Atopalm Tolnaftate Antifungal
FDA Label NDC 51141-2000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Neopharm Co., Ltd. for the product Atopalm Tolnaftate Antifungal (NDC 51141-2000). 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 ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Package Label.principal Display Panel

Active Ingredients

Tolnaftate 1%

Purpose

Antifungal

Uses

cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)

helps prevent most athletes foot from recurring when used daily

effectively relieves itching, burning and cracking.

Warnings

For external use only

When Using This Product

avoid contact with the eyes

Stop Use And Ask A Doctor If

irritation occurs
if there is no improvement within 4 weeks

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center immediately. Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Directions

wash affected area and pat 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 a day.

use daily for 4 weeks, if condition persists longer, ask a doctor

to prevent athlete's foot, apply once or twice daily (morning and/or night)

this product not effective on the scalp or nails.

Other Information

store between 20 to 30 C (68 to 86)F

see end of carton or tube crimp for lot number and expiration date.

Inactive Ingredients

Water, glycerin, Cetyl alcohol, mineral oil, PEG-15 Glyeryl Stearate, Glyceryl Stearate, Stearic Acid, Carbomer 94-, Cholesterol, Disodium Phosphate, Myristoyl/Palmitoyl Oxostearamide/Archamide MEA, p-Chloro-m-cresol