Major Lubrifresh P.m.

SPL v13

SPL

SPL Set ID bd85d4b6-7093-4e89-ae7b-2a293a0775f2

Route

OPHTHALMIC

Published

Effective Date 2025-09-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Mineral Oil (150 mg) Petrolatum (830 mg)

Inactive Ingredients

Lanolin Alcohols

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2015-09-11 Until 2026-10-31

Description

Active ingredients Purpose Mineral oil 15%...................................................Lubricant White petrolatum 83%.........................................Lubricant

Medication Information

Warnings and Precautions

Warnings

•
For external use only.
•
To avoid contamination, do not touch tip of container to any surface
•
Keep tube tightly closed

Indications and Usage

Directions

•
Wash your hands.
•
Pull down the lower lid of the affected eye(s) and gently apply a small amount (1/4") of ointment to the inside of the eyelid, every 3-4 hours or as directed by a doctor.

Dosage and Administration

Distributed by:

Major Pharmaceuticals

17177 N Laurel Park Dr.,

Suiet 233

Livonia, MI 48150

Rev. 03/24

M-155

Re-order No. 701039

Description

Active ingredients Purpose Mineral oil 15%...................................................Lubricant White petrolatum 83%.........................................Lubricant

Section 44425-7

Other information

•
Store away from heat
•
Protect from freezing
•
Use before expiration date marked on container
•
Store at 59°-86°F (15°-30°C)

Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50569-3

Stop use and ask a doctor if

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

Section 51727-6

Inactive ingredients

Lanolin alcohol

Section 55105-1

Uses

•
For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
•
May be used as a protectant against further irritation

Section 55106-9

Active ingredients Purpose

Mineral oil 15%...................................................Lubricant

White petrolatum 83%.........................................Lubricant

If Pregnant Or Breast Feeding

•
If pregnant or breast feeding, ask a health professional before use.

Principal Display Panel Tube

MAJOR®

NDC 0904-6488-38

LubriFresh™ P.M.

Nighttime Ointment

Principal Display Panel Carton

MAJOR®

NDC 0904-6488-38

LubiFresh™ P.M.

Nighttime Ointment

Lubricant Eye

Ointment

Relieves irritation and

dryness of the eye

Preservative Free

Sterile

NET WT 0.125 OZ (3.5 g)

Structured Label Content

Indications and Usage (34067-9)

Directions

•
Wash your hands.
•
Pull down the lower lid of the affected eye(s) and gently apply a small amount (1/4") of ointment to the inside of the eyelid, every 3-4 hours or as directed by a doctor.

Dosage and Administration (34068-7)

Distributed by:

Major Pharmaceuticals

17177 N Laurel Park Dr.,

Suiet 233

Livonia, MI 48150

Rev. 03/24

M-155

Re-order No. 701039

Warnings and Precautions (34071-1)

Warnings

•
For external use only.
•
To avoid contamination, do not touch tip of container to any surface
•
Keep tube tightly closed

Section 44425-7 (44425-7)

Other information

•
Store away from heat
•
Protect from freezing
•
Use before expiration date marked on container
•
Store at 59°-86°F (15°-30°C)

Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50569-3 (50569-3)

Stop use and ask a doctor if

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

Section 51727-6 (51727-6)

Inactive ingredients

Lanolin alcohol

Section 55105-1 (55105-1)

Uses

•
For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
•
May be used as a protectant against further irritation

Section 55106-9 (55106-9)

Active ingredients Purpose

Mineral oil 15%...................................................Lubricant

White petrolatum 83%.........................................Lubricant

If Pregnant Or Breast Feeding (If pregnant or breast feeding)

•
If pregnant or breast feeding, ask a health professional before use.

Principal Display Panel Tube (Principal Display Panel - tube)

MAJOR®

NDC 0904-6488-38

LubriFresh™ P.M.

Nighttime Ointment

Principal Display Panel Carton (Principal Display Panel - carton)

MAJOR®

NDC 0904-6488-38

LubiFresh™ P.M.

Nighttime Ointment

Lubricant Eye

Ointment

Relieves irritation and

dryness of the eye

Preservative Free

Sterile

NET WT 0.125 OZ (3.5 g)

Advanced Ingredient Data

[{"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "ACTIB", "strengthNumerator": "150", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "830", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "LANOLIN ALCOHOLS", "unii": "884C3FA9HE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Directions • Wash your hands. • Pull down the lower lid of the affected eye(s) and gently apply a small amount (1/4") of ointment to the inside of the eyelid, every 3-4 hours or as directed by a doctor.", "34068-7": "Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suiet 233 Livonia, MI 48150 Rev. 03/24 M-155 Re-order No. 701039", "34071-1": "Warnings • For external use only. • To avoid contamination, do not touch tip of container to any surface • Keep tube tightly closed", "44425-7": "Other information • Store away from heat • Protect from freezing • Use before expiration date marked on container • Store at 59°-86°F (15°-30°C)", "50565-1": "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "50569-3": "Stop use and ask a doctor if • You experience eye pain, changes in vision, continued redness or irritation of the eye • The condition worsens or persists more than 72 hours", "51727-6": "Inactive ingredients Lanolin alcohol", "55105-1": "Uses • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun • May be used as a protectant against further irritation", "55106-9": "Active ingredients Purpose Mineral oil 15%...................................................Lubricant White petrolatum 83%.........................................Lubricant", "If pregnant or breast feeding": "• If pregnant or breast feeding, ask a health professional before use.", "Principal Display Panel - tube": "MAJOR® NDC 0904-6488-38 LubriFresh™ P.M. Nighttime Ointment", "Principal Display Panel - carton": "MAJOR® NDC 0904-6488-38 LubiFresh™ P.M. Nighttime Ointment Lubricant Eye Ointment Relieves irritation and dryness of the eye Preservative Free Sterile NET WT 0.125 OZ (3.5 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:56.437135 · Updated: 2026-03-14T23:10:01.237919