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Miconazole nitrate - Medication Information

Product NDC Code 11822-0135
Drug Name

Miconazole nitrate

Type Brand
Pharm Class Azole Antifungal [EPC],
Azoles [CS]
Active Ingredients
Miconazole nitrate 2.6 g/130g
Route TOPICAL
Dosage Form AEROSOL, POWDER
RxCUI drug identifier 998428
Application Number M005
Labeler Name Rite Aid Corporation
Packages
Package NDC Code Description
11822-0135-4 130 g in 1 can (11822-0135-4)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Miconazole nitrate 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 wash affected area and dry thoroughly shake can well and spray a thin layer 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 use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch, if conditions persists, consult a doctor this product is not effective on the scalp or nails if nozzle clogs, clean with a pin

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients disteardimonium hectorite, isobutane, kaolin, SD alcohol 40-B, zea mays (corn) starch

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 cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris) relieves symptoms of athlete's foot, including itching, burning and cracking

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 Athletes Foot Powder Spray Talc Free DISTEARDIMONIUM HECTORITE ISOBUTANE KAOLIN ALCOHOL ZEA MAYS SUBSP. MAYS WHOLE MICONAZOLE NITRATE MICONAZOLE

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.
Principal Display Panel Rite Aid Pharmacy Antifungal Athlete's Foot Powder Spray Miconazole Nitrate 2% cures most athlete's foot relieves itching, cracking & burning talc-free NET WT 4.6 OZ (130g) powder spray

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on children under 2 years of age unless directed by a doctor.

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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information store between 20º and 30ºC (68ºF and 86º)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? call 1-866-964-0939

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if irritation occurs no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product avoid contact with the eyes or mouth use only as directed

Safe handling warning

Safe Handling Warning
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 deliberately concentrating and inhaling contents can be harmul or fatal.

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.
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 deliberately concentrating and inhaling contents can be harmul or fatal. When using this product avoid contact with the eyes or mouth use only as directed Stop use and ask a doctor if irritation occurs no improvement within 4 weeks for athlete's foot and ringworm; 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.

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