Madecassol

Neomycin Sulfate, Titrated Ext. Of Centella Asiatica

I World Pharmaceutical Co., Ltd.
Human Otc Drug
NDC 73442-0004

Madecassol also known as Neomycin Sulfate, Titrated Ext. Of Centella Asiatica is a human otc drug labeled by 'I World Pharmaceutical Co., Ltd.'. National Drug Code (NDC) number for Madecassol is 73442-0004. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Madecassol drug includes Centella Asiatica - 10 mg/g Neomycin Sulfate - 3.5 mg/g . The currest status of Madecassol drug is Active.

Drug Information:

Drug NDC:	73442-0004
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:	Madecassol
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:	Neomycin Sulfate, Titrated Ext. Of Centella Asiatica
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	I World Pharmaceutical Co., Ltd.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Ointment
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:	CENTELLA ASIATICA - 10 mg/g NEOMYCIN SULFATE - 3.5 mg/g
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:	08 Oct, 2019
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, 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:	I World Pharmaceutical Co., Ltd.
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:	7M867G6T1U 057Y626693
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.
Pharmacologic Class:	Aminoglycoside Antibacterial [EPC] Aminoglycosides [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
73442-0004-1	10 g in 1 TUBE (73442-0004-1)	08 Oct, 2019	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

Madecassol

Neomycin Sulfate, Titrated Ext. Of Centella Asiatica

Ointment
I World Pharmaceutical Co., Ltd.
NDC: 73442-0004

Purpose:

â temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, or poison sumac soaps detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, external genital and anal itching

Product Elements:

Madecassol neomycin sulfate, titrated ext. of centella asiatica propylene glycol cetostearyl alcohol petrolatum centella asiatica centella asiatica neomycin sulfate neomycin

Indications and Usage:

â adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily

Warnings:

For external use only. do not use in the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator. ask a doctor before use if you have a vaginal discharge, rectal bleeding, diaper rash. when using this product consult a doctor before exceeding recommended dosage. stop use and ask a doctor if condition gets worse, condition persists for more than 7 days, condition clears up and occurs again with within a few days. do not begin to use any other hydrocortisone product unless you have consulted a doctor. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Dosage and Administration:

For external use only

Package Label Principal Display Panel:

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.