LUBRICANT EYE- mineral oil and petrolatum ointment

Lubricant Eye by

Drug Labeling and Warnings

Lubricant Eye by is a Otc medication manufactured, distributed, or labeled by Akorn, Akorn Operating Company LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Mineral Oil

12%

White Petrolatum

88%

Contains no preservatives or lanolin.

Purpose

Eye lubricant

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.)

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 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)