Retaine Cmc Solution/ Drops
FDA Label NDC 54799-460

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ocusoft Inc. for the product Retaine Cmc (NDC 54799-460). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Carboxymethylcellulose sodium (0.5%)

Purpose

Eye lubricant

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.

Warnings

For use in the eyes only.

Do Not Use

if solution changes color or becomes cloudy.

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.

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.

Questions Or Comments?

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

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-Dose Containers
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-dose
container 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 R05/24

Carton (Carton1)

Carton (Carton1)

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