NDC 81900-013 Nasoclenz

Benzalkonium Chloride 0.13%

NDC Product Code 81900-013

NDC 81900-013-01

Package Description: 40 POUCH in 1 BOX > 1 POUCH in 1 POUCH > 1 mL in 1 POUCH

NDC 81900-013-02

Package Description: 8 POUCH in 1 BOX > 1 POUCH in 1 POUCH > 1 mL in 1 POUCH

NDC Product Information

Nasoclenz with NDC 81900-013 is a a human over the counter drug product labeled by Silicon Valley Innovations, Inc.. The generic name of Nasoclenz is benzalkonium chloride 0.13%. The product's dosage form is gel and is administered via topical form.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Nasoclenz 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.

  • DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
  • WATER (UNII: 059QF0KO0R)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Silicon Valley Innovations, Inc.
Labeler Code: 81900
FDA Application Number: part333E 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 11-01-2021 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: 12-31-2022 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".

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Nasoclenz Product Label Images

Nasoclenz 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

Benzalkonium chloride (0.13%)

Uses

  • Helps reduce bacteria that can cause skin infections

Indications & Usage

  • Antiseptic preparation to decrease bacteria on skin

Warnings

For external use only.

Do Not Use

  • If you are allegic to any of the ingredientsIn or near eyesOn children under 2 years of age

Ask A Doctor Before Use If You Have

  • Deep or puncture woundsSerious burns

Stop Use And Ask A Doctor If

  • Irritation, swelling, pain or other allergic reaction developsInfection occurs

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Open gel packets and apply gel to tip of applicatorInsert tip with gel into the right nostril, rotating it a few times, then rotate it in the opposite direction.Using a second applicator, apply gel to tip and repeat step #2 in the left nostrilDo not blow nose immediately after use.

Dosage & Administration

  • Use every 4-8 hours as neededChildren under age 12 use adult supervision

Other Information

Best if stored at 59-84F (19-29C)

Inactive Ingredients

Carbomer, Diethylene Glycol Monoethyl Ether, Glycerin, Propylene Glycol, Triethanolamine, Water

Questions?

Call 1-844-4MY-NASO (1-844-469-6276) M-F 9am to 5pm PSTNasoclenz.com

* Please review the disclaimer below.