Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 06f57d46-96c7-4093-84aa-874ff4b2131d
Route
OPHTHALMIC
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Light Mineral Oil (2 mg) Mineral Oil
Inactive Ingredients
Cetrimonium Bromide Glycerin Poloxamer 188 Tromethamine Hydrochloride Tromethamine Tyloxapol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-01-05

Description

Light Mineral Oil (0.5%) Mineral Oil (0.5%)

Purpose

Emollient


Medication Information

Purpose

Emollient

Description

Light Mineral Oil (0.5%) Mineral Oil (0.5%)

Uses

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

Warnings

For use in the eyes only.

Directions
  • Shake well before using.
  • Instill 1 or 2 drops in the affected eye(s) as needed and discard container.
Do Not Use
  • if this product changes color.
Questions?

Call (800) 233-5469 M-F 8:30AM-5:30PM CST

or visit www.ocusoft.com

Other Information
  • Use only if tamper seals on top and bottom flaps are intact.
  • Drops appear as a milky white emulsion.
  • Store between 15 o-30 oC (59 o-86 oF).
Active Ingredients

Light Mineral Oil (0.5%)

Mineral Oil (0.5%)

Inactive Ingredients

Cetrimonium Bromide, glycerin, 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 redness or irritation of the eye.
  • the condition worsens or persists for more than 72 hours.
Keep Out of the Reach of Children

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

Principal Display Panel 30 Sterile Single Dose Containers

NDC 54799-917-30



OCuSOFT ®



MGD™

ADVANCED™




Lubricant Eye Drops



Non-Preserved*

Relieves Irritation

Long-Lasting Comfort



Superior Dry Eye Relief

Without A Prescription




30 Sterile

Single-Dose Vials

0.01 fl oz (0.4 mL) each




Retaine® MGD™ Advanced™ is

a non-preserved* ophthalmic

emulsion that delivers complete

Dry Eye relief utilizing a

proprietary oil in water emulsion

technology (microemulsification)

with electrostatic attraction to

restore the three layers of the

tear film without blurring.



Replenishes LIPID LAYER and

reduces tear evaporation



Adds moisture to AQUEOUS

LAYER




Lubricates and protects

MUCIN LAYER



*Cetrimonium bromide is a cationic

stabilizer and is not added as a

preservative.



Positively Charged

Retaine® MGD™

Droplets



Negatively Charged

Ocular Surface



Use only if twist top of

single-dose vial is intact.




OCuSOFT®

Manufactured for OCuSOFT LLC.

Rosenberg, TX 77471 USA

© 2025 OCuSOFT Inc.

www.ocusoft.com

Patents: www.ocusoft.com/patents



All registered trademarks are property of

OCuSOFT Inc.


Structured Label Content

Uses

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

Purpose

Emollient

Warnings

For use in the eyes only.

Directions
  • Shake well before using.
  • Instill 1 or 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 (800) 233-5469 M-F 8:30AM-5:30PM CST

or visit www.ocusoft.com

Other Information (Other information)
  • Use only if tamper seals on top and bottom flaps are intact.
  • Drops appear as a milky white emulsion.
  • Store between 15 o-30 oC (59 o-86 oF).
Active Ingredients (Active ingredients)

Light Mineral Oil (0.5%)

Mineral Oil (0.5%)

Inactive Ingredients (Inactive ingredients)

Cetrimonium Bromide, glycerin, 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 redness or irritation of the eye.
  • the condition worsens or persists for more than 72 hours.
Keep Out of the Reach of Children (KEEP OUT OF THE REACH OF CHILDREN)

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

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

NDC 54799-917-30



OCuSOFT ®



MGD™

ADVANCED™




Lubricant Eye Drops



Non-Preserved*

Relieves Irritation

Long-Lasting Comfort



Superior Dry Eye Relief

Without A Prescription




30 Sterile

Single-Dose Vials

0.01 fl oz (0.4 mL) each




Retaine® MGD™ Advanced™ is

a non-preserved* ophthalmic

emulsion that delivers complete

Dry Eye relief utilizing a

proprietary oil in water emulsion

technology (microemulsification)

with electrostatic attraction to

restore the three layers of the

tear film without blurring.



Replenishes LIPID LAYER and

reduces tear evaporation



Adds moisture to AQUEOUS

LAYER




Lubricates and protects

MUCIN LAYER



*Cetrimonium bromide is a cationic

stabilizer and is not added as a

preservative.



Positively Charged

Retaine® MGD™

Droplets



Negatively Charged

Ocular Surface



Use only if twist top of

single-dose vial is intact.




OCuSOFT®

Manufactured for OCuSOFT LLC.

Rosenberg, TX 77471 USA

© 2025 OCuSOFT Inc.

www.ocusoft.com

Patents: www.ocusoft.com/patents



All registered trademarks are property of

OCuSOFT Inc.


Advanced Ingredient Data


Raw Label Data

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