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

PEG-Phen Lubricant Eye Drops by

Drug Labeling and Warnings

PEG-Phen Lubricant Eye Drops by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen, 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

• Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

• Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inactive Ingredients:

Purified Water, Boric Acid, Hypromellose, Sodium Chloride, Potassium Chloride, Zinc Chloride, Calcium Chloride Diydrate, Magnesium Chloride Hexahydrate. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH;

Preservative: Benzalkonium Chloride.

QUESTIONS

Questions or comments?

1-800-579-8327

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

46122-199-05

Good Neighbor Pharmacy Logo ®

Lubricant

Eye Drops

PEG-Phen Lubricant Eye Drops

Long Lasting

Soothing comfort dry eye therapy

15 mL (0.5 fl oz)

Sterile

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

46122-199-05

Compare to Systane®

active ingredients*

Good Neighbor Pharmacy Logo ®

Lubricant

Eye Drops

PEG-Phen

Lubricant Eye Drops

Long Lasting

Soothing comfort

dry eye therapy

15 mL

(0.5 fl oz)

Sterile

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-199
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)
Boric Acid (UNII: R57ZHV85D4)
Hypromelloses (UNII: 3NXW29V3WO)
Sodium Chloride (UNII: 451W47IQ8X)
Potassium Chloride (UNII: 660YQ98I10)
Zinc Chloride (UNII: 86Q357L16B)
Calcium Chloride (UNII: M4I0D6VV5M)
Magnesium Chloride (UNII: 02F3473H9O)
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: 46122-199-05	1 in 1 CARTON
1		15 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	03/22/2013

Labeler - Amerisource Bergen (007914906)

Registrant - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(46122-199) , ANALYSIS(46122-199) , STERILIZE(46122-199) , PACK(46122-199) , LABEL(46122-199)