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Lotrimin antifungal - Medication Information

Product NDC Code 11523-0544
Drug Name

Lotrimin antifungal

Type Brand
Pharm Class Azole Antifungal [EPC],
Azoles [CS]
Active Ingredients
Miconazole nitrate 20 mg/g
Route TOPICAL
Dosage Form AEROSOL, POWDER
RxCUI drug identifier 998428
Application Number part333C
Labeler Name Bayer Healthcare LLC.
Packages
Package NDC Code Description
11523-0544-2 133 g in 1 can (11523-0544-2)
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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) 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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients isobutane, SD alcohol 40-B (8% v/v), stearalkonium hectorite, talc

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 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

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.
Lotrimin Antifungal Miconazole nitrate ISOBUTANE TALC MICONAZOLE NITRATE MICONAZOLE 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.
PRINCIPAL DISPLAY PANEL - 133 g Can Label Powder Spray goes on dry NDC 11523-0544-2 LOTRIMIN ® AF ANTIFUNGAL miconazole nitrate Clinically Proven To Cure Most Athlete's Foot Relieves Itching, Burning, Cracking & Scaling NET WT 133g (4.6 OZ) Label

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 Distribution Distributed by: Bayer HealthCare LLC, Whippany NJ

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.
Flammable: Do not use while smoking or near heat or flame

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-866-360-3266

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 there is no improvement within 4 weeks (for athlete's foot and ringworm) or 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 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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store between 20° to 25°C (68° to 77°F)

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 Flammable: Do not use while smoking or near heat or flame Do not use on children under 2 years of age except under the advice and supervision of 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. 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.

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