SPL v2
SPL
SPL Set ID 47ab9609-4291-30b2-e063-6394a90a421e
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

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.

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

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.

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.

When Using

Store at Room Temperature.

Active Ingredient

Active ingredient Glycerin 0.4%

Patient Counseling

Questions?

(656) 225-2260

Inactive Ingredients

Inactive Ingredients

Sterile Water, Tonicity Solution Sodium Chloride.

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 can be used as a protectant against further irritation or to relieve dryness of the eye.

Keep Out of Reach of Children

Keep out of reach of children

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

Carton Pdp Front Panel 5ml

Proprietary Name: Regener-Eyes Ophthalmic Solutiion LITE XL

Product Descriptor: Eye Lubricant

Key Claims: To Relieve Dryness of the Eye

Net Contents: 5mL

Carton Labeling Drug Facts and Other Panels (non Pdp)



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.


Structured Label Content

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 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.

When Using

Store at Room Temperature.

Active Ingredient

Active ingredient Glycerin 0.4%

Patient Counseling

Questions?

(656) 225-2260

Inactive Ingredients

Inactive Ingredients

Sterile Water, Tonicity Solution Sodium Chloride.

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 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.

Keep Out of Reach of Children (Keep out of reach of Children)

Keep out of reach of children

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

Carton Pdp Front Panel 5ml (Carton PDP - Front Panel - 5mL)

Proprietary Name: Regener-Eyes Ophthalmic Solutiion LITE XL

Product Descriptor: Eye Lubricant

Key Claims: To Relieve Dryness of the Eye

Net Contents: 5mL

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



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.


Advanced Ingredient Data


Raw Label Data

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