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Miconazole nitrate - Medication Information

Product NDC Code 70403-924
Drug Name

Miconazole nitrate

Type Generic
Pharm Class Azole Antifungal [EPC],
Azoles [CS]
Active Ingredients
Miconazole nitrate 20 mg/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 998483
Application Number part333C
Labeler Name Aru Pharma Inc.
Packages
Package NDC Code Description
70403-924-30 1 tube in 1 carton (70403-924-30) / 30 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Miconazole Nitrate USP 2%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor 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 not effective on the scalp or nails

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Cetostearyl alcohol, Cetomacrogol 1000, Paraffin wax, Micro crystalline wax, Light liquid paraffin, Polyethylene Glycol, Chlorocresol and purified water

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) for effective relief of itching, scaling, cracking, burning and discomfort that can accompany these conditions.

Purpose

Information about the drug product’s indications for use.
Purpose Antifungal

Spl product data elements

Usually a list of ingredients in a drug product.
Miconazole Nitrate Miconazole Nitrate MICONAZOLE NITRATE MICONAZOLE CETOSTEARYL ALCOHOL CETETH-20 PARAFFIN MICROCRYSTALLINE WAX LIGHT MINERAL OIL POLYETHYLENE GLYCOL, UNSPECIFIED CHLOROCRESOL WATER white to off white

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Packaging Micnzle1

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts CURES MOST ATHLETE'S FOOT Relieves Itching and Burning Sensation Relieves from Cracking and scaling. Grease less and non-staining Compared to the active ingredient in Micatin Distributed by. ARU PHARMA INC. MOUNT VERNON, NY 10552 www.qpackrx.com

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? 1 844 500-2729‬ between 9 am and 4 pm EST, Monday to Friday.

Storage and handling

Information about safe storage and handling of the drug product.
Other information • Do not use if seal is damaged or is not visible. • To open, unscrew cap, pull tab to remove foil seal • store at room temperature not exceeding 30 ​° ​C (86 ​° ​F). Do not freeze. • see carton or tube crimp for lot number and expiration date

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only Do not use on children less than 2 years of age unless directed by a doctor When using this product avoid contact with eyes Stop use and ask a doctor if • irritation occurs • condition persist • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API