Refresh Re

Refresh Re
SPL v7
SPL
SPL Set ID 3481f9b3-5a90-40d3-80f8-81f51cc864be
Route
OPHTHALMIC
Published
Effective Date 2025-10-22
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 Hyaluronate Sodium Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-26

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.

  • May be used as a protectant against further irritation.
Warnings
  • For external use only.

  • To avoid contamination, do not touch tip of contai ner 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, bottle must be primed. Please read the “Instructions For Use” on the insert inside this carton.

  • *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 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.
Active Ingredients

Carboxymethylcellulose sodium 0.5%

Glycerin 0.9%

Inactive Ingredients

Boric acid; calcium chloride dihydrate; erythritol; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; sodium borate decahydrate; sodium citrate dihydrate; and sodium hyaluronate. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions Or Comments?

v2.0DFL6634

Principal Display Panel

NDC: 0023-6634-10

PRESERVATIVE-FREE



Refresh ®

R ELIEVA ® PF

Lubricant Eye Drops

With Hydrocell ®

Lubricates &Protects



Dry,Sensitive Eyes



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 contai ner 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, bottle must be primed. Please read the “Instructions For Use” on the insert inside this carton.

  • *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 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.
Active Ingredients (Active ingredients)

Carboxymethylcellulose sodium 0.5%

Glycerin 0.9%

Inactive Ingredients (Inactive ingredients)

Boric acid; calcium chloride dihydrate; erythritol; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; sodium borate decahydrate; sodium citrate dihydrate; and sodium hyaluronate. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions Or Comments? (Questions or comments?)

v2.0DFL6634

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC: 0023-6634-10

PRESERVATIVE-FREE



Refresh ®

R ELIEVA ® PF

Lubricant Eye Drops

With Hydrocell ®

Lubricates &Protects



Dry,Sensitive Eyes



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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