Butenafine Hydrochloride

Butenafine Hydrochloride
SPL v4
SPL
SPL Set ID 098dee89-0f7b-4341-a691-bfe6077ff353
Route
TOPICAL
Published
Effective Date 2023-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
ANDA Active Since 2023-04-19

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor iftoo much irritation occurs or irritation gets worse

Section 50567-7

When using this productdo not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Warnings

For external use only

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
Do Not Use
  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections
Questions?

Call 1-866-923-4914

Active Ingredient

Butenafine hydrochloride 1%

Other Information
  • do not use if seal on tube is broken or not visible
  • store between 20° to 25° C (68° to 77° F)
Inactive Ingredients

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

Principal Display Panel 30 G Tube Carton

Signature

care ®

Quality Guaranteed

Athlete's Foot Cream ULTRA

BUTENAFINE HYDROCHLORIDE 1% CREAM

ANTIFUNGAL

Contains the Drug: BUTENAFINE HYDROCHLORIDE

  • Prescription Strength • Relieves Itching, Burning and Cracking
  • Clinically Proven to Cure most Athlete's Foot between the Toes

NET WT 1 OZ (30 g)


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor iftoo much irritation occurs or irritation gets worse

Section 50567-7 (50567-7)

When using this productdo not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Purpose

Antifungal

Warnings

For external use only

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
Do Not Use (Do not use)
  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections
Questions?

Call 1-866-923-4914

Active Ingredient (Active ingredient)

Butenafine hydrochloride 1%

Other Information (Other information)
  • do not use if seal on tube is broken or not visible
  • store between 20° to 25° C (68° to 77° F)
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel 30 G Tube Carton (PRINCIPAL DISPLAY PANEL - 30 g Tube Carton)

Signature

care ®

Quality Guaranteed

Athlete's Foot Cream ULTRA

BUTENAFINE HYDROCHLORIDE 1% CREAM

ANTIFUNGAL

Contains the Drug: BUTENAFINE HYDROCHLORIDE

  • Prescription Strength • Relieves Itching, Burning and Cracking
  • Clinically Proven to Cure most Athlete's Foot between the Toes

NET WT 1 OZ (30 g)


Advanced Ingredient Data


Raw Label Data

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