SPL v1
SPL
SPL Set ID 1b02a39e-1960-2ca6-e054-00144ff8d46c
Route
OPHTHALMIC
Published
Effective Date 2015-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 400 (4 mg) Propylene Glycol (3 mg)
Inactive Ingredients
Water Sorbitol Boric Acid Sodium Chloride Potassium Chloride Hydrochloric Acid Sodium Hydroxide Benzalkonium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-07-16

Description

Drug Facts

Purpose

Lubricant Lubricant


Medication Information

Purpose

Lubricant

Lubricant

Description

Drug Facts

Uses

For the temporary relief of burning and irritation due to dryness of the eye.

Section 42229-5

Drug Facts

Section 51945-4

Principal Display Panel Text for Carton Label:

Well at

WALGREENS PHARMACIST RECOMMENDED≠

STERILE

Lubricant

Eye Drops

Polyethylene

Glycol 400 0.4%

Propylene Glycol 0.3%

  • For temporary relief of

    burning & irritation due

    to dryness of the eye

Compare to Systane ® Ultra active ingredient#

0.3 FL OZ (10 mL)

Warnings

For external use only.

Directions
  • shake well before using
  • instill 1 or 2 drops in the affected eye(s) as needed
Do Not Use
  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
Other Information

Store at room temperature.

Active Ingredients

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

Inactive Ingredients

benzalkonium chloride, boric acid, hydroxyethyl cellulose, potassium chloride, purified water, sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions Or Comments?

1-800-883-0085

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.


Structured Label Content

Uses

For the temporary relief of burning and irritation due to dryness of the eye.

Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

Principal Display Panel Text for Carton Label:

Well at

WALGREENS PHARMACIST RECOMMENDED≠

STERILE

Lubricant

Eye Drops

Polyethylene

Glycol 400 0.4%

Propylene Glycol 0.3%

  • For temporary relief of

    burning & irritation due

    to dryness of the eye

Compare to Systane ® Ultra active ingredient#

0.3 FL OZ (10 mL)

Purpose

Lubricant

Lubricant

Warnings

For external use only.

Directions
  • shake well before using
  • instill 1 or 2 drops in the affected eye(s) as needed
Do Not Use (Do not use)
  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
Other Information (Other information)

Store at room temperature.

Active Ingredients (Active ingredients)

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, boric acid, hydroxyethyl cellulose, potassium chloride, purified water, sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions Or Comments? (Questions or comments?)

1-800-883-0085

When Using 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 (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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