48d6dc98-66e8-b499-e063-6394a90ae935

SPL v2
SPL
SPL Set ID 48d6dc98-66e8-b499-e063-6394a90ae935
Route
ophthalmic
Published
Effective Date 2026-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
glycerin (5 mg)
Inactive Ingredients
sodium chloride water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2026-02-01

Indications and Usage

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

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

Purpose

Purpose: Eye Lubricant

Description

Active ingredient Glycerin 0.5%


Medication Information

Warnings

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 Usage

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.

Purpose

Purpose: Eye Lubricant

Dosage and Administration

Directions

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

Inactive Ingredients

Inactive Ingredients

Sterile Water, Tonicity Solution Sodium Chloride.

Description

Active ingredient Glycerin 0.5%

Section 51945-4

Proprietary Name: Regener-Eyes Ophthalmic Solutiion LITE XL

Product Descriptor: Eye Lubricant

Key Claims: To Relieve Dryness of the Eye

Net Contents: 5mL

When Using

Store at Room Temperature.

Active Ingredient

Active ingredient Glycerin 0.5%

Patient Counseling

Questions?

(656) 225-2260

Keep Out of Reach of Children

Keep out of reach of children

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


Structured Label Content

Warnings

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 Usage

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.

Purpose

Purpose: Eye Lubricant

Dosage and Administration

Directions

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

Inactive Ingredients

Inactive Ingredients

Sterile Water, Tonicity Solution Sodium Chloride.

Section 51945-4 (51945-4)

Proprietary Name: Regener-Eyes Ophthalmic Solutiion LITE XL

Product Descriptor: Eye Lubricant

Key Claims: To Relieve Dryness of the Eye

Net Contents: 5mL

When Using

Store at Room Temperature.

Active Ingredient

Active ingredient Glycerin 0.5%

Patient Counseling

Questions?

(656) 225-2260

Keep Out of Reach of Children

Keep out of reach of children

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


Advanced Ingredient Data


Raw Label Data

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