SPL v5
SPL
SPL Set ID 2ef16864-97cb-4dfe-9461-cba156144c69
Route
OPHTHALMIC
Published
Effective Date 2015-06-15
Document Type 50577-6 OTC ANIMAL 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
UNAPPROVED DRUG OTHER Active Since 2015-06-15

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 51945-4

Principal Display Panel Text for Container Label:

NDC 59399-160-15

15 mL

ARTIFICIAL

TEARS

SOLUTION

Polyvinyl Alcohol 1.4%

Lubricant Eye Drops

For Veterinary Use

Sterile

15 mL (0.5 fl. oz.)

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 USP, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.

Stop Use and Ask A Doctor If

condition persists or increases discontinue use and consult a veterinarian.

Keep Out of the Reach of Children.

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


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 51945-4 (51945-4)

Principal Display Panel Text for Container Label:

NDC 59399-160-15

15 mL

ARTIFICIAL

TEARS

SOLUTION

Polyvinyl Alcohol 1.4%

Lubricant Eye Drops

For Veterinary Use

Sterile

15 mL (0.5 fl. oz.)

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 USP, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition persists or increases discontinue use and consult a veterinarian.

Keep Out of the Reach of Children. (Keep out of the 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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