RxNorm Names

Review RxNorm Normal Forms

LUBRICANT EYE (mineral oil and petrolatum) ointment
[Akorn, Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b086dc94-ff35-43c6-a5a0-8a25d6104d61

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph final

NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Drug Facts

Active ingredient

Mineral Oil

12%

White Petrolatum

88%

Contains no preservatives or lanolin.

Purpose

Eye lubricant

Uses

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

Warnings

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.

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.

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

Directions

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

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

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

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

LUBRICANT EYE
mineral oil and petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17478-063
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Mineral Oil (Mineral Oil)	Mineral Oil	120 mg in 1 g
Petrolatum (Petrolatum)	Petrolatum	880 mg in 1 g

Packaging
#	Item Code	Package Description
1	NDC:17478-063-35	1 in 1 CARTON
1		3.5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	04/01/1993

Labeler - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(17478-063), ANALYSIS(17478-063), STERILIZE(17478-063), PACK(17478-063), LABEL(17478-063)

Revised: 10/2012

Document Id: 1b32e063-96e1-489b-9638-466ea56afc63

Set id: b086dc94-ff35-43c6-a5a0-8a25d6104d61

Version: 1

Effective Time: 20121004

Akorn, Inc.

Daily Med

Current Medication Information

Options

Additional Resources