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Artificial Tears by MWI

Medically reviewed on March 23, 2018

Dosage form: ointment
Ingredients: Mineral Oil 150mg in 1g, Petrolatum 830mg in 1g
Labeler: MWI
NDC Code: 13985-600

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 ingredients

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 13985-600-03

Apexa logo

Artificial Tears STERILE

Ophthalmic Lubricant Ointment

Prevents Irritation and Relieves Dryness of the eye

Can be used at bedtime

AP 704001 Net Weight: 3.5g (1/8 oz)

Principal Display Panel Text for Carton Label:

NDC 13985-600-03

Artificial Tears

Ophthalmic

Lubricant

Ointment

STERILE

Prevents Irritation

and Relieves

Dryness of the eye

Can be used

at bedtime

Apexa logo

AP 704001

Net Weight: 3.5g (1/8 oz)

ARTIFICIAL TEARS 
mineral oil and petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13985-600
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:13985-600-031 TUBE in 1 CARTON
13.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/23/2015
Labeler - MWI (019926120)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIOperations
Akorn, Inc603980319MANUFACTURE(13985-600), ANALYSIS(13985-600), STERILIZE(13985-600), PACK(13985-600), LABEL(13985-600)

 
MWI

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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