NDC 54799-895 Retaine Nacl

Boric Acid, Hypromelloses, Methylparaben, Propylene Glycol, Propylparaben, Sodium Borate, Water, Sodium Hydroxide And/or Hydrochloric Acid

NDC Product Code 54799-895

NDC Code: 54799-895

Proprietary Name: Retaine Nacl 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: Boric Acid, Hypromelloses, Methylparaben, Propylene Glycol, Propylparaben, Sodium Borate, Water, Sodium Hydroxide And/or Hydrochloric Acid 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.

NDC Code Structure

  • 54799 - Ocusoft, Inc.

NDC 54799-895-35

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 15 mL in 1 BOTTLE, DROPPER

NDC Product Information

Retaine Nacl with NDC 54799-895 is a a human over the counter drug product labeled by Ocusoft, Inc.. The generic name of Retaine Nacl is boric acid, hypromelloses, methylparaben, propylene glycol, propylparaben, sodium borate, water, sodium hydroxide and/or hydrochloric acid. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Ocusoft, Inc.

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 Nacl 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.

  • SODIUM CHLORIDE 50 mg/mL

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.

  • BORIC ACID (UNII: R57ZHV85D4)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)

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: 08-28-2015 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

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Retaine Nacl Product Label Images

Retaine Nacl 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

Otc - Purpose

Active ingredientPurposeSodium chloride (5%)Hypertonicity agent

Use

For the temporary relief of corneal edema.

Warnings

For use in the eyes only.

Do Not Use

  • Except under the advice and supervision of a doctor. if solution changes color or becomes cloudy.

When Using This Product

  • It may cause temporary burning and irritation.do not touch tip of container to any surface to avoid contamination.replace cap after use.remove contact lenses before using.

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 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 in the affected eye(s).Apply every 3 or 4 hours or as directed by a doctor.

Other Information

  • Retain carton for complete drug factsDo not use if imprinted seal on cap is torn.Store at room temperature 15°-20°C (59°-86°F).Keep cap tightly closed.

Inactive Ingredients

Boric acid, hypromellose, methylparaben, propylene glycol, propylparaben, sodium borate and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.

Questions?

☎ Call (800) 233-5469M-F 8:30AM-5:00PM CST or visitwww.retainebrand.com

* Please review the disclaimer below.