Other
Drug Facts
Do not use on children under 2 years of age unless directed by a doctor.
Lotrimin Af Aerosol, Powder
FDA Label NDC 11523-0134
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 Af (NDC 11523-0134). 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
(To Deliver) Miconazole nitrate 2%
Purpose
Antifungal
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
Warnings
For external use only
Otc - Do Not Use
Do not use near heat, flame, or while smoking
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)
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
- 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
Other Information
store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
hydroxypropyl cellulose, isobutane, kaolin, magnesium stearate, SD alcohol 40-B (8% w/w), stearalkonium hectorite, zea mays (corn) starch
Questions?
1-866-360-3266 or visit us at www.lotrimin.com
Distribution
Distributed by: Bayer HealthCare LLC, Whippany NJ
Principal Display Panel - 133 G Can Label
Powder Spray
goes on dry TALC FREE
LOTRIMIN® AF
miconazole nitrate ANTIFUNGAL
Clinically Proven To Cure Most
Athlete's Foot
Relieves
- Itching
- Burning
- Cracking
- Scaling
NET WT 133g (4.6 OZ)
* Please review the disclaimer below.
