NDC 21130-341 Signature Care Athletes Foot

Miconazole Nitrate

NDC Product Code 21130-341

NDC CODE: 21130-341

Proprietary Name: Signature Care Athletes Foot 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.

Product Characteristics

Color(s):
WHITE (C48325 - TO OFF WHITE)

NDC Code Structure

  • 21130 - Safeway

NDC 21130-341-90

Package Description: 130 g in 1 CAN

NDC Product Information

Signature Care Athletes Foot with NDC 21130-341 is a a human over the counter drug product labeled by Safeway. The generic name of Signature Care Athletes Foot is miconazole nitrate. The product's dosage form is spray and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 998533.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Signature Care Athletes Foot 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.


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.

  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • ISOBUTANE (UNII: BXR49TP611)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • TALC (UNII: 7SEV7J4R1U)
  • ALCOHOL (UNII: 3K9958V90M)
  • STEARALKONIUM HECTORITE (UNII: OLX698AH5P)

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: Safeway
Labeler Code: 21130
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: 10-09-2015 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: 12-31-2021 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 - NO 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".

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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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Signature Care Athletes Foot Product Label Images

Signature Care Athletes Foot 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

  • •proven clinically effective in the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) •for effective relief of itching, cracking, burning, scaling and discomfort

Warnings

For external use onlyFlammable: Do not use while smoking or near heat or flame

Do Not Use

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

When Using This Product

  • •avoid contact with the eyes •use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. •contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F (49°C).

Stop Use And Ask A Doctor If

  • •irritation occurs •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 (1-800-222-1222).

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 •for athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks •if condition persists longer, ask a doctor •this product is not effective on the scalp or nails •in case of clogging, clean nozzle with a pin

Other Information

  • •store at 20-25°C (68-77°F)

Inactive Ingredients

Alcohol denat., aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propylene carbonate, sorbitan monooleate, stearalkonium hectorite, talc

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