Tolnaftate 1.13 g/113g
Foot Odor Control Spray · AEROSOL, SPRAY · Topco Associates LLC
Tolnaftate is an over-the-counter spray applied directly to the skin to help control foot odor. It comes as an aerosol spray that you can purchase without a prescription.
Key Facts
- Brand Name
- Tolnaftate
- Generic Name
- Foot Odor Control Spray
- NDC Code (Product)
36800-023- Manufacturer
- Topco Associates LLC
- Strength
- 1.13 g/113g
- Dosage Form
- AEROSOL, SPRAY
- Route
- TOPICAL
- Marketing Status
- Application #
- M005
- Marketing Start
- 01/05/2012
Recall History
Bayer Healthcare Pharmaceuticals Inc.
Chemical Contamination: presence of benzene
Bayer Healthcare Pharmaceuticals Inc.
Chemical Contamination: presence of benzene
Bayer Healthcare Pharmaceuticals Inc.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Bayer Healthcare Pharmaceuticals Inc.
Chemical Contamination: presence of benzene
Bayer Healthcare Pharmaceuticals Inc.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Bayer Healthcare Pharmaceuticals Inc.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Bayer Healthcare Pharmaceuticals Inc.
Chemical Contamination: presence of benzene
Bayer Healthcare Pharmaceuticals Inc.
cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
Ecometics, Inc.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Bayer Healthcare Pharmaceuticals Inc.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) prevent recurrence of most athlete's foot with daily use for effective relief of itching, cracking and burning
Dosage & Administration
Directions wash affected area and dry thoroughly shake can well and spray a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor 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 if condition persists, consult a doctor to prevent athlete's foot: wash the feet and dry thoroughly; spray a thin layer of the product to the feet once or twice daily (morning and/or night) this product is not effective on the scalp or nails if nozzle clogs, clean with a pin
Warnings
Warnings For external use only. Flammable: Contents under pressue. Avoid spraying in eyes. Do not use or store near heat or open flame. Do not puncture or incinerate container. Do not store at temperature above 120F. Keep out of reach of children. Use only as directed. Intentional misuse by dilberately concentrating and inhaling the contents can be harmful or fatal. When using this product avoid contact with the eyes or mouth use only as directed Stop use and ask a doctor if irritation occurs no improvement within 4 weeks for athlete's foot and ringworm Do not use on children under 2 years of age unless directed by a doctor. Keep out of reach od children. If swallowed, get medical hel or contact a Poison Control Center right away.
Frequently Asked Questions
What is Tolnaftate used for?
Tolnaftate is an over-the-counter spray applied directly to the skin to help control foot odor. It comes as an aerosol spray that you can purchase without a prescription.
Is Tolnaftate a controlled substance?
Tolnaftate is not classified as a controlled substance by the DEA.
What is the generic name for Tolnaftate?
The generic name for Tolnaftate is Foot Odor Control Spray. There are no other listed brand versions of Foot Odor Control Spray.
What is the NDC code for Tolnaftate 1.13 g/113g?
The NDC (National Drug Code) for Tolnaftate 1.13 g/113g is 36800-023, listed by Topco Associates LLC.
Other Tolnaftate Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)