FDA.reportPublic FDA data

TheraCare Antifungal Cream

Manufacturer
Veridian Healthcare | Nantong Health & Beyond Hygienic Products Inc
Effective date
2026-01-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:52:54

Label at a glance#

ProductTheraCare Antifungal Cream
Active ingredientTOLNAFTATE
Label structure10 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

adults and children 2 years of age and over: 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-fitting, ventilated shoes and change shoes and socks at least once daily to prevent athlete's foot, apply once or twice daily (morning and...

Storage and handling

store between 20° to 25°C (68° to 77°F) do not use if tube seal under cap is broken

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

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

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor

OTC - WHEN USING SECTION

When using this productavoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and over:

  • 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-fitting, ventilated shoes and change shoes and socks at least once daily
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

Children under 2 years of age: consult a physician

Other information

STORAGE AND HANDLING SECTION

store between 20° to 25°C (68° to 77°F)

  • do not use if tube seal under cap is broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

ceteth-20, cetostearyl alcohol, cetyl alcohol, chlorocresol, light mineral oil, petrolatum, propylene glycol, sodium phosphate, sodium phosphate dibasic monohydrate, water

Questions?

OTC - QUESTIONS SECTION

Toll Free 1-866-326-1313

PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxbox

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71101-934-012026-01-18C16284748780-13b156c62-3202-fb37-e063-e6dba90a4e07TheraCare Antifungal Cream
71101-934-012025-07-29C16284748780-13b156c62-3202-fb37-e063-e6dba90a4e07TheraCare Antifungal Cream

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71101-93471101-934-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETETH-20I835H2IHHXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHLOROCRESOL36W53O7109IACT
LIGHT MINERAL OILN6K5787QVPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATEBWZ7K44R51IACT
PETROLATUM4T6H12BN9UIACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM PHOSPHATESE337SVY37IACT
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
48acfaae-1d17-8585-e063-6394a90adcf4e2b033ae-e75e-1d10-e053-2a95a90a51ab2026-01-18WarningsExact identifier
spl id: 48acfaae-1d17-8585-e063-6394a90adcf4
spl set id: e2b033ae-e75e-1d10-e053-2a95a90a51ab

Reported adverse events (FAERS/openFDA)#

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