LUBRICANT EYE- 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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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

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

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 (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
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.