retaine®

retaine®
SPL v2
SPL
SPL Set ID a3698c71-0c80-4246-be52-5e7d96f6c540
Route
ophthalmic
Published
Effective Date 2025-02-27
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 2025-01-13

Purpose

Eye lubricant

Description

Carboxymethylcellulose sodium (0.5%)


Medication Information

Warnings

For use in the eyes only.

Uses
  • Relieves dryness of the eye.
  • Temporarily relieves discomfort due to minor irritations of the eye or from exposure to wind or sun.
  • As a protectant against further irritation.
Purpose

Eye lubricant

Directions
  • Instill 1 or 2 drops into affected eye(s) as needed and discard container.
Other Information
  • Use only if tamper seal on top and bottom flaps are intact.
  • Store between 15°-30°C (59°-86°F).
  • Keep carton for complete product information.
Inactive Ingredients

Calcium chloride, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium lactate. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Description

Carboxymethylcellulose sodium (0.5%)

Do Not Use

if solution changes color or becomes cloudy.

Active Ingredient

Carboxymethylcellulose sodium (0.5%)

Questions Or Comments?

(800) 233-5469 M-F 8:30-5:00PM CST or visit www.ocusoft.com

When Using This Product
  • do not touch tip of container to any surface to avoid contamination.
  • do not reuse once opened.
Stop Use and Ask A Doctor If
  • you experience eye pain, changes in vision, continued redness or irritation of the eye.
  • 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 immediately.

Package Label.principal Display Panel

NDC 54799-460-30



OCuSOFT®



LUBRICANT

EYE DROPS



Carboxymethylcellulose Sodium 0.5%



PRESERVATIVE-FREE



Restores Moisture



For Immediate

Long-Lasting Relief

of Dry Eyes




OCuSOFT®



30 Sterile

Single-Use Vials

0.01 fl oz (0.4 mL) each




Retaine® CMC® Lubricant Eye

Drops provides immediate relief for

dry, scratchy, irritated eyes which

can be caused by excessive heat,

air conditioning, reading,

medications or prolonged computer

use. The soothing formula utilizes

Carboxymethylcellulose (CMC) to

restore moisture with the same

healthy quality as natural tears and

is preservative-free to eliminate

the risk of irritation caused by

preservatives found in other eye

drops.



DIRECTIONS FOR USE



1. To open, twist top and pull to

remove.



2. Instill 1 or 2 drops into affected

eye(s) as needed and discard

container.



NOT ACTUAL SIZE



Use only if twist top of single-use

vial is intact.




Manufactured for OCuSOFT Inc.

Rosenberg, TX 77471 USA



© 2024 OCuSOFT Inc.

www.ocusoft.com

Retaine® and CMC® are registered

trademarks of OCuSOFT Inc.



777-4-60 R02/25


Structured Label Content

Warnings

For use in the eyes only.

Uses
  • Relieves dryness of the eye.
  • Temporarily relieves discomfort due to minor irritations of the eye or from exposure to wind or sun.
  • As a protectant against further irritation.
Purpose

Eye lubricant

Directions
  • Instill 1 or 2 drops into affected eye(s) as needed and discard container.
Other Information (Other information)
  • Use only if tamper seal on top and bottom flaps are intact.
  • Store between 15°-30°C (59°-86°F).
  • Keep carton for complete product information.
Inactive Ingredients (Inactive ingredients)

Calcium chloride, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium lactate. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Do Not Use (Do not use)

if solution changes color or becomes cloudy.

Active Ingredient (Active ingredient)

Carboxymethylcellulose sodium (0.5%)

Questions Or Comments? (Questions or comments?)

(800) 233-5469 M-F 8:30-5:00PM CST or visit www.ocusoft.com

When Using This Product (When using this product)
  • do not touch tip of container to any surface to avoid contamination.
  • do not reuse once opened.
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.
  • 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 immediately.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 54799-460-30



OCuSOFT®



LUBRICANT

EYE DROPS



Carboxymethylcellulose Sodium 0.5%



PRESERVATIVE-FREE



Restores Moisture



For Immediate

Long-Lasting Relief

of Dry Eyes




OCuSOFT®



30 Sterile

Single-Use Vials

0.01 fl oz (0.4 mL) each




Retaine® CMC® Lubricant Eye

Drops provides immediate relief for

dry, scratchy, irritated eyes which

can be caused by excessive heat,

air conditioning, reading,

medications or prolonged computer

use. The soothing formula utilizes

Carboxymethylcellulose (CMC) to

restore moisture with the same

healthy quality as natural tears and

is preservative-free to eliminate

the risk of irritation caused by

preservatives found in other eye

drops.



DIRECTIONS FOR USE



1. To open, twist top and pull to

remove.



2. Instill 1 or 2 drops into affected

eye(s) as needed and discard

container.



NOT ACTUAL SIZE



Use only if twist top of single-use

vial is intact.




Manufactured for OCuSOFT Inc.

Rosenberg, TX 77471 USA



© 2024 OCuSOFT Inc.

www.ocusoft.com

Retaine® and CMC® are registered

trademarks of OCuSOFT Inc.



777-4-60 R02/25


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