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SPL v4
SPL
SPL Set ID 9e1cba7b-84ed-47f3-b19a-121992834350
Route
OPHTHALMIC
Published
Effective Date 2025-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carboxymethylcellulose (5 mg) Glycerin (9 mg)
Inactive Ingredients
Boric Acid Calcium Chloride Erythritol Levocarnitine Magnesium Chloride Potassium Chloride Water Sodium Borate Trisodium Citrate Dihydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-01

Description

Carboxymethylcellulose sodium 0.5% Glycerin 0.9%

Purpose

Eye lubricant Eye lubricant


Medication Information

Purpose

Eye lubricant

Eye lubricant

Description

Carboxymethylcellulose sodium 0.5% Glycerin 0.9%

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

  • For use as a protectant against further irritation or to relieve dryness of the eye.
Warnings
  • For external use only.

  • To avoid contamination, do not touch tip of container to any surface. Replace cap after using.

  • If solution changes color   or becomes cloudy , do not use.
Directions
  • Instill 1 or 2 drops in the affected eye(s) as needed.

  • Prior to first use, please read the “Instructions For Use” inside this carton.
Active Ingredient

Carboxymethylcellulose sodium 0.5%

Glycerin 0.9%

Other Information
  • Use only if tape seals on top and bottom flaps are intact.

  • Use before expiration date marked on container.

  • Discard 90 days after opening.

  • Store at 59°-77°F (15°-25°C).

  • RETAIN THIS CARTON AND THE INSERT FOR FUTURE REFERENCE.
Inactive Ingredients

Boric acid; calcium chloride dihydrate; erythritol; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; sodium borate decahydrate; and sodium citrate dihydrate.

Questions Or Comments?

1.800. 6 78 . 1605

refresh eyedrops .com

v2.0DFL3110

Principal Display Panel

NDC 0023-3110-10

PRESERVATIVE - FREE

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Tears ®   PF

Lubricating Eye Drops

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.

  • For use as a protectant against further irritation or to relieve dryness of the eye.
Purpose

Eye lubricant

Eye lubricant

Warnings
  • For external use only.

  • To avoid contamination, do not touch tip of container to any surface. Replace cap after using.

  • If solution changes color   or becomes cloudy , do not use.
Directions
  • Instill 1 or 2 drops in the affected eye(s) as needed.

  • Prior to first use, please read the “Instructions For Use” inside this carton.
Active Ingredient (Active ingredient)

Carboxymethylcellulose sodium 0.5%

Glycerin 0.9%

Other Information (Other information)
  • Use only if tape seals on top and bottom flaps are intact.

  • Use before expiration date marked on container.

  • Discard 90 days after opening.

  • Store at 59°-77°F (15°-25°C).

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

Boric acid; calcium chloride dihydrate; erythritol; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; sodium borate decahydrate; and sodium citrate dihydrate.

Questions Or Comments? (Questions or comments?)

1.800. 6 78 . 1605

refresh eyedrops .com

v2.0DFL3110

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 0023-3110-10

PRESERVATIVE - FREE

Refresh

Tears ®   PF

Lubricating Eye Drops

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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