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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

Purpose

Lubricant

Lubricant

Uses

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

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 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 Text for Container Label

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)

Principal Display Panel Text for Carton Label
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 DEA Schedule     
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)

Revised: 2/2013
Document Id: e0708482-5973-4090-9380-404c9249ca47
Set id: 843b4905-5be2-4858-813c-57f0e065c884
Version: 1
Effective Time: 20130221
 
Kroger Company