Butenafine

Mechanism-of-action class: Ergosterol Synthesis Inhibitors.

• Uses cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.ICD-10: B35.3

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 1 week twice a day or 4 weeks once a day 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 image

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.

• Dec 7, 2001NDANDA021307Bayer Healthcare Llc
• Nov 16, 2017ANDAANDA205181Sun Pharma Canada

1. 1Drug Ineffective18232%
2. 2Off Label Use5910%
3. 3Product Use Issue447.7%
4. 4Product Use In Unapproved Indication345.9%
5. 5Pruritus315.4%
6. 6Condition Aggravated295.0%
7. 7Rash213.7%
8. 8Drug Ineffective For Unapproved Indication203.5%
9. 9Drug Effect Decreased193.3%
10. 10Erythema193.3%
11. 11Drug Effective For Unapproved Indication173.0%
12. 12Product Administered At Inappropriate Site132.3%
13. 13Burning Sensation122.1%
14. 14Pain122.1%
15. 15Product Prescribing Issue122.1%

The 8 most recently updated of 8 ClinicalTrials.gov registrations naming Butenafine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test)
  Completed · Phase 3 · Interventional · 225 enrolled · Bayer
  NCT04531540updated 2020-11-17
• Study to Find Out if Cream V61-044 Used to Treat Fungal Infections Causes an Allergic Skin Reaction to Sunlight in Healthy Participants
  Completed · Phase 3 · Interventional · 137 enrolled · Bayer
  NCT04532164updated 2020-11-16
• Study to Learn More About the Potential of Antifungal Cream V61-044 Containing Trolamine to Cause Irritant Reaction of the Skin to Ultra Violet Light in Healthy Human Subjects
  Completed · Phase 3 · Interventional · 32 enrolled · Bayer
  NCT04531527updated 2020-11-13
• Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test)
  Completed · Phase 3 · Interventional · 32 enrolled · Bayer
  NCT04531813updated 2020-09-25
• SINGLE-APPLICATION TERBINAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION VERSUS A SINGLE-APPLICATION BUTENAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION FOR THE TREATMENT OF TINEA PEDIS
  Unknown · Phase 2 · Interventional · 42 enrolled · United Laboratories
  NCT03999437updated 2019-06-26
• Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis
  Completed · Phase 1 · Interventional · 707 enrolled · Sun Pharmaceutical Industries, Inc.
  NCT01580878updated 2017-05-05
• Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis
  Terminated · Phase 1 · Interventional · 428 enrolled · Sun Pharmaceutical Industries, Inc.
  NCT01119742updated 2014-05-06
• Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
  Completed · Phase 1 · Interventional · 548 enrolled · Sun Pharmaceutical Industries, Inc.
  NCT00835510updated 2014-02-04

Frequently asked questions

How does Butenafine work?

Mechanism-of-action class: Ergosterol Synthesis Inhibitors.

What is Butenafine used for?

According to FDA labeling, Butenafine carries indications including: Uses cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Butenafine?

Butenafine is classified as Other antifungals for topical use, Benzylamine Antifungal, Ergosterol Synthesis Inhibitors, Decreased Cell Wall Integrity.

What are the brand names for Butenafine?

Butenafine is marketed under brand names including Mentax.