NDC 54799-897 Retaine Cmc Lubricant Eye Drops

Carboxymethylcellulose Sodium

NDC Product Code 54799-897

NDC CODE: 54799-897

Proprietary Name: Retaine Cmc Lubricant Eye Drops What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Carboxymethylcellulose Sodium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to relieve dry, irritated eyes. Common causes for dry eyes include wind, sun, heating/air conditioning, computer use/reading, and certain medications. This product may contain 1 or more of the following ingredients: carboxymethylcellulose, dextran, glycerin, hypromellose, polyethylene glycol 400 (PEG 400), polysorbate, polyvinyl alcohol, povidone, or propylene glycol, among others. Eye lubricants keep the eye moist, help to protect the eye from injury and infection, and decrease symptoms of dry eyes such as burning, itching, and feeling as if something is in the eye.

NDC Code Structure

  • 54799 - Ocusoft Inc.

NDC 54799-897-30

Package Description: 30 VIAL, SINGLE-DOSE in 1 CONTAINER > .4 mL in 1 VIAL, SINGLE-DOSE

NDC Product Information

Retaine Cmc Lubricant Eye Drops with NDC 54799-897 is a a human over the counter drug product labeled by Ocusoft Inc.. The generic name of Retaine Cmc Lubricant Eye Drops is carboxymethylcellulose sodium. The product's dosage form is solution and is administered via ophthalmic form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1188426.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Retaine Cmc Lubricant Eye Drops Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • WATER (UNII: 059QF0KO0R)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ocusoft Inc.
Labeler Code: 54799
FDA Application Number: part349 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-01-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Retaine Cmc Lubricant Eye Drops Product Label Images

Retaine Cmc Lubricant Eye Drops Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Carboxymethylcellulose sodium 0.5%................................. 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 The Reach Of Children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • To open, TWIST AND PULL TAB TO REMOVE.Instill 1 or 2 drops into affected eye(s) as needed and discard container.

Other Information

  • Use only if printed tamper seals on top and bottom flaps are intact.Use only if twist top of single-dose container is intact.Store between 15º-30ºC (59º-86ºF).

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.

Purpose

Eye Lubricant

* Please review the disclaimer below.