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SPL v3
SPL
SPL Set ID 97e83e68-6374-4df4-93f6-d707fc32748d
Route
OPHTHALMIC
Published
Effective Date 2022-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carboxymethylcellulose (5 mg) Glycerin (10 mg) Polysorbate 80
Inactive Ingredients
Boric Acid Carbomer Copolymer Type A Castor Oil Erythritol Levocarnitine Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-01

Description

Carboxymethylcellulose sodium 0.5% Glycerin 1% Polysorbate 80 0.5%

Purpose

Eye lubricant Eye lubricant Eye lubricant


Medication Information

Purpose

Eye lubricant

Eye lubricant

Eye lubricant

Description

Carboxymethylcellulose sodium 0.5% Glycerin 1% Polysorbate 80 0.5%

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, 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

Carboxymethylcellulose sodium 0.5%

Glycerin 1%

Polysorbate 80 0.5%

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

Boric acid; carbomer copolymer type A; castor oil; erythritol; levocarnitine; purified water; and sodium hydroxide (to adjust pH).

Questions Or Comments?

  1.800. 678.1605

refreshbrand.com

v1.0DFL6954

Principal Display Panel

NDC 0023-6954-30

Refresh ®

DIGITAL PF

Lubricant Eye Drops

For Eye Dryness


with   HydroCell

Fast-acting Relief

That Soothes Your Eyes

30 Vials (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

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, 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)

Carboxymethylcellulose sodium 0.5%

Glycerin 1%

Polysorbate 80 0.5%

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)

Boric acid; carbomer copolymer type A; castor oil; erythritol; levocarnitine; purified water; and sodium hydroxide (to adjust pH).

Questions Or Comments? (Questions or comments?)

  1.800. 678.1605

refreshbrand.com

v1.0DFL6954

Principal Display Panel

NDC 0023-6954-30

Refresh ®

DIGITAL PF

Lubricant Eye Drops

For Eye Dryness


with   HydroCell

Fast-acting Relief

That Soothes Your Eyes

30 Vials (0.01 fl oz (0.4 mL) each Sterile

Stop Use and Ask A Doctor (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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