Questions?
(656) 225-2260

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.

Carton PDP - Front Panel - 5mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LITE XL LabelLITE XL LabelProprietary Name: Regener-Eyes Ophthalmic Solutiion LITE XL

Product Descriptor: Eye Lubricant

Key Claims: To Relieve Dryness of the Eye

Net Contents: 5mL

Regener-Eyes LITE XL Carton ArtworkRegener-Eyes LITE XL Carton Artwork

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2610311glycerin 0.4 % Ophthalmic SolutionPSN2
2610313Regener-Eyes Lite 0.4 % Ophthalmic SolutionPSN2
2610313glycerin 4 MG/ML Ophthalmic Solution [Regener-Eyes]SBD2
2610311glycerin 4 MG/ML Ophthalmic SolutionSCD2
2610311glycerin 0.4 % Ophthalmic SolutionSY2
2610313Regener-Eyes 4 MG/ML Ophthalmic SolutionSY2
2610313Regener-Eyes Lite 0.4 % Ophthalmic SolutionSY2

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
87354-001-01Regener-Eyes Ophthalmic Solution LITE XL1 in 1 CARTONSOLUTION/ DROPS12
87354-001-01Regener-Eyes Ophthalmic Solution LITE XL1 mL in 1 BOTTLESOLUTION/ DROPS12

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
87354-00187354-001-01

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
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
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
ndc (package): 87354-001-01
ndc (product): 87354-001
ndc11 (package): 87354000101
spl id: 49894c78-bc00-9116-e063-6294a90ac279
spl set id: 47ab9609-4291-30b2-e063-6394a90a421e

Reported adverse events (FAERS/openFDA)#

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