SPL v1
SPL
SPL Set ID 497763ee-dc70-bb48-e063-6294a90afb3d
Route
OPHTHALMIC
Published
Effective Date 2026-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (4 mg)
Inactive Ingredients
Water Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-02-01

Description

Active Ingredient Glycerin 0.5%

Purpose

Purpose: Eye Lubricant

Dosage and Administration

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


Medication Information

Purpose

Purpose: Eye Lubricant

Dosage and Administration

Directions:

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

Description

Active Ingredient Glycerin 0.5%

Section 51945-4

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 asl 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

When Using

Store at Room Temperature.

Active Ingredient

Active Ingredient Glycerin 0.5%

Patient Counseling

Questions?

(656) 225-2260

Indications & 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 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.

Inactive Ingredients

Inactive Ingredients:

Sterile Water, Tonicity Solution Sodium Chloride.

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

Section 51945-4 (51945-4)

Purpose

Purpose: Eye Lubricant

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 asl 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

When Using

Store at Room Temperature.

Active Ingredient

Active Ingredient Glycerin 0.5%

Patient Counseling

Questions?

(656) 225-2260

Indications & 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 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.

Inactive Ingredients

Inactive Ingredients:

Sterile Water, Tonicity Solution Sodium Chloride.

Dosage and Administration

Directions:

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

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

All Sections (JSON)