Athletes Foot Aerosol, Powder
FDA Label NDC 56104-912

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Premier Brands Of America Inc for the product Athletes Foot (NDC 56104-912). 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 active ingredient, purpose, uses, warnings, extremely flammable:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

  • cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
  • relieves itching, burning and cracking

Warnings

For external use only.

Extremely Flammable:

Keep away from fire, sparks, and heated surfaces. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

When Using This Product

  • avoid spraying in eyes
  • use only as directed
  • intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal

Stop Use And Ask A Doctor If

  • irritation occurs
  • there is no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch; if conditions persist, consult a doctor
  • this product is not effective on the scalp or nails

Other Information

  • store between 20° and 30°C (68° and 86°F)
  • if nozzle clogs, clean with a pin

Inactive Ingredients

ISOBUTANE, SD ALCOHOL 40-B, KAOLIN, ZEA MAYS (CORN) STARCH, DISTEARDIMONIUM HECTORITE

Questions?

Call 1-866-964-0939

Principal Display Panel

premier
solutions

Antifungal

ATHLETE'S
FOOT
Powder Spray

MICONAZOLE NITRATE 2% /
ANTIFUNGAL

CURES MOST
ATHLETE'S FOOT
Relieves itching, cracking & burning
Comforts & refreshes
Talc-free

NET WT. 4.6 OZ (130 g)

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