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SPL v8
SPL
SPL Set ID c5f2b3f2-2071-45bd-a010-67f848bc0233
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) Glycerin (10 mg) Polysorbate 80
Inactive Ingredients
Boric Acid Butylated Hydroxytoluene Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Castor Oil Erythritol Linseed Oil Levocarnitine Polyoxyl Stearate 40 Water Trehalose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-01
Description

Carboxymethylcellulose sodium 0.5% Glycerin 1% Polysorbate 80 0.5%

Purpose

Eye lubricant Eye lubricant Eye lubricant

Medication Information

Purpose

Eye lubricant

Eye lubricant

Eye lubricant

Description

Carboxymethylcellulose sodium 0.5% Glycerin 1% Polysorbate 80 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. Do not   reuse. Once opened, discard.

  • Do not touch unit-dose tip to eye.

  • If solution changes color, do not use.
Directions

To open, TWIST AND PULL TAB TO REMOVE.

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

  • Store vials in the pouch until use.

  • RETAIN THIS CARTON FOR FUTURE REFERENCE.
Active Ingredients

Carboxymethylcellulose sodium 0.5%

Glycerin 1%

Polysorbate 80 0.5%

Inactive Ingredients

Boric acid; butylated hydroxyl toluene; carbomer copolymer type A; castor oil; erythritol; flaxseed oil; levocarnitine; polyoxyl 40 stearate; purified water; and trehalose. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions Or Comments?

1.800.678.1605

refresheyedrops.com

v2.0DFL5773

Principal Display Panel

NDC 0023-5773-30

PRESERVATIVE - FREE

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OPTIVE  

MEGA-3 ®

Lubricant Eye Drops  

with

HydroCell ®

Fast-Acting Dry Eye Relief

Enhanced With Flaxseed Oil*

30 Vials 0.01 fl oz (0.4 mL) each 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

Eye lubricant

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, do not use.
Directions

To open, TWIST AND PULL TAB TO REMOVE.

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

  • Store vials in the pouch until use.

  • RETAIN THIS CARTON FOR FUTURE REFERENCE.
Active Ingredients (Active ingredients)

Carboxymethylcellulose sodium 0.5%

Glycerin 1%

Polysorbate 80 0.5%

Inactive Ingredients (Inactive ingredients)

Boric acid; butylated hydroxyl toluene; carbomer copolymer type A; castor oil; erythritol; flaxseed oil; levocarnitine; polyoxyl 40 stearate; purified water; and trehalose. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions Or Comments? (Questions or comments?)

1.800.678.1605

refresheyedrops.com

v2.0DFL5773

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 0023-5773-30

PRESERVATIVE - FREE

Refresh

OPTIVE  

MEGA-3 ®

Lubricant Eye Drops  

with

HydroCell ®

Fast-Acting Dry Eye Relief

Enhanced With Flaxseed Oil*

30 Vials 0.01 fl oz (0.4 mL) each 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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:23.712288 · Updated: 2026-03-14T23:09:09.169888