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SPL v12
SPL
SPL Set ID 0f6a4b4b-cde6-4518-84b5-ce997f1154a7
Route
ophthalmic
Published
Effective Date 2022-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
carboxymethylcellulose (5 mg)
Inactive Ingredients
calcium chloride magnesium chloride potassium chloride water sodium chloride sodium lactate hydrochloric acid sodium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 1996-10-09

Purpose

Eye lubricant

Description

Carboxymethylcellulose sodium 0.5%


Medication Information

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.
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

Directions

To open, TWIST AND PULL TAB TO REMOVE . 

Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

*Follow your eye doctor’s instructions if you are using this product after an eye surgery (e.g., LASIK) to relieve eye dryness and discomfort.

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

Calcium chloride dihydrate; magnesium chloride hexahydrate; potassium chloride; purified water; sodium chloride; and sodium lactate. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Description

Carboxymethylcellulose sodium 0.5%

Principal Display Panel

NDC 0023-0403-30

Preservative-free

Refresh

Plus
®

Lubricant Eye Drops

For Eye Dryness

MOISTURIZING RELIEF 

Original Strength

Lubricates & Moisturizes

Recommended for Sensitive Eyes

30 Single-Use Containers

0.01 fl oz (0.4 mL) each Sterile

Active Ingredient

Carboxymethylcellulose sodium 0.5%

Questions Or Comments?

1.800. 678.1605

refreshbrand.com

v1.0DFL0403

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

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.
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

Directions

To open, TWIST AND PULL TAB TO REMOVE . 

Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

*Follow your eye doctor’s instructions if you are using this product after an eye surgery (e.g., LASIK) to relieve eye dryness and discomfort.

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)

Calcium chloride dihydrate; magnesium chloride hexahydrate; potassium chloride; purified water; sodium chloride; and sodium lactate. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 0023-0403-30

Preservative-free

Refresh

Plus
®

Lubricant Eye Drops

For Eye Dryness

MOISTURIZING RELIEF 

Original Strength

Lubricates & Moisturizes

Recommended for Sensitive Eyes

30 Single-Use Containers

0.01 fl oz (0.4 mL) each Sterile

Active Ingredient (Active ingredient)

Carboxymethylcellulose sodium 0.5%

Questions Or Comments? (Questions or comments?)

1.800. 678.1605

refreshbrand.com

v1.0DFL0403

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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