Derman Antifungal Powder Spray

Manufacturer
Compania Internacional de Comercio, S.A.P.I. de C.V.
Effective date
2026-03-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:49:09

Label at a glance#

ProductDerman Antifungal
Active ingredientTOLNAFTATE
Label structure8 sections

Indications and uses

Proven clinically effective in the treatment of most: • Athlete's foot (tinea pedis) • Jock itch (tinea cruris) • Ringworm (tinea corporis) Clinically proven to prevent most athlete's foot with daily use Relieves • itching • cracking • burning • scaling

Dosage and administration

• clean the affected area and dry thoroughly • shake can well before use: hold can about 6 inches from the area to be treated • apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor • supervise children in the use of this product • use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch • to prevent most athlete's foot apply once or...

Label contents#

Full prescribing information#

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) • Jock itch (tinea cruris) • Ringworm (tinea corporis)
Clinically proven to prevent most athlete's foot with daily use Relieves • itching • cracking • burning • scaling

Warnings

WARNINGS SECTION

For external use only

Flammable: Contents under pressure. Do not puncture or incinetare or store at a temperature above 120°F. Use only as directed. Intentional misuse by deliberately concentrating and inhaling aerosol products can be harmful or fatal. Do not use near flame or spark or white smoking.

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by a doctor.

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation occurs or if there is no improvement whithin 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch)

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

• clean the affected area and dry thoroughly
• shake can well before use: hold can about 6 inches from the area to be treated
• apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor
• supervise children in the use of this product
• use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch
• to prevent most athlete's foot apply once or twice daily (morning and/or night)
• if condition persists longer, consult a doctor
• this product is not effective on the scalp or nails
• 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

Other information

SPL UNCLASSIFIED SECTION

store between 20° and 30°C (68° and 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

BHT, Corn Starch, Isobutane, Kaolin, PPG-12-Buteth-16, SD Alcohol 40-B

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-855-289-3205 (toll-free) or email contact@ksklab.us

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
705934tolnaftate 1 % Powder SprayPSN3
705934tolnaftate 0.01 MG/MG Powder SpraySCD3
705934tolnaftate 1 % Powder SpraySY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54312-230-01Derman Antifungal130 g in 1 BOTTLE, SPRAYAEROSOL, POWDER1303

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54312-23054312-230-01

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-01-06monthly-update2026-06-03 17:51:28

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
Derman AntifungalTOLNAFTATECompania Internacional de Comercio, S.A.P.I. de C.V.5784a783-1056-4d50-8d87-2df4f8e16b092026-03-05WarningsExact identifier
ndc (package): 54312-230-01
ndc (product): 54312-230
ndc11 (package): 54312023001
spl id: 4c4d682d-dea0-cfe0-e063-6394a90a741e
spl set id: 5784a783-1056-4d50-8d87-2df4f8e16b09

Reported adverse events (FAERS/openFDA)#

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