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Artificial Tears by Akorn, Inc.

Dosage form: ointment
Ingredients: Mineral Oil 150mg in 1g, Petrolatum 830mg in 1g
Labeler: Akorn, Inc.
NDC Code: 17478-062

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%

Purpose

Eye lubricant

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.

Inactive ingredient

Lanolin 2%

Principal Display Panel Text for Container Label:

NDC 17478-062-35 Akorn Logo

Artificial Tears OINTMENT

Lubricant Eye Ointment

Sterile

FOR OPHTHALMIC USE ONLY Net Wt. 3.5 g (1/8oz.)

Principal Display Panel Text for Carton Label:

NDC 17478-062-35

3.5 g

Artificial

Tears

OINTMENT

Lubricant

Eye Ointment

Can Be Used at Bedtime

Sterile

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

ARTIFICIAL TEARS 
mineral oil and petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17478-062
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Mineral Oil (Mineral Oil) Mineral Oil150 mg  in 1 g
Petrolatum (Petrolatum) Petrolatum830 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Lanolin 
Packaging
#Item CodePackage Description
1NDC:17478-062-351 TUBE in 1 CARTON
13.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/01/1990
Labeler - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIOperations
Akorn, Inc603980319MANUFACTURE(17478-062), ANALYSIS(17478-062), STERILIZE(17478-062), PACK(17478-062), LABEL(17478-062)

Revised: 01/2014
 
Akorn, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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