NDC 36800-071 Miconazole Nitrate

  1. Labeler Index
  2. Topco Associates Llc
  3. NDC: 36800-071 Miconazole Nitrate

NDC Product Code 36800-071

NDC CODE: 36800-071

Proprietary Name: Miconazole Nitrate 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: 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.

NDC Code Structure

NDC 36800-071-16

Package Description: 473 mL in 1 BOTTLE, PLASTIC

NDC 36800-071-25

Package Description: 71 g in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory .

NDC Product Information

Miconazole Nitrate with NDC 36800-071 is a product labeled by Topco Associates Llc. The generic name of Miconazole Nitrate is . The product's dosage form is and is administered via form.

Labeler Name: Topco Associates Llc

Miconazole Nitrate 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.
  • ISOPROPYL ALCOHOL 50 mL/100mL

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.
  • WATER (UNII: 059QF0KO0R)

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.

Labeler Name: Topco Associates Llc
Labeler Code: 36800
Start Marketing Date: 04-01-2016 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: 12-31-2017 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: 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".

* Please review the disclaimer below.

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]

* Please review the disclaimer below.

Miconazole Nitrate Product Label Images

Miconazole Nitrate 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 (By Volume)

Isopropyl alcohol (50% conc.)

Purpose

First aid antiseptic

Uses

  • First aid to help prevent the risk of infection in minor cuts, scrapes and burns

Warnings

  • For external use onlyflammable, keep away from fire or flameif taken internally serious gastric disturbances will result

Ask A Doctor Before Use If You Have

  • Deep or puncture woods, animal bites or serious burns

When Using This Product

  • Do not get into eyesdo not apply over large areas of the bodydo not use longer than one week unless directed by a doctor

Stop Use And Ask A Doctor If

  • Condition persists or gets worse

Keep Out Of Reach Of Children.

In case of ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

  • Clean affected areaapply small amount of this product on the area 1-3 times dailyif bandaged, let dry firstmay be covered with a sterile bandage

Other Information

  • Store at room temperaturedoes not contain, nor is intended as a substitute for grain or ethyl alcohol

Inactive Ingredient

Purified water

Package Label

TopCare 50% Isopropyl Alcohol

* Please review the disclaimer below.