SPL v1
SPL
SPL Set ID 3a735ca5-4717-43a1-ab42-76f310bcfe00
Route
TOPICAL
Published
Effective Date 2025-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Butenafine (10 mg)
Inactive Ingredients
Tea Tree Oil Benzyl Alcohol Cetyl Alcohol Glycerin Glyceryl Stearate Se Ceteth-23 Propylene Glycol Dicaprylate Water Sodium Benzoate Stearic Acid Trolamine Petrolatum

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-02-27

Description

Butenafine hydrochloride 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Butenafine hydrochloride 1%

Uses

● cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.

● relieves itching, burning, cracking, and scaling which accompany these conditions

Section 50565-1

Warnings

For external use only



Do not use

  • on nails or scalp
  •  in or near the mouth or the eyes
  •  or vaginal yeast infections

  • When using this productdo not get into the eyes. If eye contact occurs, rinse thoroughly with water.
  • Stop use and ask a doctor iftoo 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.
Directions

adults and children 12 years and over:

      ● wash the affected skin with the soap and water and dry completly before applying.

      ● to open the applicator, twist the base to the ON position. Squeeze tube to dispence cream.

      ● 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.

  • Wipe applicator tip with a tissue and close the applicator by twisting the base to the OFF position
  • wash hands after each use.

Childern under 12 years: ask a doctor

Product Label

Other Information 

● store between 20º to 25º C (68º to 77º F)

Inactive Ingredients

Tea Tree Oil, benzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate SE, polyoxyethylene (23) cetyl ether, propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, trolamine, white petrolatum

Active Ingredient                                                          

Butenafine hydrochloride 1%


Structured Label Content

Uses

● cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.

● relieves itching, burning, cracking, and scaling which accompany these conditions

Section 50565-1 (50565-1)

Purpose

Antifungal

Warnings

For external use only



Do not use

  • on nails or scalp
  •  in or near the mouth or the eyes
  •  or vaginal yeast infections

  • When using this productdo not get into the eyes. If eye contact occurs, rinse thoroughly with water.
  • Stop use and ask a doctor iftoo 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.
Directions

adults and children 12 years and over:

      ● wash the affected skin with the soap and water and dry completly before applying.

      ● to open the applicator, twist the base to the ON position. Squeeze tube to dispence cream.

      ● 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.

  • Wipe applicator tip with a tissue and close the applicator by twisting the base to the OFF position
  • wash hands after each use.

Childern under 12 years: ask a doctor

Product Label (Product label)

Other Information 

● store between 20º to 25º C (68º to 77º F)

Inactive Ingredients (Inactive ingredients)

Tea Tree Oil, benzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate SE, polyoxyethylene (23) cetyl ether, propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, trolamine, white petrolatum

Active Ingredient                                                          

Butenafine hydrochloride 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)