NDC 44577-205 Macerrx Web

Miconazole Nitrate

NDC Product Code 44577-205

NDC CODE: 44577-205

Proprietary Name: Macerrx Web 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: Miconazole Nitrate 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 treat vaginal yeast infections. Miconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection. The vaginal product comes in 2 forms (a vaginal cream or tablet). Some products also come with a skin cream to be applied to the area around the outside of the vagina. Ask your doctor before using this medication for self-treatment if this is your first vaginal infection. This medication only works for vaginal fungal infections. You may have a different type of infection (such as bacterial vaginosis) and may need a different medication. If you have fever, chills, flu-like symptoms, stomach/abdominal pain, or a bad-smelling vaginal discharge, do not use this medication. Contact your doctor right away because these may be signs of a more serious infection.

NDC Code Structure

  • 44577 - Clinical Therapeutic Solutions

NDC 44577-205-56

Package Description: 1 TUBE in 1 CARTON > 56 g in 1 TUBE

NDC Product Information

Macerrx Web with NDC 44577-205 is a a human over the counter drug product labeled by Clinical Therapeutic Solutions. The generic name of Macerrx Web is miconazole nitrate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Clinical Therapeutic Solutions

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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.

Macerrx Web 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.

  • MICONAZOLE NITRATE 2 g/100g

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.

  • ACETIC ACID (UNII: Q40Q9N063P)
  • WATER (UNII: 059QF0KO0R)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Clinical Therapeutic Solutions
Labeler Code: 44577
FDA Application Number: part333C What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 06-06-2013 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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Information for Patients

Miconazole

Miconazole is pronounced as (mi kon' a zole)

Why is miconazole medication prescribed?
Miconazole, an antifungal agent, is used for skin infections such as athlete's foot and jock itch and for vaginal yeast infections.This medication is sometimes prescribed...
[Read More]

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Macerrx Web Product Label Images

Macerrx Web 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

Active Ingredient:

-Miconazole Nitrate 2.00%

Purpose

Antifungal

Uses:

  • Proven clinically to cure most:athlete’s foot (tinea pedis)ringworm (tinea corporis) Effectively soothese and relieves:itchingburningcrackingHelps prevent most athlete’s foot from coming back with daily useFor the treatment of superficial skin infections caused by yeast (Candida albicans, intertrigo) and erythrasma

Warnings:

  • For external use only

When Using This Product:

  • Avoid contact with eyes

Stop Use And Ask A Doctor If:

  • Irritation occursThere is no improvement within 4 weeks

Keep Out Of Reach Of Children.

If swallowed, contact physician or poison control center immediately.

Store At Room

Temperature 68-77ºF (20-25º C)

Directions:

  • Clean the affected area and dry thoroughlyapply a thin layer over the affected area twice daily (morning and night)supervise children in the use of this productfor athlete’s foot, pay special attention to the spaces between toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once dailyuse daily for 4 weeks. If condition lasts longer, ask a doctorto prevent athlete’s foot, apply to the feet once or twice dailythis product is not effective on the scalp or nails

Other Ingredients:

Acetic Acid, Aqua (Deionized Water), Carbomer, Ethylhexylglycerin, Hydroxyethylcellulose, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, SD-Alcohol, Triethanolamine

Macerrxtm Web Gel

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