Azzurx

Melissa Officinalis Leaf,thuja Occidentalis Leaf,geranium Maculatum,calendula Officinalls

Outbreaks, Inc.
Human Otc Drug
NDC 83243-001

Azzurx also known as Melissa Officinalis Leaf,thuja Occidentalis Leaf,geranium Maculatum,calendula Officinalls is a human otc drug labeled by 'Outbreaks, Inc.'. National Drug Code (NDC) number for Azzurx is 83243-001. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Azzurx drug includes Calendula Officinalis Flower - 3 [hp_X]/.5mL Geranium Maculatum Root - 3 [hp_X]/.5mL Melissa Officinalis Leaf - 3 [hp_X]/.5mL Thuja Occidentalis Leaf - 3 [hp_X]/.5mL . The currest status of Azzurx drug is Active.

Drug Information:

Drug NDC:	83243-001
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:	Azzurx
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:	Melissa Officinalis Leaf,thuja Occidentalis Leaf,geranium Maculatum,calendula Officinalls
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Outbreaks, 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:	CALENDULA OFFICINALIS FLOWER - 3 [hp_X]/.5mL GERANIUM MACULATUM ROOT - 3 [hp_X]/.5mL MELISSA OFFICINALIS LEAF - 3 [hp_X]/.5mL THUJA OCCIDENTALIS LEAF - 3 [hp_X]/.5mL
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 HOMEOPATHIC
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:	13 Feb, 2023
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	22 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, 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:	Outbreaks, 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:	P0M7O4Y7YD 93IXI5B6OJ 50D2ZE9219 0T0DQN8786
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
83243-001-01	3 APPLICATOR in 1 PACKAGE (83243-001-01) / .5 mL in 1 APPLICATOR	13 Feb, 2023	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.

Other medicines with the same generic name

Azzurx

Melissa Officinalis Leaf & more..

Liquid
Outbreaks, Inc.
NDC: 83243-001

Purpose:

Product Elements:

Azzurx melissa officinalis leaf,thuja occidentalis leaf,geranium maculatum,calendula officinalls medium-chain triglycerides chamomile flower oil lavender oil eucalyptus oil peppermint oil melissa officinalis leaf melissa officinalis leaf thuja occidentalis leaf thuja occidentalis leaf geranium maculatum root geranium maculatum root calendula officinalis flower calendula officinalis flower

Indications and Usage:

Uses for treatment of cold sores and fever blisters.

Warnings:

Warnings for external use only. flammable, keep away from fire or flame. do not use if you are allergic to any ingredient in this product over large areas of the body when using this product apply only to affected area do not use in or near eyes avoid applying directly inside the mouth you may feel a brief burning sensation when you apply it. it should go away in a short time. do not share or reuse an applicator, as spreading or reinfection may occur. do not remove cardboard sleeve after crushing,as cuts from glass may occur. stop use and ask a doctor if â the cold sore worsens or the cold sore lasts for more than 7 days, or condition clears up and occurs again within a few days ask a doctor if â you are pregnant or nursing keep out of reach of children . if swallowed, get medical help or contact a poison control center.

Dosage and Administration:

Directions application instructions remove and reverse cardboard sleeve on applicator to expose swab. crush applicator to activate by squeezing on the âxâ (in azzurx) between thumb and forefinger until you hear a snap. rotate applicator with swab pointing downward and squeeze gently until the swab is saturated. discard after use. at the first sign of cold sore/fever blister (tingle) : clean the area of the tingle before applying. apply directly to face or lips at the site of the tingle. repeat every 12 hours until all applicators are used. after cold sore/fever blister erupts (skin broken): clean the area of the outbreak before applying. apply directly to the affected area of the face or lips. repeat every 24 hours as needed children under 12: ask a doctor

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Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.