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NDC 17478-0063-35 Lubricant Eye 120; 880 mg/g; mg/g Details

Lubricant Eye 120; 880 mg/g; mg/g

Lubricant Eye is a OPHTHALMIC OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Akorn. The primary component is MINERAL OIL; PETROLATUM.

Product Information

NDC	17478-0063
Product ID	17478-063_b8c174b5-e2ab-4ed2-8c64-a5ec10252a93
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Lubricant Eye
Proprietary Name Suffix	n/a
Non-Proprietary Name	Mineral Oil and Petrolatum
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	OPHTHALMIC
Active Ingredient Strength	120; 880
Active Ingredient Units	mg/g; mg/g
Substance Name	MINERAL OIL; PETROLATUM
Labeler Name	Akorn
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2023-12-31

Package

Package Images

NDC 17478-0063-35 (17478006335)

Pricing Information	N/A
NDC Package Code	17478-063-35
Billing NDC	17478006335
Package	1 TUBE in 1 CARTON (17478-063-35) / 3.5 g in 1 TUBE
Marketing Start Date	1993-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b086dc94-ff35-43c6-a5a0-8a25d6104d61 Details

SPL UNCLASSIFIED SECTION

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

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

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

INGREDIENTS AND APPEARANCE

LUBRICANT EYE

mineral oil and petrolatum ointment

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP)	Mineral Oil	120 mg in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	880 mg in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17478-063-35	1 in 1 CARTON	04/01/1993
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - Akorn (117696770)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696840	MANUFACTURE(17478-063) , ANALYSIS(17478-063) , STERILIZE(17478-063) , PACK(17478-063) , LABEL(17478-063)

Revised: 1/2022

Document Id: b8c174b5-e2ab-4ed2-8c64-a5ec10252a93

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

Version: 4

Effective Time: 20220128

Search by Drug Name or NDC

NDC 17478-0063-35 Lubricant Eye 120; 880 mg/g; mg/g Details

Lubricant Eye 120; 880 mg/g; mg/g

Product Information

Package

Package Images

NDC 17478-0063-35 (17478006335)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b086dc94-ff35-43c6-a5a0-8a25d6104d61 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Directions

Other information

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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