Smart Sense Tolnaftate Antifungal
FDA Label NDC 49738-424

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kmart Corporation for the product Smart Sense Tolnaftate Antifungal (NDC 49738-424). 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 otc - active ingredient, otc - purpose, warnings, otc - ask doctor, otc - do not use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                              Purpose

Tolnaftate 1%............................................... Antifungal

Otc - Purpose

Uses

  • proved clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • proven effective in the prevention of athlete's foot
  • effectively soothes and relieves itching associated with jock itch, scaly skin between

Warnings

Warnings

For external use only

Otc - Ask Doctor

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Otc - Do Not Use

Do not use on children under 2 years og age except under the advice and supervision of a doctor

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poision Control Center right away. (1-800-222-1222) 

Indications & Usage

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 chage 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

Storage And Handling

Other information

Lot No. & Exp. Date: see box or see crimp of the tube. Store between 20° to 25°C (68° to 77°F)

Inactive Ingredient

Inactive ingredients butylated hydroxytoluene, cetanol, ceteth-20, liquid paraffin, methylparaben, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

Dosage & Administration

DISTRIBUTED BY:

Kmart Corporation

Hoffman Estates, IL 60179

Made in Korea

Package Label.Principal Display Panel

Image Description (Pa 29424.01 Pl Kma Smart Sense Tofnaftate Revised)

Image Description (Pa 29424.01 Pl Kma Smart Sense Tofnaftate Revised)

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