Drugplain

Jock Itch 10 mg/g

Butenafine Hydrochloride · CREAM · Sun Pharmaceutical Industries, Inc.

6 Recalls on Record
Plain English

Jock Itch is a cream containing butenafine hydrochloride at 10 mg/g, taken topical. Manufactured by Sun Pharmaceutical Industries, Inc..

Key Facts

Brand Name
Jock Itch
Generic Name
Butenafine Hydrochloride
NDC Code (Product)
51672-2101
Manufacturer
Sun Pharmaceutical Industries, Inc.
Strength
10 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
ANDA205181
Marketing Start
11/17/2017

Recall History

6 Recalls on Record
Class II11/17/2020

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

TerminatedVoluntary: Firm initiated
Class I10/01/2021

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

TerminatedVoluntary: Firm initiated
Class III02/19/2013

Novartis Consumer Health

Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.

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

Side Effects Reported to FDA

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

drug ineffective1,964 reports
pain1,108 reports
nausea1,104 reports
off label use1,064 reports
headache1,001 reports
dyspnoea998 reports
fatigue909 reports
diarrhoea816 reports
macular degeneration804 reports
condition aggravated748 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses cures most jock itch (tinea cruris) relieves itching, burning and chafing associated with jock itch

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) or as directed by a doctor supervise children in the use of this product use daily for 2 weeks; if condition persists, consult a doctor this product is not effective on the scalp or nails if nozzle clogs, clean with a pin

Warnings

Warnings For external use only. Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. When using this product do not get into eyes or mouth use only as directed Stop use and ask a doctor if irritation occurs no improvement within 2 weeks Do not use on children under 2 years of age unless directed by a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Jock Itch used for?

Jock Itch contains Butenafine Hydrochloride. It is a cream taken topical. Consult your doctor for specific uses.

Is Jock Itch a controlled substance?

Jock Itch is not classified as a controlled substance by the DEA.

What is the generic name for Jock Itch?

The generic name for Jock Itch is Butenafine Hydrochloride. There are 11 other brand versions of Butenafine Hydrochloride.

What is the NDC code for Jock Itch 10 mg/g?

The NDC (National Drug Code) for Jock Itch 10 mg/g is 51672-2101, listed by Sun Pharmaceutical Industries, Inc..