Artificial Tears: Product Information

ARTIFICIAL TEARS- mineral oil and petrolatum ointment
Akorn Animal Health, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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 eye(s).

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 condition persists or increases discontinue use and consult veterinarian.

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 59399-162-35 Akorn Animal Health Logo

3.5 g

ARTIFICIAL TEARS

Lubricant Ophthalmic Ointment FOR OPHTHALMIC USE ONLY

For Veterinary Use Net Wt 3.5g (1/8 oz) Sterile

Principal Display Panel Text for Container Label
(click image for full-size original)

Principal Display Panel Text for Carton Label:

NDC 59399-162-35

Akorn Animal Health Logo

3.5 g

ARTIFICIAL

TEARS

Lubricant Ophthalmic

Ointment

For

Veterinary

Use

Sterile

Net Wt 3.5g (1/8 oz)

Principal Display Panel Text for Carton Label
(click image for full-size original)
ARTIFICIAL TEARS
mineral oil and white petrolatum ointment
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:59399-162
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mineral Oil (Mineral Oil) Mineral Oil 150 mg in 1 g
Petrolatum (Petrolatum) Petrolatum 830 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Lanolin
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59399-162-35 1 TUBE in 1 CARTON contains a TUBE
1 3.5 g in 1 TUBE This package is contained within the CARTON (59399-162-35)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/15/2015
Labeler — Akorn Animal Health, Inc. (117696748)
Registrant — Akorn Operating Company LLC (117693100)
Establishment
Name Address ID/FEI Operations
Akorn, Inc 117696840 MANUFACTURE, ANALYSIS, STERILIZE, PACK, LABEL
Establishment
Name Address ID/FEI Operations
Croda Europe Ltd. 220690285 API MANUFACTURE

Revised: 10/2020 Akorn Animal Health, Inc.

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