ULTRA LUBRICANT EYE DROPS- polyethylene glycol 400 and propylene glycol solution/ drops

Ultra Lubricant Eye Drops by

Drug Labeling and Warnings

Ultra Lubricant Eye Drops by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, Akorn, Inc., Akorn, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

Purpose

Lubricant

Lubricant

Uses

For the temporary relief of burning and irritation due to dryness of the eye.

Warnings

For external use only.

Do not use

• if this product changes color or becomes cloudy
• if you are sensitive to any ingredient in this product

When using this product

• do not touch tip of container to any surface to avoid contamination
• replace cap after each use

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• shake well before using
• instill 1 or 2 drops in the affected eye(s) as needed.

Other information

• store at 20° to 25°C (68°to77°F) [see USP Controlled Room Temperature].

Inactive ingredients

Purified Water, Sorbitol solution, Boric Acid, 2-amino-2-methyl-1-propanol, Hypromellose USP, Sodium Chloride, Potassium Chloride. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH;

Preservative

Benzalkonium Chloride.

Questions or comments?

1-800-932-5676

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC: 68016-402-00

Premier

Value® Logo

Ultra Lubricant

Eye Drops

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

10 mL (0.34 FL OZ) STERILE

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC: 68016-402-00

*COMPARE TO THE

ACTIVE INGREDIENT

IN SYSTANE® ULTRA

Premier

Value® Logo

Ultra

Lubricant

Eye Drops

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

• Lubricant eye drops for irritated eyes
• Long lasting protection
• Fast relief

10 mL (0.34 FL OZ)

STERILE PV Brand Logo

INGREDIENTS AND APPEARANCE

ULTRA LUBRICANT EYE DROPS 
polyethylene glycol 400 and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-402
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ)	Polyethylene Glycol 400	4 mg  in 1 mL
Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3)	Propylene Glycol	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
Boric Acid (UNII: R57ZHV85D4)
Aminomethylpropanol (UNII: LU49E6626Q)
Hypromelloses (UNII: 3NXW29V3WO)
Sodium Chloride (UNII: 451W47IQ8X)
Potassium Chloride (UNII: 660YQ98I10)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)
Benzalkonium Chloride (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-402-00	1 in 1 CARTON
1		10 mL in 1 BOTTLE, DROPPER; 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	01/10/2014

Labeler - Chain Drug Consortium (101668460)

Registrant - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(68016-402) , ANALYSIS(68016-402) , STERILIZE(68016-402) , PACK(68016-402) , LABEL(68016-402)