Drugplain

Tolnaftate 1.3 g/130g

Tolnaftate Jock Itch Powder Spray - Talc Free · AEROSOL, SPRAY · Meijer Distribution Inc

10 Recalls on Record
Plain English

Tolnaftate is a aerosol, spray containing tolnaftate jock itch powder spray - talc free at 1.3 g/130g, taken topical. Manufactured by Meijer Distribution Inc.

Key Facts

Brand Name
Tolnaftate
Generic Name
Tolnaftate Jock Itch Powder Spray - Talc Free
NDC Code (Product)
41250-563
Manufacturer
Meijer Distribution Inc
Strength
1.3 g/130g
Dosage Form
AEROSOL, SPRAY
Route
TOPICAL
Marketing Status
Application #
M005
Marketing Start
09/19/2020

Recall History

10 Recalls on Record
Class I10/01/2021

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

TerminatedVoluntary: Firm initiated
Class I10/01/2021

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

TerminatedVoluntary: Firm initiated
Class II10/01/2021

Bayer Healthcare Pharmaceuticals Inc.

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

TerminatedVoluntary: Firm initiated
Class I10/01/2021

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

TerminatedVoluntary: Firm initiated
Class II10/01/2021

Bayer Healthcare Pharmaceuticals Inc.

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

TerminatedVoluntary: Firm initiated
Class II10/01/2021

Bayer Healthcare Pharmaceuticals Inc.

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

TerminatedVoluntary: Firm initiated
Class I10/01/2021

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

TerminatedVoluntary: Firm initiated
Class II10/01/2021

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.

TerminatedVoluntary: Firm initiated
Class II08/09/2023

Ecometics, Inc.

CGMP Deviations: Products not manufactured under current good manufacturing practices.

CompletedVoluntary: Firm initiated
Class II10/01/2021

Bayer Healthcare Pharmaceuticals Inc.

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

arthralgia17 reports
diarrhoea16 reports
headache13 reports
rash erythematous13 reports
blood potassium increased12 reports
fatigue12 reports
bronchopulmonary aspergillosis11 reports
dyspnoea11 reports
mucormycosis11 reports
off label use11 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 contains Tolnaftate Jock Itch Powder Spray - Talc Free. It is a aerosol, spray taken topical. Consult your doctor for specific uses.

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 Tolnaftate Jock Itch Powder Spray - Talc Free. There are 2 other brand versions of Tolnaftate Jock Itch Powder Spray - Talc Free.

What is the NDC code for Tolnaftate 1.3 g/130g?

The NDC (National Drug Code) for Tolnaftate 1.3 g/130g is 41250-563, listed by Meijer Distribution Inc.

Product NDC

41250-563

Package NDC

41250-563-46

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)