Athletes Foot Cream
FDA Label NDC 36800-049

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Athletes Foot (NDC 36800-049). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

Active Ingredient

Butenafine hydrochloride 1%

Purpose

Antifungal

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

Warnings

For external use only

Do Not Use

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

Otc - When Using

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

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

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 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

      Figure (Butenafine 01)

      Figure (Butenafine 01)


      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

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

Questions?

Call 1-888-423-0139

Principal Display Panel - 12 G Tube Carton

TopCare®

NDC 36800-049-01

CLINICALLY PROVEN TO CURE MOST ATHLETE'S FOOT BETWEEN THE TOES

Butenafine
Hydrochloride Cream 1%
Antifungal

QUALITY
GUARANTEED

COMPARE TO
LOTRIMIN ULTRA®
active ingredient*

NET WT 12 g (0.42 oz)

Principal Display Panel (12 g Tube Carton)

Principal Display Panel (12 g Tube Carton)

* Please review the disclaimer below.