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SPL v11
SPL
SPL Set ID 80275190-d717-40ea-905b-5c8fbe986eac
Route
OPHTHALMIC
Published
Effective Date 2025-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carboxymethylcellulose (10 mg) Glycerin (9 mg)
Inactive Ingredients
Boric Acid Calcium Chloride Erythritol Levocarnitine Magnesium Chloride Potassium Chloride Water Sodium Borate Sodium Chlorite Trisodium Citrate Dihydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-09-30

Description

Carboxymethylcellulose sodium 1% Glycerin 0.9%

Purpose

Eye lubricant Eye lubricant


Medication Information

Purpose

Eye lubricant

Eye lubricant

Description

Carboxymethylcellulose sodium 1% 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.

  • 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.

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.
Active Ingredients

Carboxymethylcellulose sodium 1%

Glycerin 0.9%

Inactive Ingredients

Boric acid; calcium chloride dihydrate; erythritol; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; PURITE® (stabilized oxychloro complex); sodium borate decahydrate; and sodium citrate dihydrate.

Questions Or Comments?

1.800.678.1605

r efresh eyedrops .com

v2.0DFL5459

Principal Display Panel

NDC 0023-5459-10

Refresh

Optive ®

GEL DROPS

Lubricant Eye Gel

Extended
Relief



Lasting comfort Day or Night

0.33
fl oz (10 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

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.

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.
Active Ingredients (Active ingredients)

Carboxymethylcellulose sodium 1%

Glycerin 0.9%

Inactive Ingredients (Inactive ingredients)

Boric acid; calcium chloride dihydrate; erythritol; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; PURITE® (stabilized oxychloro complex); sodium borate decahydrate; and sodium citrate dihydrate.

Questions Or Comments? (Questions or comments?)

1.800.678.1605

r efresh eyedrops .com

v2.0DFL5459

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 0023-5459-10

Refresh

Optive ®

GEL DROPS

Lubricant Eye Gel

Extended
Relief



Lasting comfort Day or Night

0.33
fl oz (10 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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