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Drug Facts
Lotrimin Aerosol, Powder
FDA Label NDC 11523-0133
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Lotrimin (NDC 11523-0133). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Miconazole nitrate 2%
Purpose
Antifungal
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
Warnings
For external use only
Flammable: Do not use while smoking or near heat or flame
Otc - Do Not Use
For external use only
Flammable: DO not use near heat, flame, or while smoking
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.
Stop Use And Ask A Doctor If
- irritation occurs
- there is no improvement within 2 weeks
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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
Other Information
store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
hydroxypropyl cellulose, isobutane, kaolin, magnseium stearate, SD alcohol 40-B (8% v/v), stearalkonium hectorite, zea mays (corn) starch
Questions?
1-866-360-3266
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)
* Please review the disclaimer below.
