Fungoid Tincture
FDA Label NDC 0884-0293

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pedinol Pharmacal, Inc. for the product Fungoid Tincture (NDC 0884-0293). 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, flammable:, do not use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Flammable:

→ Do Not Use

→ When Using This Product

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Fungoid Tincture – 1 Fl. Oz. (29.57 Ml) Carton

Other

Drug Facts

Active Ingredient

Miconazole nitrate 2% USP

Purpose

Antifungal

Uses

cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
for effective relief of itchy, scaly skin between the toes

Warnings

For external use only

Flammable:

Do not use while smoking or near heat or flame.

Do Not Use

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

When Using This Product

avoid contact with the eyes.
If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

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
apply a thin layer of the product 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 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
if condition persists longer, consult a doctor
this product is not effective on scalp or nails.