ARTIFICIAL TEARS- mineral oil and white petrolatum ointment

Artificial Tears by

Drug Labeling and Warnings

Artificial Tears by is a Animal medication manufactured, distributed, or labeled by Akorn Animal Health, Inc., Akorn, Inc, Croda Europe Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP)	Mineral Oil	150 mg  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	830 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Lanolin (UNII: 7EV65EAW6H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59399-162-35	1 in 1 CARTON
1		3.5 g in 1 TUBE

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. (078876357)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE, ANALYSIS, STERILIZE, PACK, LABEL

Establishment
Name	Address	ID/FEI	Business Operations
Croda Europe Ltd.		220690285	API MANUFACTURE