Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 5f74b161-ae41-d0e2-6ed9-8deca55d2c0f
Route
OPHTHALMIC
Published
Effective Date 2022-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hypromellose 2910 (4000 Mpa.s) (3 mg)
Inactive Ingredients
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Phosphonic Acid Water Sodium Perborate Sorbitol Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-12-15 Until 2018-12-31

Description

Active ingredient Purpose Hypromellose (0.3%) Lubricant


Medication Information

Description

Active ingredient Purpose Hypromellose (0.3%) Lubricant

Uses
  • for the temporary relief of burning and irritation due to dryness of the eye
  • for use as a protectant against further irritation or to relieve dryness of the eye
Section 50566-9

Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye

  • condition worsens or persists for more than 72 hours

Section 55105-1
Active ingredient Purpose
Hypromellose (0.3%) Lubricant
Warnings

For external use only

Directions
  • put 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
Questions?

In the U.S. call 1-800-757-9195

[email protected]

www.systane.com

Other Information
  • store at room temperature
Inactive Ingredients

carbopol 980, phosphonic acid, purified water, sodium perborate and sorbitol. May contain sodium hydroxide to adjust pH.

Principal Display Panel

Systane® 

LUBRICANT EYE GEL



NIGHT GEL



COMFORTING

DRY EYE RELIEF




Long lasting gel

for nighttime use




Soothing relief



#1 DOCTOR RECOMMENDED BRAND1

 

GEL



Alcon




STERILE 10g

(0.35 OZ)



TAMPER EVIDENT: For your

protection, use only if pull tab is

intact at time of purchase.



www.alconpatents.com



1 Based on a survey of eye care

professionals. Data on file.



Processed in France with

US-origin active ingredient for:

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



25368501-0519



25368501

LOT / EXP

When Using This Product
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after using
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
  • for use as a protectant against further irritation or to relieve dryness of the eye
Section 50566-9 (50566-9)

Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye

  • condition worsens or persists for more than 72 hours

Section 55105-1 (55105-1)
Active ingredient Purpose
Hypromellose (0.3%) Lubricant
Warnings

For external use only

Directions
  • put 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
Questions?

In the U.S. call 1-800-757-9195

[email protected]

www.systane.com

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

carbopol 980, phosphonic acid, purified water, sodium perborate and sorbitol. May contain sodium hydroxide to adjust pH.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Systane® 

LUBRICANT EYE GEL



NIGHT GEL



COMFORTING

DRY EYE RELIEF




Long lasting gel

for nighttime use




Soothing relief



#1 DOCTOR RECOMMENDED BRAND1

 

GEL



Alcon




STERILE 10g

(0.35 OZ)



TAMPER EVIDENT: For your

protection, use only if pull tab is

intact at time of purchase.



www.alconpatents.com



1 Based on a survey of eye care

professionals. Data on file.



Processed in France with

US-origin active ingredient for:

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



25368501-0519



25368501

LOT / EXP

When Using This Product (When using this product)
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after using
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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