EYELEVE MGD- mineral oil emulsion

Eyeleve MGD by

Drug Labeling and Warnings

Eyeleve MGD by is a Otc medication manufactured, distributed, or labeled by Bruder Healthcare, Excelvision. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

Warnings

For use in the eyes only.

Do not use

• If this product changes color.

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.

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.

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

Questions?

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

PURPOSE

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.

INGREDIENTS AND APPEARANCE

EYELEVE MGD 
mineral oil emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72347-010
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP) (LIGHT MINERAL OIL - UNII:N6K5787QVP)	LIGHT MINERAL OIL	2 mg  in 0.4 mL
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	2 mg  in 0.4 mL

Inactive Ingredients
Ingredient Name	Strength
CETALKONIUM CHLORIDE (UNII: 85474O1N9D)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 188 (UNII: LQA7B6G8JG)
TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E)
TROMETHAMINE (UNII: 023C2WHX2V)
TYLOXAPOL (UNII: Y27PUL9H56)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (Milky White)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72347-010-30	30 in 1 BOX	02/10/2025
1		0.4 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2	NDC: 72347-010-05	5 in 1 BOX	02/10/2025
2		0.4 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	02/10/2025

Labeler - Bruder Healthcare (118449190)

Registrant - Bruder Healthcare (118449190)

Establishment
Name	Address	ID/FEI	Business Operations
Excelvision		274234566	analysis(72347-010) , label(72347-010) , manufacture(72347-010) , pack(72347-010)