SPL v5
SPL
SPL Set ID b6bf402a-fe57-4998-b85e-a262c25e745a
Route
OPHTHALMIC
Published
Effective Date 2022-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyvinyl Alcohol, Unspecified (14 mg)
Inactive Ingredients
Benzalkonium Chloride Edetate Disodium Sodium Chloride Sodium Phosphate, Dibasic, Anhydrous Sodium Phosphate, Monobasic, Anhydrous Water Sodium Hydroxide Hydrochloric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-03-23

Description

Drug Facts

Purpose

Eye lubricant


Medication Information

Purpose

Eye lubricant

Description

Drug Facts

Uses

For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Section 51945-4

Principal Display Panel Text for Container Label:

NDC 13985-601-15

Artificial Tears

Solution

Polyvinyl Alcohol 1.4%

STERILE

Lubricant Eye Drops

Apexa logo

AP 704002 15 mL

Warnings
  • Do not use if imprinted seal on the bottle neck is broken or missing.
  • Do not use if solution changes color or becomes cloudy.
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.
Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Questions?

call toll-free 1-800-932-5676.

Active Ingredient

Polyvinyl Alcohol 1.4%

Other Information
  • Store at 20° to 25°C (68° to 77°F)

    [see USP Controlled Room Temperature].
  • Store away from heat.
  • Protect from freezing.
  • Keep tightly closed. RETAIN THIS CARTON FOR FUTURE REFERENCE.
Inactive Ingredients

Benzalkonium Chloride 0.005% (preservative), Edetate Disodium, Sodium Chloride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.


Structured Label Content

Uses

For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Section 51945-4 (51945-4)

Principal Display Panel Text for Container Label:

NDC 13985-601-15

Artificial Tears

Solution

Polyvinyl Alcohol 1.4%

STERILE

Lubricant Eye Drops

Apexa logo

AP 704002 15 mL

Purpose

Eye lubricant

Warnings
  • Do not use if imprinted seal on the bottle neck is broken or missing.
  • Do not use if solution changes color or becomes cloudy.
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.
Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Questions?

call toll-free 1-800-932-5676.

Active Ingredient (Active ingredient)

Polyvinyl Alcohol 1.4%

Other Information (Other information)
  • Store at 20° to 25°C (68° to 77°F)

    [see USP Controlled Room Temperature].
  • Store away from heat.
  • Protect from freezing.
  • Keep tightly closed. RETAIN THIS CARTON FOR FUTURE REFERENCE.
Inactive Ingredients (Inactive ingredients)

Benzalkonium Chloride 0.005% (preservative), Edetate Disodium, Sodium Chloride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)