NDC 41250-196 Miconazole Nitrate
Athletes Foot Powder Spray Talc Free Aerosol, Powder Topical

Product Information

Product Code41250-196
Proprietary Name 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.
Miconazole Nitrate
Non-Proprietary Name 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.
Athletes Foot Powder Spray Talc Free
Product Type 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.
Human Otc Drug
Dosage FormAerosol, Powder - A product that is packaged under pressure and contains therapeutically active ingredients, in the form of a powder, that are released upon activation of an appropriate valve system.
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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Meijer Distribution Inc
Labeler Code41250
FDA Application Number 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.
part333C
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-04-2018
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Packages

NDC 41250-196-46

Package Description: 130 g in 1 CAN

Product Details

Miconazole Nitrate is a human over the counter drug product labeled by Meijer Distribution Inc. The generic name of Miconazole Nitrate is athletes foot powder spray talc free. The product's dosage form is aerosol, powder and is administered via topical form.


What are Miconazole Nitrate Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.

  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • ISOBUTANE (UNII: BXR49TP611)
  • KAOLIN (UNII: 24H4NWX5CO)
  • ALCOHOL (UNII: 3K9958V90M)
  • ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


* Please review the disclaimer below.

Patient Education

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]

* Please review the disclaimer below.

Miconazole Nitrate Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient



Miconazole nitrate 2%


Purpose



Antifungal


Uses



  • cures most athlete's foot (linea pedis), ringworm (linea corporis) and jock itch (linea cruris)
  • relieves symptoms of athlete's foot, including itching burning and cracking

Warnings



For external use only.


Flammable:



Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F


When Using This Product



  • do not get into eyes or mouth
  • use only as directed
  • Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.


Stop Use And Ask A Doctor If



  • irritation occurs
  • no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.


Directions



  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch, if conditions persist, consult a doctor
  • this product is not effective on the scalp or nails
  • in case clogging, clear nozzle under running water

Other Information



store between 20° and 30°C (68°F and 86°)


Inactive Ingredients



SD alcohol 40-B(10%w/w), isobutane (propellant), stearalkonium hectorite, talc


Questions?



call 1-866-964-0939


Principal Display Panel



meijer

Antifungal 

Athlete's Foot

Powder Spray

Miconazole Nitrate 2%

Talc- free

  • Cures most athlete's foot
  • Relieves itching, burning, scaling & cracking
  • NET WT 4.6 OZ (130g)


* Please review the disclaimer below.