Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 145b66e2-00e1-410e-8539-e12ffc4f6f82

Route

OPHTHALMIC

Published

Effective Date 2025-01-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Light Mineral Oil (2 mg) Mineral Oil

Inactive Ingredients

Cetalkonium Chloride Glycerin Poloxamer 188 Tromethamine Hydrochloride Tromethamine Tyloxapol Water

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-02-10

Description

Active Ingredients Purpose Light Mineral Oil (0.5%)............................Emollient Mineral Oil (0.5%)......................................Emollient

Medication Information

Description

Active Ingredients Purpose Light Mineral Oil (0.5%)............................Emollient Mineral Oil (0.5%)......................................Emollient

Uses

For use as a protectant against further irritation or to relieve dryness of the eye.

Section 55106-9

Active Ingredients Purpose

Light Mineral Oil (0.5%)............................Emollient

Mineral Oil (0.5%)......................................Emollient

Warnings

For use in the eyes only.

Directions

Shake well before using.
To open, completely twist off cap.
Instill 1 to 2 drops in the affected eye(s) as needed and discard container.

Do Not Use

If this product changes color.

Questions?

Call 888-965-8006 or visit www.eyeleve.com

Other Information

Use only if twist top of single-dose container is intact.
Drops appear as a milky white solution.
Store between 15°-30°C (59°- 86°F).

Inactive Ingredients

Cetalkonium Chloride, Glycerol, Poloxamer 188, Tris Hydrochloride, Tromethamine, Tyloxapol, Water for Injection

When Using This Product

Do not touch tip of container to any surface to avoid contamination.
Do not reuse once opened.

Stop Use and Ask A Doctor If

You feel eye pain or changes in vision, continued irritation or redness of the eye.
The 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.

Principal Display Panel 5 Sterile Single Dose Containers

NDC – 72347-010-05

INSTANT DRY EYE RELIEF

eyeleve _® MGD

by Bruder _®

NEW

Preservative-Free

Moisture-Rich Formula

Provides Soothing Comfort

Relieves Irritation

5 Sterile Single-Dose Containers

0.01 fl oz (0.4mL) ea.

PROFESSIONAL SAMPLE – NOT FOR RESALE

Principal Display Panel 30 Sterile Single Dose Containers

NDC 72347-010-30

LUBRICANT EYE DROPS

eyeleve _®

MGD

by Bruder _®

NEW

INSTANT DRY EYE RELIEF

Preservative-Free

Moisture-Rich Formula

Provides Soothing Comfort

Relieves Irritation

30 Sterile Single-Dose Containers 0.01 fl oz (0.4mL) ea.

Structured Label Content

Uses

For use as a protectant against further irritation or to relieve dryness of the eye.

Section 55106-9 (55106-9)

Active Ingredients Purpose

Light Mineral Oil (0.5%)............................Emollient

Mineral Oil (0.5%)......................................Emollient

Warnings

For use in the eyes only.

Directions

Shake well before using.
To open, completely twist off cap.
Instill 1 to 2 drops in the affected eye(s) as needed and discard container.

Do Not Use (Do not use)

If this product changes color.

Questions?

Call 888-965-8006 or visit www.eyeleve.com

Other Information (Other information)

Use only if twist top of single-dose container is intact.
Drops appear as a milky white solution.
Store between 15°-30°C (59°- 86°F).

Inactive Ingredients (Inactive ingredients)

Cetalkonium Chloride, Glycerol, Poloxamer 188, Tris Hydrochloride, Tromethamine, Tyloxapol, Water for Injection

When Using This Product (When using this product)

Do not touch tip of container to any surface to avoid contamination.
Do not reuse once opened.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

You feel eye pain or changes in vision, continued irritation or redness of the eye.
The condition worsens or persists for more than 72 hours.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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

Principal Display Panel 5 Sterile Single Dose Containers (PRINCIPAL DISPLAY PANEL - 5 Sterile Single-Dose Containers)

NDC – 72347-010-05

INSTANT DRY EYE RELIEF

eyeleve _® MGD

by Bruder _®

NEW

Preservative-Free

Moisture-Rich Formula

Provides Soothing Comfort

Relieves Irritation

5 Sterile Single-Dose Containers

0.01 fl oz (0.4mL) ea.

PROFESSIONAL SAMPLE – NOT FOR RESALE

Principal Display Panel 30 Sterile Single Dose Containers (PRINCIPAL DISPLAY PANEL - 30 Sterile Single-Dose Containers)

NDC 72347-010-30

LUBRICANT EYE DROPS

eyeleve _®

MGD

by Bruder _®

NEW

INSTANT DRY EYE RELIEF

Preservative-Free

Moisture-Rich Formula

Provides Soothing Comfort

Relieves Irritation

30 Sterile Single-Dose Containers 0.01 fl oz (0.4mL) ea.

Advanced Ingredient Data

[{"name": "CETALKONIUM CHLORIDE", "unii": "85474O1N9D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 188", "unii": "LQA7B6G8JG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROMETHAMINE HYDROCHLORIDE", "unii": "383V75M34E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROMETHAMINE", "unii": "023C2WHX2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TYLOXAPOL", "unii": "Y27PUL9H56", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "0.4", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "0.4", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For use as a protectant against further irritation or to relieve dryness of the eye.", "55106-9": "Active Ingredients Purpose Light Mineral Oil (0.5%)............................Emollient Mineral Oil (0.5%)......................................Emollient", "Warnings": "For use in the eyes only.", "Directions": "Shake well before using. To open, completely twist off cap. Instill 1 to 2 drops in the affected eye(s) as needed and discard container.", "Do not use": "If this product changes color.", "Questions?": "Call 888-965-8006 or visit www.eyeleve.com", "Other information": "Use only if twist top of single-dose container is intact. Drops appear as a milky white solution. Store between 15°-30°C (59°- 86°F).", "Inactive ingredients": "Cetalkonium Chloride, Glycerol, Poloxamer 188, Tris Hydrochloride, Tromethamine, Tyloxapol, Water for Injection", "When using this product": "Do not touch tip of container to any surface to avoid contamination. Do not reuse once opened.", "Stop use and ask a doctor if": "You feel eye pain or changes in vision, continued irritation or redness of the eye. The 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.", "PRINCIPAL DISPLAY PANEL - 5 Sterile Single-Dose Containers": "NDC – 72347-010-05 INSTANT DRY EYE RELIEF eyeleve ® MGD by Bruder ® NEW Preservative-Free Moisture-Rich Formula Provides Soothing Comfort Relieves Irritation 5 Sterile Single-Dose Containers 0.01 fl oz (0.4mL) ea. PROFESSIONAL SAMPLE – NOT FOR RESALE", "PRINCIPAL DISPLAY PANEL - 30 Sterile Single-Dose Containers": "NDC 72347-010-30 LUBRICANT EYE DROPS eyeleve ® MGD by Bruder ® NEW INSTANT DRY EYE RELIEF Preservative-Free Moisture-Rich Formula Provides Soothing Comfort Relieves Irritation 30 Sterile Single-Dose Containers 0.01 fl oz (0.4mL) ea."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:31.635935 · Updated: 2026-03-14T23:09:19.585027