LUBRICATING RELIEF- polyethylene glycol 400 and propylene glycol solution/ drops

lubricating relief by

Drug Labeling and Warnings

lubricating relief by is a Otc medication manufactured, distributed, or labeled by Kroger Company, 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 (1 -800-222-1222).

Directions

• Shake well before using.
• 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, 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?

1-800-632-6900

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

30142-327-04

Kroger Logo® STERILE

eye drops

lubricating relief

Polyethylene Glycol 400 0.4%/Propylene Glycol 0.3%

10 mL (0.3 FL OZ)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

COMPARE TO the active Ingredients of

SYSTANE ULTRA®*See side panel

30142-327-04

Kroger Logo®

FROM OUR FAMILY

TO YOURS

STERILE

eye drops

lubricating

relief

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

Lubricant eye drops

for irritated eyes

● Long-Lasting Protection

● Fast Relief

0.3 FL OZ (10 mL)

INGREDIENTS AND APPEARANCE

LUBRICATING RELIEF 
polyethylene glycol 400 and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-327
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: 30142-327-04	1 in 1 CARTON
1		10 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	02/22/2013

Labeler - Kroger Company (006999528)

Registrant - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(30142-327) , ANALYSIS(30142-327) , STERILIZE(30142-327) , PACK(30142-327) , LABEL(30142-327)