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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:17478-063
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Mineral Oil (Mineral Oil) Mineral Oil120 mg  in 1 g
Petrolatum (Petrolatum) Petrolatum880 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-063-351 in 1 CARTON
13.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34904/01/1993
Labeler - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc603980319MANUFACTURE(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.