Your browser does not support JavaScript! LUBRICATING RELIEF (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [KROGER COMPANY]
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RxNorm Names

LUBRICATING RELIEF (polyethylene glycol 400 and propylene glycol) solution/ drops
[Kroger Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:30142-327
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 4004 mg  in 1 mL
Propylene Glycol (Propylene Glycol) Propylene Glycol3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Sorbitol 
Boric Acid 
Aminomethylpropanol 
Hypromelloses 
Sodium Chloride 
Potassium Chloride 
Hydrochloric Acid 
Sodium Hydroxide 
Benzalkonium Chloride 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-327-041 in 1 CARTON
110 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/22/2013
Labeler - Kroger Company (006999528)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc603980319MANUFACTURE(30142-327), ANALYSIS(30142-327), STERILIZE(30142-327), PACK(30142-327), LABEL(30142-327)

Revised: 2/2013
 
Kroger Company

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