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

lubricant eye by

Drug Labeling and Warnings

lubricant eye by is a Otc medication manufactured, distributed, or labeled by Rite Aid, 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° to 77°F) [Room Temperature].

Inactive ingredients

2-amino-2-methyl-1-propanol, Benzalkonium Chloride, Boric Acid, Hydrochloric Acid*, Hypromellose USP, Potassium Chloride, Purified Water, Sodium Chloride, Sodium Hydroxide*, Sorbitol solution.

*May contain one or more of these ingredients to adjust pH.

Questions or comments?

1-800-932-5676

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC: 11822-2701-1

Rite Aid Logo

lubricant

eye drops

dry eye relief

STERILE 10 mL (0.34 FL OZ)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

TWIN PACK

Rite Aid Logo

*Compare to the active ingredients in

Systane Ultra® Lubricant Eye Drops

NDC: 11822-2701-1

lubricant

eye drops

dry eye relief

HIGH PERFORMANCE

extended protection

fast symptom relief

2

1- 10 mL

STERILE (0.34 FL OZ) BOTTLES

INGREDIENTS AND APPEARANCE

LUBRICANT EYE 
polyethylene glycol 400 and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-2701
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
Aminomethylpropanol (UNII: LU49E6626Q)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Boric Acid (UNII: R57ZHV85D4)
Hydrochloric Acid (UNII: QTT17582CB)
Hypromelloses (UNII: 3NXW29V3WO)
Potassium Chloride (UNII: 660YQ98I10)
Water (UNII: 059QF0KO0R)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Hydroxide (UNII: 55X04QC32I)
Sorbitol (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-2701-1	2 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	04/24/2015

Labeler - Rite Aid (014578892)

Registrant - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc.		603980319	MANUFACTURE(11822-2701) , ANALYSIS(11822-2701) , STERILIZE(11822-2701) , PACK(11822-2701) , LABEL(11822-2701)