FDA.reportPublic FDA data

Topcare Tolnaftate Powder Spray

Manufacturer
Topco Associates LLC
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:42:37

Label at a glance#

ProductTolnafate
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

cures most athlete's foot (tinea pedis) and ringworm (tinea corporis) and jock itch (tinea cruris) can prevent recurrence of most athlete's foot relieves sypmtoms of athlete's foot, including itching, burning, cracking, and chafing associated with jock itch

Dosage and administration

wash affected area and dry thoroughly shake can well and spray 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 to prevent athlete's foot, apply once or twice daily (morning and/or night) for athlete's foot, pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis) and jock itch (tinea cruris)
  • can prevent recurrence of most athlete's foot
  • relieves sypmtoms of athlete's foot, including itching, burning, cracking, and chafing associated with jock itch

WARNINGS SECTION

For external use only.

Flammable:

SAFE HANDLING WARNING SECTION

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes or mouth
  • use only as directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch
  • irritation occurs

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area and dry thoroughly
  • shake can well and spray 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
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • 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
  • use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch
  • if condition persists, consult a doctor
  • this product is not effective on the scalp or nails
  • if nozzle clogs, clean with a pin

Other information

OTHER SAFETY INFORMATION

store between 20º and 30ºC (68ºF and 86º)

Inactive ingredients

INACTIVE INGREDIENT SECTION

BHT, isobutane, kaolin, PPG-12-Buteth-16, SD alcohol 40-B, zea mays (corn) starch

Questions?

OTC - QUESTIONS SECTION

Call 1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare health

MEDICATED

Athlete's Foot

Powder Spray

TOLNAFTATE 1% • ANTIFUNGAL

  • Cures Most Athlete's Foot & Prevents Recurrences
  • Relieves Itching, Cracking & Burning
  • Talc-Free

NET WT 4.6 OZ (130 g)

tolnaftate powder spraytolnaftate powder spray

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
705934tolnaftate 1 % Powder SprayPSN7
705934tolnaftate 0.01 MG/MG Powder SpraySCD7
705934tolnaftate 1 % Powder SpraySY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-876-46Tolnafate130 g in 1 CANAEROSOL, SPRAY1307

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-87636800-876-46

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ISOBUTANEBXR49TP611IACT
KAOLIN24H4NWX5COIACT
PPG-12-BUTETH-1658CG7042J1IACT
ALCOHOL3K9958V90MIACT
ZEA MAYS SUBSP. MAYS WHOLE1G5HNE09V8IACT
TOLNAFTATE06KB629TKVACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-12-11full-release2026-06-01 00:42:26

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
TolnafateTOLNAFTATE POWDER SPRAYTopco Associates LLC5f8ae9ab-5e34-7a60-e053-2991aa0a98172025-11-06WarningsExact identifier
ndc (package): 36800-876-46
ndc (product): 36800-876
ndc11 (package): 36800087646
spl id: 42f45cbf-49ff-8971-e063-6394a90a291d
spl set id: 5f8ae9ab-5e34-7a60-e053-2991aa0a9817

Reported adverse events (FAERS/openFDA)#

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