Drugplain

Butenafine Hydrochloride 10 mg/g

Butenafine Hydrochloride · CREAM · YYBA CORP

1 Recall on Record
Plain English

Butenafine Hydrochloride is a cream containing butenafine hydrochloride at 10 mg/g, taken topical. Manufactured by YYBA CORP.

Key Facts

Brand Name
Butenafine Hydrochloride
Generic Name
Butenafine Hydrochloride
NDC Code (Product)
73581-210
Manufacturer
YYBA CORP
Strength
10 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
ANDA205181
Marketing Start
10/12/2023

Recall History

1 Recall on Record
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

Side Effects Reported to FDA

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

drug ineffective17 reports
accidental exposure to product4 reports
aspartate aminotransferase increased4 reports
condition aggravated4 reports
alanine aminotransferase increased3 reports
application site pain3 reports
blood creatinine increased3 reports
off label use3 reports
blood lactate dehydrogenase increased2 reports
cerebral infarction2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. cures most jock itch and ringworm relieves itching, burning, cracking, and scaling which accompany these conditions

Dosage & Administration

Directions adults and children 12 years and older: use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. Apply between and around the toes for jock itch and ringworm: apply once a day to affected skin for 2 weeks or as directed by a doctor. wash hands after each use children under 12 years: ask a doctor Figure

Warnings

Warnings For external use only Do not use on nails or scalp in or near the mouth or the eyes for vaginal yeast infections When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if too much irritation occurs or irritation gets worse Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Butenafine Hydrochloride used for?

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

Is Butenafine Hydrochloride a controlled substance?

Butenafine Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Butenafine Hydrochloride?

The generic name for Butenafine Hydrochloride is Butenafine Hydrochloride. There are 10 other brand versions of Butenafine Hydrochloride.

What is the NDC code for Butenafine Hydrochloride 10 mg/g?

The NDC (National Drug Code) for Butenafine Hydrochloride 10 mg/g is 73581-210, listed by YYBA CORP.

Product NDC

73581-210

Package NDC

73581-210-02

Other Butenafine Hydrochloride Dosages

Other Butenafine Brands

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

Data from openFDA · Public domain (CC0 1.0)