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| Product NDC Code | 11523-4140 | ||||
|---|---|---|---|---|---|
| Drug Name | Lotrimin antifungal |
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| Type | Brand | ||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | AEROSOL, POWDER | ||||
| RxCUI drug identifier | 998428 | ||||
| Application Number | part333C | ||||
| Labeler Name | Bayer Healthcare LLC. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 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 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 jock itch (tinea cruris) for effective relief of itching, burning, scaling and discomfort, and chafing associated with jock itch
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 TALC MICONAZOLE NITRATE MICONAZOLE ISOBUTANE 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 11523-4140-2 LOTRIMIN ® AF ANTIFUNGAL miconazole nitrate Clinically Proven To Cure Most Jock Itch Relieves Itching, Burning, Scaling & Chafing NET WT 133g (4.6 OZ) Label 133 g
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 07981 USA
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 except under the advice and supervision of 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.
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 2 weeks
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 2 weeks 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