MedPath

Avoca Flexible Caustic Applicator

Approved
Approval ID

b7e75a9c-d7d1-4cb9-b09e-26597d73f1ff

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 19, 2021

Manufacturers
FDA

Bray Group Limited

DUNS: 217504463

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Silver Nitrate Applicator

PRODUCT DETAILS

NDC Product Code65875-101
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateJuly 18, 2018
Generic NameSilver Nitrate Applicator

INGREDIENTS (2)

POTASSIUM NITRATEInactive
Quantity: 10 mg in 40 mg
Code: RU45X2JN0Z
Classification: IACT
SILVER NITRATEActive
Quantity: 30 mg in 40 mg
Code: 95IT3W8JZE
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/19/2021

Image of label02:Flexible Caustic Applicator 6”

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/18/2018

Uses

Caustic applicators are useful for cauterization of skin or mucous membrane and for the removal of granulation tissue, warts and verrucae.

CONTRAINDICATIONS SECTION

LOINC: 34070-3Updated: 7/18/2018

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.

WARNINGS AND PRECAUTIONS SECTION

LOINC: 43685-7Updated: 7/18/2018

Caution

KEEP OUT OF REACH OF CHILDREN. DO NOT USE ON OR NEAR EYES.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 1/19/2021

Storage

Store at room temperature in the closed package, in a dry place protected from light. Exposure to light will cause the silver nitrate tip to turn black, but will not affect the product's potency. Not made with natural rubber latex.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/18/2018

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).

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Avoca Flexible Caustic Applicator - FDA Drug Approval Details