Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 89302e2b-882b-48d5-8df7-be37859b48ba
Route
OPHTHALMIC
Published
Effective Date 2023-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hypromellose 2910 (4000 Mpa.s) (5 mg)
Inactive Ingredients
Benzalkonium Chloride Sodium Phosphate, Dibasic, Unspecified Form Sodium Phosphate, Monobasic, Unspecified Form Water Sodium Chloride Sodium Citrate, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-01

Description

Active i ngredients Purpose Hypromellose 2910 0.5% Lubricant


Medication Information

Description

Active i ngredients Purpose Hypromellose 2910 0.5% Lubricant

Uses
  • for the temporary relief of burning and irritation due to dryness of the eye
  • for use as a protectant against further irritation
Section 55105-1
Active i ngredients Purpose
Hypromellose 2910 0.5% Lubricant
Warnings

For external use only

Directions
  • instill 1 or 2 drops in the affected eye(s) as needed
Do Not Use
  • if this solution 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

Other Information
  • store at room temperature
Inactive Ingredients

benzalkonium chloride 0.01% as preservative, dibasic sodium phosphate, monobasic sodium phosphate, purified water, sodium chloride, sodium citrate

Principal Display Panel

Alcon Tears



LUBRICANT

Eye Drops



For Relief of Dry Eye Symptoms



STERILE




15 mL (1/2 FL OZ)



Alcon



TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck.

Do not use if seal is damaged or missing at time of purchase.




Alcon

ALCON LABORATORIES, INC.


Fort Worth, Texas 76134 USA



Printed in USA

When Using This Product
  • remove contact lenses before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after each use
Stop Use and Ask A Doctor If

you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation
  • condition worsens or persists for 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
  • for use as a protectant against further irritation
Section 55105-1 (55105-1)
Active i ngredients Purpose
Hypromellose 2910 0.5% Lubricant
Warnings

For external use only

Directions
  • instill 1 or 2 drops in the affected eye(s) as needed
Do Not Use (Do not use)
  • if this solution 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

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

benzalkonium chloride 0.01% as preservative, dibasic sodium phosphate, monobasic sodium phosphate, purified water, sodium chloride, sodium citrate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Alcon Tears



LUBRICANT

Eye Drops



For Relief of Dry Eye Symptoms



STERILE




15 mL (1/2 FL OZ)



Alcon



TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck.

Do not use if seal is damaged or missing at time of purchase.




Alcon

ALCON LABORATORIES, INC.


Fort Worth, Texas 76134 USA



Printed in USA

When Using This Product (When using this product)
  • remove contact lenses before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after each use
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation
  • condition worsens or persists for 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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