New Skin Bandage
Benzethonium Chloride
Advantice Health, Llc
Human Otc Drug
NDC 16864-440New Skin Bandage also known as Benzethonium Chloride is a human otc drug labeled by 'Advantice Health, Llc'. National Drug Code (NDC) number for New Skin Bandage is 16864-440. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in New Skin Bandage drug includes Benzethonium Chloride - 1.8 mg/mL . The currest status of New Skin Bandage drug is Active.
Drug Information:
| Drug NDC: | 16864-440 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | New Skin Bandage |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Benzethonium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Advantice Health, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | BENZETHONIUM CHLORIDE - 1.8 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Mar, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part333A |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Advantice Health, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0851409007011
|
| UPC stands for Universal Product Code. |
| UNII: | PH41D05744
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 16864-440-01 | 1 BOTTLE, WITH APPLICATOR in 1 BOX (16864-440-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR | 01 Mar, 2011 | N/A | No |
| 16864-440-02 | 1 BOTTLE, WITH APPLICATOR in 1 BOX (16864-440-02) / 10 mL in 1 BOTTLE, WITH APPLICATOR | 01 Mar, 2011 | N/A | No |
| 16864-440-03 | 1 BOTTLE, WITH APPLICATOR in 1 BOX (16864-440-03) / 13 mL in 1 BOTTLE, WITH APPLICATOR | 01 Mar, 2011 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose first aid antiseptic
Product Elements:
New skin bandage benzethonium chloride benzethonium chloride benzethonium ethyl acetate acetone butyl acetate amyl acetate alcohol pyroxylin camphor (natural)
Indications and Usage:
Use first aid to help prevent bacterial contamination in minor cuts and scrapes
Warnings:
Warnings for external use only flammable keep away from fire or flame do not use in the eyes over large areas of the body longer than one week unless directed by a doctor on infected areas or wounds that are draining with other first aid products such as lotions and creams over sutures on mucous membranes ask a doctor before use if you have deep or puncture wounds deep cuts animal bites serious bleeding diabetes poor circulation serious burns when using this product do not store at temperatures above 120°f intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal stop use and ask a doctor if condition persists or gets worse infection occurs keep out of reach of children. if swallowed, get medical help or call a poison control center right away.
Do Not Use:
Warnings for external use only flammable keep away from fire or flame do not use in the eyes over large areas of the body longer than one week unless directed by a doctor on infected areas or wounds that are draining with other first aid products such as lotions and creams over sutures on mucous membranes ask a doctor before use if you have deep or puncture wounds deep cuts animal bites serious bleeding diabetes poor circulation serious burns when using this product do not store at temperatures above 120°f intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal stop use and ask a doctor if condition persists or gets worse infection occurs keep out of reach of children. if swallowed, get medical help or call a poison control center right away.
When Using:
When using this product do not store at temperatures above 120°f intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal
Dosage and Administration:
Directions clean affected area apply small amount on the area 13 times daily let dry a second coating may be applied for extra protection to remove, apply more new-skin ® liquid bandage and quickly wipe off
Stop Use:
Stop use and ask a doctor if condition persists or gets worse infection occurs
Package Label Principal Display Panel:
Principal display panel - 30 ml bottle box new- skin ® benzethonium chloride 0.2%/first aid antiseptic liquid bandage brush all-in-one protection prevents infection seals out water, dirt & germs helps heal cuts #1 pharmacist recommended works where bandages can't 1.0 fl oz (30 ml) principal display panel - 30 ml bottle box
Further Questions:
Questions? 1-800-345-0032