Derman Antifungal Cream
FDA Label NDC 81929-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Taisho Pharmaceutical California Inc. for the product Derman Antifungal Cream (NDC 81929-004). 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, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Package Labeling:25g

→ Package Labeling:50g

Drug Facts

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

cures most athlete's foot, jock itch, and ringworm
relieves itching, burning, cracking, scaling, redness, soreness, irritation and discomfort

Warnings

Do Not Use

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

For external use only.

Avoid contact with eyes.

Stop Use And Ask A Doctor If

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

wash affected area and dry thoroughly
apply 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
for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
if condition persists longer, consult a doctor
this product is not effective on the scalp or nails