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SPL v10
SPL
SPL Set ID 31bf1d6c-9719-4060-b6a3-409a2fe7b560
Route
OPHTHALMIC
Published
Effective Date 2022-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyvinyl Alcohol, Unspecified (14 mg) Povidone (6 mg)
Inactive Ingredients
Water Sodium Chloride Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1985-09-12

Description

Polyvinyl Alcohol 1.4% Povidone 0.6%

Purpose

Eye lubricant Eye lubricant


Medication Information

Purpose

Eye lubricant

Eye lubricant

Description

Polyvinyl Alcohol 1.4% Povidone 0.6%

Uses
  • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.

  • May be used as a protectant against further irritation.
Warnings
  • For external use only.

  • To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard .

  • Do not touch unit-dose tip to eye.

  • If solution changes color or becomes cloudy , do not use.
Directions

To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

Active Ingredient

Polyvinyl Alcohol 1.4%

Povidone 0.6%

Other Information
  • Use only if single-use container is intact.

  • Use before expiration date marked on container.

  • Store at 59°-77°F (15°-25°C).

  • RETAIN THIS CARTON FOR FUTURE REFERENCE.
Inactive Ingredients

Purified water and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions Or Comments?

1.800. 678.1605

refreshbrand.com

v1.0DFL0506

Principal Display Panel

NDC 0023-0506-01

Preservative-free

Refresh ®

Classic

Lubricant Eye Drops

Moistur izing Relief for

D ry , Irritated   E yes

30 Single-Use Containers

0.01
fl oz (0.4 mL) each Sterile

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.

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, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.

  • May be used as a protectant against further irritation.
Purpose

Eye lubricant

Eye lubricant

Warnings
  • For external use only.

  • To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard .

  • Do not touch unit-dose tip to eye.

  • If solution changes color or becomes cloudy , do not use.
Directions

To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

Active Ingredient (Active ingredient)

Polyvinyl Alcohol 1.4%

Povidone 0.6%

Other Information (Other information)
  • Use only if single-use container is intact.

  • Use before expiration date marked on container.

  • Store at 59°-77°F (15°-25°C).

  • RETAIN THIS CARTON FOR FUTURE REFERENCE.
Inactive Ingredients (Inactive ingredients)

Purified water and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions Or Comments? (Questions or comments?)

1.800. 678.1605

refreshbrand.com

v1.0DFL0506

Principal Display Panel

NDC 0023-0506-01

Preservative-free

Refresh ®

Classic

Lubricant Eye Drops

Moistur izing Relief for

D ry , Irritated   E yes

30 Single-Use Containers

0.01
fl oz (0.4 mL) each Sterile

Stop Use and Ask A Doctor If (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.

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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