Derman Antifungal Aerosol, Powder
FDA Label NDC 54312-230

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Compania Internacional De Comercio, S.a.p.i. De C.v. for the product Derman Antifungal (NDC 54312-230). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Proven clinically effective in the treatment of most:

• Athlete's foot (tinea pedis) • Jock itch (tinea cruris) • Ringworm (tinea corporis)
Clinically proven to prevent most athlete's foot with daily use Relieves • itching • cracking • burning • scaling

Warnings

For external use only

Flammable: Contents under pressure. Do not puncture or incinetare or store at a temperature above 120°F. Use only as directed. Intentional misuse by deliberately concentrating and inhaling aerosol products can be harmful or fatal. Do not use near flame or spark or white smoking.

Do Not Use

on children under 2 years of age unless directed by a doctor.

When Using This Product

avoid contact with the eyes

Stop Use And Ask A Doctor

if irritation occurs or if there is no improvement whithin 4 weeks (for athlete's foot or ringworm) or within 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

• clean the affected area and dry thoroughly
• shake can well before use: hold can about 6 inches from the area to be treated
• apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor
• supervise children in the use of this product
• use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch
• to prevent most athlete's foot apply once or twice daily (morning and/or night)
• if condition persists longer, consult a doctor
• this product is not effective on the scalp or nails
• 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

Other Information

store between 20° and 30°C (68° and 86°F)

Inactive Ingredients

BHT, Corn Starch, Isobutane, Kaolin, PPG-12-Buteth-16, SD Alcohol 40-B

Package Labeling:

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