FDA Label for Lotrimin Af Antifungal
View Indications, Usage & Precautions
Lotrimin Af Antifungal Product Label
The following document was submitted to the FDA by the labeler of this product Bayer Healthcare Llc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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
Flammable
Do not use while smoking or near heat or flame
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor
Otc - When Using
When using this product
- avoid contact with the eyes
- use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal
- Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
Otc - Stop Use
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
dimethyl ether, polyoxyl 15 hydroxystearate, sd alcohol 40-B (16.5% v/v)
Questions?
1-866-360-3266
Distribution
Distributed by Bayer HealthCare LLC
Whippany, NJ 07981 USA
Principal Display Panel - 133 G Can Label
Liquid Spray
cools the burn
NDC 11523-4327-01
LOTRIMIN®AF
ANTIFUNGAL
miconazole nitrate
Clinically Proven To Cure
Most Athlete's Foot
- Relieves Itching,
Burning, Cracking
& Scaling
NET WT 133g (4.6 OZ)
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