Drugplain

Lotrimin 10 mg/g

Clotrimazole · CREAM · Bayer HealthCare LLC.

10 Recalls on Record
Plain English

Lotrimin is a cream containing clotrimazole at 10 mg/g, taken topical. Manufactured by Bayer HealthCare LLC..

Key Facts

Brand Name
Lotrimin
Generic Name
Clotrimazole
NDC Code (Product)
11523-6549
Manufacturer
Bayer HealthCare LLC.
Strength
10 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M005
Drug Class
Azole Antifungal [EPC]
Marketing Start
01/02/2009

Recall History

10 Recalls on Record
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 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 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 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

Side Effects Reported to FDA

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

drug ineffective1,715 reports
off label use876 reports
nausea868 reports
pain859 reports
macular degeneration804 reports
dyspnoea781 reports
headache772 reports
fatigue699 reports
diarrhoea656 reports
pyrexia557 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), jock itch (tinea cruris) and ringworm (tinea corporis) for effective relief of itching, cracking, burning, scaling and discomfort

Dosage & Administration

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

Warnings

Warnings For external use only Flammable For external use only flammable: Do not use near heat, flame, or while smoking Do not use on children under 2 years of age unless directed by a doctor 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) Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Lotrimin used for?

Lotrimin contains Clotrimazole. It is a cream taken topical. Consult your doctor for specific uses.

Is Lotrimin a controlled substance?

Lotrimin is not classified as a controlled substance by the DEA.

What is the generic name for Lotrimin?

The generic name for Lotrimin is Clotrimazole. There are 11 other brand versions of Clotrimazole.

What is the NDC code for Lotrimin 10 mg/g?

The NDC (National Drug Code) for Lotrimin 10 mg/g is 11523-6549, listed by Bayer HealthCare LLC..