Avoca Flexible Caustic Applicator
Silver Nitrate Applicator
Bray Group Limited
Human Prescription Drug
NDC 65875-101Avoca Flexible Caustic Applicator also known as Silver Nitrate Applicator is a human prescription drug labeled by 'Bray Group Limited'. National Drug Code (NDC) number for Avoca Flexible Caustic Applicator is 65875-101. This drug is available in dosage form of Stick. The names of the active, medicinal ingredients in Avoca Flexible Caustic Applicator drug includes Silver Nitrate - 30 mg/40mg . The currest status of Avoca Flexible Caustic Applicator drug is Active.
Drug Information:
| Drug NDC: | 65875-101 |
| 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: | Avoca Flexible Caustic Applicator |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription 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: | Silver Nitrate Applicator |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bray Group Limited |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Stick |
| 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: | SILVER NITRATE - 30 mg/40mg
|
| 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: | UNAPPROVED DRUG OTHER |
| 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 Apr, 1925 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 27 Dec, 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. |
| 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: | Bray Group Limited
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1117536
2049636
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0365875101093
|
| UPC stands for Universal Product Code. |
| UNII: | 95IT3W8JZE
|
| 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 |
|---|
| 65875-101-09 | 10 VIAL in 1 BOX (65875-101-09) / 4000 mg in 1 VIAL | 01 Apr, 1925 | 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. |
Product Elements:
Avoca flexible caustic applicator silver nitrate applicator potassium nitrate silver nitrate silver cation
Indications and Usage:
Uses caustic applicators are useful for cauterization of skin or mucous membrane and for the removal of granulation tissue, warts and verrucae.
Warnings and Cautions:
Caution keep out of reach of children. do not use on or near eyes.
Dosage and Administration:
Dosage & administration prior to use, the applicator stick may be bent or shaped to allow easier access to the target area. the medicated end of the applicator should be moistened in clean water and applied to the affected tissue. one applicator is normally sufficient for each application. the strength of the action is controlled by the amount of water used to moisten the tip. the applicator action can be stopped by washing the area with a saline solution (0.9% sodium chloride).
Contraindications:
Contraindications & antidotes caustic applicators must not be used for genital warts. continued application to mucous membranes and open wounds leads to argyria, a bluish-black discoloration of the skin due to depositions of granules of silver compounds in the connective tissues. this condition persists indefinitely or disappears very slowly. poisoning by oral ingestion is unlikely with the quantities involved, but treatment for poisoning is the immediate ingestion of large amounts of salt water followed by an emetic. then administer a dose of epsom salts followed with milk. immediately call a physician.
Package Label Principal Display Panel:
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