NDC 55319-144 Miconazole Nitrate

Antifungal Miconazorb Af Powder Talc Free

NDC Product Code 55319-144

NDC 55319-144-71

Package Description: 71 g in 1 BOTTLE, PLASTIC

NDC Product Information

Miconazole Nitrate with NDC 55319-144 is a a human over the counter drug product labeled by Family Dollar Services Inc.. The generic name of Miconazole Nitrate is antifungal miconazorb af powder talc free. The product's dosage form is powder and is administered via topical form.

Labeler Name: Family Dollar Services Inc.

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

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.

  • MICONAZOLE NITRATE 1.42 g/71g

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.

  • ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)
  • ALLANTOIN (UNII: 344S277G0Z)
  • IMIDUREA (UNII: M629807ATL)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
  • CHLOROXYLENOL (UNII: 0F32U78V2Q)

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: Family Dollar Services Inc.
Labeler Code: 55319
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: 10-01-2019 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’.

* Please review the disclaimer below.

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 Ingredients

Miconazole nitrate 2%

Purpose

Antifungal

Uses

For the cure of most athlete's foot, jock itch and ringworm

Warnings

For external use only.

Do Not Use

On children under 2 years of age unless directed by a doctor.

When Using This Product

Avoid contact with the eyes

Stop Use And Ask A Doctor If

Irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Clean the affected area & dry thoroughlyapply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctorsupervise children in the use of this productfor athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, & change shoes & socks at least once dailyfor athlete's foot & ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeksif condition persists longer, consult a doctorthis product is not effective on the scalp or nails

Other Information

  • Store between 59º - 86ºFlightly shake bottle to loosen settled powder

Inactive Ingredients

Allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalcium phosphate, zea mays (corn) starch

Questions?

Call 1-866-964-0939

Pincipal Display Panel

  • FAMILY WellnessAntifungalMiconazorb AFPowderMiconazole Nitrate 2%Talc-FreeCures most athlete's foot, jock itch & ringwormRelieves chafing, itching, burning & scalingAbsorbs moistureNet wt 2.5 OZ (71 g)

* Please review the disclaimer below.