NDC 49035-135 Miconazole Nitrate

Jock Itch Spray

NDC Product Code 49035-135

NDC Product Information

Miconazole Nitrate with NDC 49035-135 is a a human over the counter drug product labeled by Wal-mart Stores, Inc.. The generic name of Miconazole Nitrate is jock itch spray. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Wal-mart Stores, Inc.

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipWhat 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 1.3 g/130g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

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

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Wal-mart Stores, Inc.
Labeler Code: 49035
FDA Application Number: part333C Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-28-2019 Additional informationCallout TooltipWhat 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: 12-31-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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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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

Miconazole nitrate 2%

Purpose

Antifungal

Uses

  • Cures most jock itch (tinea cruris)relieves itching, burning and chafing associated with jock itch

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 120ºF. Intentional misuse by delibrately concentrating and inhaling contents can be harmful or fatal.

When Using This Product

  • Do not get into eyes or mouthuse only as directed.

Stop Use And Ask A Doctor If

  • Irritation occursno improvement within 2 weeks for jock itch

Do Not Use

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

Keep Out Of Reach Of Children.

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

Directions

  • Wash affected area and dry thoroughlyshake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctorsupervise children in the use of this productuse daily for 2 weeks. If conditions persist, consult a doctorthis product is not effective on scalp or nailsif nozzle clogs, clean with a pin

Other Information

Store between 20oC and 30oC (68o and 86oF)

Inactive Ingredient

Disteardimonium Hectorite, Isobutane, Kaolin, SD Alcohol 40-B, Zea Mays (Corn) Starch

Questions?

Call 1-888-287-1915

* Please review the disclaimer below.

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