ARTIFICIAL TEARS- mineral oil and petrolatum ointment

Artificial Tears by

Drug Labeling and Warnings

Artificial Tears by is a Otc medication manufactured, distributed, or labeled by MWI, Akorn, Inc., Akorn, Inc. 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 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

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

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)

INGREDIENTS AND APPEARANCE

ARTIFICIAL TEARS 
mineral oil and petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13985-600
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: 13985-600-03	1 in 1 CARTON	03/23/2015
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	03/23/2015

Labeler - MWI (019926120)

Registrant - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(13985-600) , ANALYSIS(13985-600) , STERILIZE(13985-600) , PACK(13985-600) , LABEL(13985-600)