SPL v4
SPL
SPL Set ID e2f9eedc-3c43-416b-85b5-ba07fb5fb4db
Route
TOPICAL
Published
Effective Date 2022-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Cetostearyl Alcohol Mineral Oil Paraffin Ceteth-20 Propylene Glycol Water Sodium Phosphate, Monobasic, Unspecified Form Chlorocresol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-26

Description

TOLNAFTATE 1%

Purpose

ANTIFUNGAL


Medication Information

Purpose

ANTIFUNGAL

Description

TOLNAFTATE 1%

Uses
  • PROVEN 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 THE TOES AND BURNING FEET

Section 50565-1

Keep out of reach of children

  • If swallowed get medical help or contact Poison Control Center right away.
Section 50567-7

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.

Section 51945-4

NDC 69729-610-05

Warnings

For external use only.

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.

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, VENTILLATED 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 WEKS. IF CONDITION PERSISTS LONGER CONSULT A DOCTOR
  • THIS PRODUCT IS NOT EFFECTIVE ON THE SCALP OR NAILS
Other Information
  • STORE AT 15° TO 30°C (59°F TO 86°F)
  • LOT NO. & EXP. DATE: SEE BOX OR CRIMP OF TUBE
Active Ingredients

TOLNAFTATE 1%

Inactive Ingredients

CETETH-20, CETYL ALCOHOL, CHLOROCRESOL, MINERAL OIL, PROPYLENE GLYCOL, SODIUM PHOSPHATE MONOBASIC, WHITE SOFT PARAFFIN, PURIFIED WATER


Structured Label Content

Uses (USES)
  • PROVEN 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 THE TOES AND BURNING FEET

Section 50565-1 (50565-1)

Keep out of reach of children

  • If swallowed get medical help or contact Poison Control Center right away.
Section 50567-7 (50567-7)

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.

Section 51945-4 (51945-4)

NDC 69729-610-05

Purpose (PURPOSE)

ANTIFUNGAL

Warnings (WARNINGS)

For external use only.

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.

Directions (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, VENTILLATED 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 WEKS. IF CONDITION PERSISTS LONGER CONSULT A DOCTOR
  • THIS PRODUCT IS NOT EFFECTIVE ON THE SCALP OR NAILS
Other Information (OTHER INFORMATION)
  • STORE AT 15° TO 30°C (59°F TO 86°F)
  • LOT NO. & EXP. DATE: SEE BOX OR CRIMP OF TUBE
Active Ingredients (ACTIVE INGREDIENTS)

TOLNAFTATE 1%

Inactive Ingredients (INACTIVE INGREDIENTS)

CETETH-20, CETYL ALCOHOL, CHLOROCRESOL, MINERAL OIL, PROPYLENE GLYCOL, SODIUM PHOSPHATE MONOBASIC, WHITE SOFT PARAFFIN, PURIFIED WATER


Advanced Ingredient Data


Raw Label Data

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