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SPL v9
SPL
SPL Set ID 329d1fe0-4432-4565-b7b1-65666bd86526
Route
OPHTHALMIC
Published
Effective Date 2022-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carboxymethylcellulose (5 mg)
Inactive Ingredients
Boric Acid Calcium Chloride Magnesium Chloride Potassium Chloride Water Sodium Chlorite Sodium Chlorate Chlorine Dioxide Sodium Borate Sodium Chloride Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2000-01-01 Until 2018-01-27

Description

Carboxymethylcellulose sodium 0.5%

Purpose

Eye lubricant


Medication Information

Purpose

Eye lubricant

Description

Carboxymethylcellulose sodium 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. 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.

Active Ingredient

Carboxymethylcellulose sodium 0.5%

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 FOR FUTURE REFERENCE.
Inactive Ingredients

Boric acid; calcium chloride dihydrate; magnesium chloride hexahydrate; potassium chloride; purified water; PURITE® (stabilized oxychloro complex); sodium borate decahydrate; and sodium chloride. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions Or Comments?

1.800. 6 78 . 1605

refreshbrand.com

v1.0DFL0798

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Tears®

Lubricant Eye Drops

ORIGINAL STRENGTH

Moisturizing Relief for

Dry, Irritated Eyes

0.5 fl oz (15 mL) 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

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.

Active Ingredient (Active ingredient)

Carboxymethylcellulose sodium 0.5%

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 FOR FUTURE REFERENCE.
Inactive Ingredients (Inactive ingredients)

Boric acid; calcium chloride dihydrate; magnesium chloride hexahydrate; potassium chloride; purified water; PURITE® (stabilized oxychloro complex); sodium borate decahydrate; and sodium chloride. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions Or Comments? (Questions or comments?)

1.800. 6 78 . 1605

refreshbrand.com

v1.0DFL0798

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Refresh

Tears®

Lubricant Eye Drops

ORIGINAL STRENGTH

Moisturizing Relief for

Dry, Irritated Eyes

0.5 fl oz (15 mL) 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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