Premier Solutions Liquid Bandage
Benzethonium Chloride Dyclonine Hydrochloride
Premier Brands Of America, Inc.
Human Otc Drug
NDC 56104-246Premier Solutions Liquid Bandage also known as Benzethonium Chloride Dyclonine Hydrochloride is a human otc drug labeled by 'Premier Brands Of America, Inc.'. National Drug Code (NDC) number for Premier Solutions Liquid Bandage is 56104-246. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Premier Solutions Liquid Bandage drug includes Benzethonium Chloride - .2 mg/10mL Dyclonine Hydrochloride - .75 mg/10mL . The currest status of Premier Solutions Liquid Bandage drug is Active.
Drug Information:
| Drug NDC: | 56104-246 |
| 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: | Premier Solutions Liquid 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 Dyclonine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Premier Brands Of America, Inc. |
| 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 - .2 mg/10mL
DYCLONINE HYDROCHLORIDE - .75 mg/10mL
|
| 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: | 16 Jun, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 May, 2026 |
| 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, 2024 |
| 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: | Premier Brands of America, Inc.
|
| 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. |
| UNII: | PH41D05744
ZEC193879Q
|
| 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 |
|---|
| 56104-246-01 | 10 mL in 1 BOTTLE, WITH APPLICATOR (56104-246-01) | 16 Jun, 2022 | 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 topical analgesic
Product Elements:
Premier solutions liquid bandage benzethonium chloride dyclonine hydrochloride acetone amyl acetate castor oil ethyl acetate pyroxylin alcohol benzethonium chloride benzethonium dyclonine hydrochloride dyclonine
Indications and Usage:
Uses first aid to prevent bacteria contamination in minor cuts and scrapes
Warnings:
Warnings for external use only. flammable: do not use while smoking or near heat or flame. do not use in the eyes over large areas of the body longer than 1 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 puncture wounds deep cuts animal bites serious burns when using this product avoid contact with eyes stop use and ask a doctor if conditions persists or gets worse infection occurs symptoms persist for more than 7 days or clear up and occue again within a few days 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: do not use while smoking or near heat or flame. do not use in the eyes over large areas of the body longer than 1 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 puncture wounds deep cuts animal bites serious burns when using this product avoid contact with eyes stop use and ask a doctor if conditions persists or gets worse infection occurs symptoms persist for more than 7 days or clear up and occue again within a few days 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 avoid contact with eyes
Dosage and Administration:
Directions for adults and children 2 years of age and older clean affected area apply a small amount on the area 1-3 times daily let dry a second coating may be applied for extra protection children under 2 years of age: consult a doctor
Stop Use:
Stop use and ask a doctor if conditions persists or gets worse infection occurs symptoms persist for more than 7 days or clear up and occue again within a few days
Package Label Principal Display Panel:
Principal display panel antiseptic liquid bandage helps prevent infection for small cuts and wounds invisible, flexible, waterproof, easy to use net wt 0.3 fl oz (9 ml) image 1 image 2
Further Questions:
Questions call 1-866-964-0939