NDC 77015-420 Soldamist Dn-420

Benzalkonium Chloride

NDC Product Code 77015-420

NDC 77015-420-13

Package Description: 75 mL in 1 BOTTLE

NDC Product Information

Soldamist Dn-420 with NDC 77015-420 is a a human over the counter drug product labeled by 3vets Llc. The generic name of Soldamist Dn-420 is benzalkonium chloride. The product's dosage form is spray and is administered via topical form.

Labeler Name: 3vets Llc

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Soldamist Dn-420 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.

  • BENZALKONIUM CHLORIDE .13 g/100mL

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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • THYME OIL (UNII: 2UK410MY6B)
  • WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)

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: 3vets Llc
Labeler Code: 77015
FDA Application Number: part333A 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: 01-20-2021 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 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’.

* Please review the disclaimer below.

Soldamist Dn-420 Product Label Images

Soldamist Dn-420 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%

Purpose

ANTIMICROBIAL

Uses

Sanitizes to kills germs and helps reduce bacteria.

Warnings

For external use only.Avoid usage if allergic to any of the ingredients.Stop using and consult a doctor if redness or irritation develops and persists for more than 72 hours.

Otc - Keep Out Of Reach Of Children

Keep away from children. In case of accidental ingestion, seek medical help or contact a poison control center immediately (1-800-222-1222).

Directions

Spray sufficient amount of solution and allow to dry without wiping.

Inactive Ingredients

Water, Glycerine, Propylene Glycol, Rosemary Oil, Thyme Oil, Lemon Grass Oil.

* Please review the disclaimer below.