ARTIFICIAL TEAR- lanolin, mineral oil and petrolatum ointment
Akorn, Inc.

Disclaimer: 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.

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Artificial Tear

Drug Facts

Active ingredient

Lanolin 2%

Mineral Oil 15%

White Petrolatum 83%

Purpose

Eye lubricant

Uses

For use as a lubricant to prevent further irritation or to relieve dryness of the eyes.

Warnings

For external use only.
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.

Principal Display Panel Text for Container Label:

NDC 17478-062-35 Akorn Logo

Artificial Tear OINTMENT

Lubricant Eye Ointment

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 17478-062-35

3.5 g

Artificial

Tear

OINTMENT

Lubricant

Eye Ointment

Can Be Used at Bedtime

Sterile

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

Principal Display Panel Text for Carton Label

ARTIFICIAL TEAR
lanolin, mineral oil, petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:17478-062
Route of Administration	OPHTHALMIC	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Lanolin (Lanolin)	Lanolin	20 mg in 1 g
Mineral Oil (Mineral Oil)	Mineral Oil	150 mg in 1 g
Petrolatum (Petrolatum)	Petrolatum	830 mg in 1 g

#	Item Code	Package Description
Packaging
1	NDC:17478-062-35	1 in 1 CARTON
1		3.5 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	09/01/1990

Labeler - Akorn, Inc. (062649876)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn, Inc		603980319	MANUFACTURE(17478-062), ANALYSIS(17478-062), STERILIZE(17478-062), PACK(17478-062), LABEL(17478-062)

Revised: 3/2012

Document Id: 0e08b38e-710f-4126-bacf-5a13838493b5

Set id: c7479297-1ebc-4752-93b5-e4ad7f8c47f5

Version: 1

Effective Time: 20120320

Akorn, Inc.