NDC 73442-0004 Madecassol

Neomycin Sulfate, Titrated Ext. Of Centella Asiatica

NDC Product Code 73442-0004

NDC CODE: 73442-0004

Proprietary Name: Madecassol What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Neomycin Sulfate, Titrated Ext. Of Centella Asiatica What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to decrease the risk of infection after certain intestinal surgeries. Neomycin belongs to a class of drugs known as aminoglycoside antibiotics. It works by stopping the growth of bacteria in the intestines. Neomycin may also be used along with a special diet to treat a certain serious brain problem (hepatic encephalopathy). This condition is caused by too much of a certain natural substance (ammonia). Normally, the liver gets rid of ammonia, but liver disease can cause too much ammonia to build up in the body. This medication helps treat encephalopathy by killing certain intestinal bacteria that make ammonia. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

NDC Code Structure

  • 73442 - I World Pharmaceutical Co., Ltd.

NDC 73442-0004-1

Package Description: 10 g in 1 TUBE

NDC Product Information

Madecassol with NDC 73442-0004 is a a human over the counter drug product labeled by I World Pharmaceutical Co., Ltd.. The generic name of Madecassol is neomycin sulfate, titrated ext. of centella asiatica. The product's dosage form is ointment and is administered via topical form.

Labeler Name: I World Pharmaceutical Co., Ltd.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Madecassol Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CENTELLA ASIATICA 10 mg/g
  • NEOMYCIN SULFATE 3.5 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • PETROLATUM (UNII: 4T6H12BN9U)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: I World Pharmaceutical Co., Ltd.
Labeler Code: 73442
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 10-08-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Madecassol Product Label Images

Madecassol Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Neomycin Sulfate, Titrated Ext. of Centella Asiatica

Otc - Purpose

■ 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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

■ 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.

Inactive Ingredient

Cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, white petrolatum

Dosage & Administration

For external use only

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