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Drug Facts
Lotrimin Aerosol, Powder
FDA Label NDC 11523-0136
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 11523-0136). 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, otc - active ingredient, otc - purpose, use, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient
(To Deliver)Tolnaftate 1%
Otc - Purpose
Purpose
Antifungal
Use
Use
clinically proven to prevent most athlete’s foot with daily use
Warnings
Warnings
For external use only
Flammable: Do not use near heat, flame, or while smoking
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 contents can be harmful or fatal.
- contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F.
Otc - Stop Use
Stop use and ask a doctor if irritation occurs.
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
Directions
- to prevent athlete’s foot, wash the feet and dry thoroughly.
- shake can well and spray a thin layer of the product on the feet once or twice daily (morning and/or night).
- supervise children in the use of this product.
- pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
Other Information
Other Information
store between 20° to 25°C (68°– 77°F)
Inactive Ingredient
Inactive Ingredients
butylated hydroxytoluene, fragrance, hydroxypropyl cellulose, isobutane, kaolin, magnesium stearate, PPG-12-Buteth-16, SD alcohol 40B (9% w/w), zea mays (corn) starch
Otc - Questions
Questions?1-866-360-3266 or visit us at www.lotrimin.com
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