FDA.reportPublic FDA data

Thera plus Antifungal Tolnaftate cream

Manufacturer
FOURSTAR GROUP USA, INC.
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:05

Label at a glance#

ProductThera plus Antifungal Tolnaftate
Active ingredientTOLNAFTATE
Label structure8 sections

Indications and uses

proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis) helps prevent most athlete's foot with daily use  for effective relief of itching , burning , and cracking

Dosage and administration

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 attention to spaces between the toes, wear well-ftting, 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 tw...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Anti-Fungal

Uses

INDICATIONS & USAGE SECTION

  • proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use 
  • for effective relief of itching , burning , and cracking

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 attention to spaces between the toes, wear well-ftting, 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/or night).
  • this product is not effective on the scalp or nails.

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 20° to 25°C (68° to 77°F)
  • lot no & expiration date: see box or crimp of tube

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, ethylparaben, glycerol, glyceryl monostearate, mineral oil, petrolatum, purified water, sodium lauryl sulfate

Questions?

OTC - QUESTIONS SECTION

1-888-296-9067 Weekdays 9 AM to 4 PM EST

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package2Outer Package2Inner Package2Inner Package2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103951tolnaftate 1 % Topical CreamPSN2
103951tolnaftate 10 MG/ML Topical CreamSCD2
103951tolnaftate 1 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-040-01Thera plus Antifungal Tolnaftate14 g in 1 TUBECREAM142
80684-040-01Thera plus Antifungal Tolnaftate1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-040THERA PLUS ANTIFUNGAL TOLNAFTATE (TOLNAFTATE) CREAM [FOURSTAR GROUP USA, INC.]2Current NDC, Legacy NDC, 2 package rows20231027_c628dda8-7a6d-5f3a-e053-2995a90a35f8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80684-04080684-040-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TOLNAFTATE06KB629TKVACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thera plus Antifungal TolnaftateTOLNAFTATEFOURSTAR GROUP USA, INC.c628dda8-7a6d-5f3a-e053-2995a90a35f82023-10-26WarningsExact identifier
ndc (package): 80684-040-01
ndc (product): 80684-040
ndc11 (package): 80684004001
spl id: 08a0d819-d9c5-15e9-e063-6294a90acb44
spl set id: c628dda8-7a6d-5f3a-e053-2995a90a35f8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.