ARTIFICIAL TEARS- mineral oil and petrolatum ointment 

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.


Drug Facts

Active ingredient

Mineral Oil 15%

White Petrolatum 83%


Eye lubricant

Eye lubricant


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


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.


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

Inactive ingredient

Lanolin 2%

Principal Display Panel Text for Container Label:

NDC 17478-062-35 Akorn Logo

Artificial Tears OINTMENT

Lubricant Eye Ointment


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





Eye Ointment

Can Be Used at Bedtime


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

Principal Display Panel Text for Carton Label
mineral oil and petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17478-062
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP) Mineral Oil150 mg  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum830 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Lanolin (UNII: 7EV65EAW6H)  
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-062-351 in 1 CARTON09/01/1990
13.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/01/1990
Labeler - Akorn (117696770)
Registrant - Akorn Operating Company LLC (117693100)
NameAddressID/FEIBusiness Operations
Akorn117696840MANUFACTURE(17478-062) , ANALYSIS(17478-062) , STERILIZE(17478-062) , PACK(17478-062) , LABEL(17478-062)

Revised: 1/2022
Document Id: bc0d783a-a7df-47b6-91ec-30c45775afe5
Set id: c7479297-1ebc-4752-93b5-e4ad7f8c47f5
Version: 5
Effective Time: 20220121