Tolnaftate
FDA Label NDC 53210-1001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Morales Distributors, Inc. for the product Tolnaftate (NDC 53210-1001). 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 (in each gram), purpose, uses, warnings, stop use and ask a doctor if, do not use, 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 Ingredient (In Each Gram)

Tolnaftate 1 percent

Purpose

Antifungal

Uses

  • clinically proven to cure most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete's foot from recurring when used daily
  • effectively soothes and relieves symptoms of athlete's foot, including 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
  • there is no improvement within 4 weeks

Do Not Use

on children under 2 years of age except under the advice and supervision of a doctor.

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
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot, pay special attentional to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • use daily for 4 weeks; if condition persists longer ask a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and night)
  • this product is not effective on the scalp or nails

Other Information

store between 2 degrees and 30 degrees Celsius (36 degrees and 86 degrees Fahrenheit)

Inactive Ingredients

carbomer 940, cetyl alcohol, chlorocresol, dibasic sodium phosphate hydrate, glycerin, glyceryl monostearate, light liquid paraffin, purified water, and stearic acid

Package Label


NDC NO. 53210-1001-0
Tolnafate 1 percent
Cream USP 1 percent Antifungal

Relieves Itching and Burning

Cures and Prevents Athlete's Foot

Prevents and Relieves Itching and Redness

Anti-Itch Cream for Skin Irritations

Compare to Tinactin (R) active ingredient
This product is n ot manufactured or distributed by Schering-Plough Healthcare Products, Inc. owner of the registered Trademark Tinactin

Maximum Strength

Net 1 oz(28.3g)

Exclusively distributed by:
Morales Distributors, Inc
Mayaguez, P.R. 00682

Made in Korea

Box Label (Carton1)

Box Label (Carton1)


Box Label (Carton2)

Box Label (Carton2)


Tube Label (Tube)

Tube Label (Tube)


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