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lubricating relief

Kroger Company
Akorn, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 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)

lubricating relief

Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS

Product Information

Product Type Human otc drug label 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 Polyethylene Glycol 400 4 mg
propylene glycol Propylene Glycol 3 mg

Inactive Ingredients

Ingredient Name Strength
water
sorbitol
BORIC ACID
Aminomethylpropanol
HYPROMELLOSES
SODIUM CHLORIDE
potassium chloride
HYDROCHLORIC ACID
SODIUM HYDROXIDE
benzalkonium chloride

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BOTTLE, DROPPER
2 NDC:30142-327-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2013-02-22


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