Lubricant Eye

Manufacturer: Akorn | Akorn Operating Company LLC
Effective date: 2022-01-28
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:47:51

Label at a glance#

ProductLubricant Eye

Active ingredientMineral Oil, Petrolatum

Label structure9 sections

Indications and uses

For use as a lubricant for the temporary relief of burning and irritation due to dryness of the eyes.

Dosage and administration

Pull down lower lid of the affected eye(s) and apply small amount (one-fourth inch) of ointment to the inside of the eyelid, one or more times daily, or as directed by a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil

12%

White Petrolatum

88%

Contains no preservatives or lanolin.

Purpose

OTC - PURPOSE SECTION

Eye lubricant

Uses

INDICATIONS & USAGE SECTION

For use as a lubricant for the temporary relief of burning and irritation due to dryness of the eyes.

Warnings

WARNINGS SECTION

Do not use if bottom ridge of tube is exposed.
To avoid contamination, do not touch tip of container to any surface.
Replace cap after using.

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Pull down lower lid of the affected eye(s) and apply small amount (one-fourth inch) of ointment to the inside of the eyelid, one or more times daily, or as directed by a doctor.

Other information

SPL UNCLASSIFIED SECTION

Store at 20° to 25°C (68° to 77°F)
[see USP Controlled Room Temperature].
Store away from heat.
Protect from freezing.
Keep tightly closed.
See crimp for Control Number and Expiration Date.
RETAIN THIS CARTON FOR FUTURE REFERENCE.

NJTROAC Rev. 06/12

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-063-35 Akorn Logo

Lubricant Eye OINTMENT

Nighttime Relief For Dry Eyes Sterile

FOR OPHTHALMIC USE ONLY Net Wt. 3.5 g (1/8oz.)

Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-063-35

3.5 g

Lubricant

Eye

OINTMENT

Nighttime Relief

For Dry Eyes

Nighttime Relief

Plus Protection

Sterile

Net Wt. 3.5 g (1/8oz.)

Principal Display Panel Text for Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
701990	mineral oil 12 % / petrolatum 88 % Ophthalmic Ointment	PSN	4
701990	mineral oil 0.12 MG/MG / petrolatum 0.88 MG/MG Ophthalmic Ointment	SCD	4
701990	mineral oil 12 % / white petrolatum 88 % Ophthalmic Ointment	SY	4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-063-35	2024-01-30	C162847	48780-1	1030e364-ff58-111a-e063-dadaa90a10e2	b086dc94-ff35-43c6-a5a0-8a25d6104d61

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17478-063-35	Lubricant Eye	3.5 g in 1 TUBE	OINTMENT	3.5		4
17478-063-35	Lubricant Eye	1 in 1 CARTON	OINTMENT	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-063	LUBRICANT EYE (MINERAL OIL AND PETROLATUM) OINTMENT [AKORN]	4	Legacy NDC, 2 package rows	20220201_b086dc94-ff35-43c6-a5a0-8a25d6104d61.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Mineral Oil	ACTIVE INGREDIENT	T5L8T28FGP	1
Petrolatum	ACTIVE INGREDIENT	4T6H12BN9U	1
Mineral Oil	ACTIVE MOIETY	T5L8T28FGP	1
Petrolatum	ACTIVE MOIETY	4T6H12BN9U	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

Lubricant Eye
Mineral Oil and Petrolatum
Mineral Oil
Petrolatum

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17478-063	17478-063-35

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Mineral Oil	T5L8T28FGP	ACTIB
Petrolatum	4T6H12BN9U	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
b8c174b5-e2ab-4ed2-8c64-a5ec10252a93			b086dc94-ff35-43c6-a5a0-8a25d6104d61	2022-01-28	Warnings	Exact identifier spl id: b8c174b5-e2ab-4ed2-8c64-a5ec10252a93 spl set id: b086dc94-ff35-43c6-a5a0-8a25d6104d61

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.