FDA.reportPublic FDA data

Kerasal ® for Athlete's Foot Silky Clear Gel

Manufacturer
Advantice Health, LLC
Effective date
2026-01-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:32:36

Label at a glance#

ProductKerasal for Athletes Foot Silky Clear
Active ingredientTOLNAFTATE
Label structure10 sections

Indications and uses

proven clinically effective in the treatment of most athlete's foot (tinea pedis) clinically proven to prevent most Athlete's Foot with daily use for effective relief of itching, cracking, burning, scaling and discomfort

Dosage and administration

wash the 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 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; if condition persists longer, ask a doctor to prevent athlete's foot, apply once or twice daily (mornin...

Storage and handling

Store between 20-25°C (68-77°F)

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)
  • clinically proven to prevent most Athlete's Foot with daily use
  • for effective relief of itching, cracking, burning, scaling and discomfort

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not useon 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash the 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
  • 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; if condition persists longer, ask a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night, or as directed by a doctor)
  • this product is not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

Store between 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera leaf, alpha tocopheryl acetate, ceramide NG, dimethicone, dimethicone crosspolymer, eucalyptus oil, isododecane, peppermint oil, tea tree oil

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

Tolnaftate Antifungal
Kerasal ®

For Athlete's Foot

Silky Clear Gel

5 IN 1™

CURES
Most Athlete s Foot

PREVENTS
Recurrence

RELIEVES
Itching, Burning And Scaling

NOURISHES
Improves Skin Appearance

DEODORIZES
With Essential Oils

Enriched with Natural Tea Tree Oil,
Aloe, Ceramides & Vitamin E

NET WT 0.42 oz (12 g)

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton
PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313420tolnaftate 1 % Topical GelPSN4
313420tolnaftate 0.01 MG/MG Topical GelSCD4
313420tolnaftate 1 % Topical GelSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16864-100-01Kerasal for Athletes Foot Silky Clear12 g in 1 TUBEGEL124
16864-100-01Kerasal for Athletes Foot Silky Clear1 in 1 CARTONGEL14

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16864-10016864-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CERAMIDE NGC04977SRJ5IACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
EUCALYPTUS OIL2R04ONI662IACT
ISODODECANEA8289P68Y2IACT
PEPPERMINT OILAV092KU4JHIACT
TEA TREE OILVIF565UC2GIACT
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
4849c50d-06a5-1950-e063-6294a90a113154a7bebf-d7f2-414d-8f1a-8669ddefaa8b2026-01-13WarningsExact identifier
spl id: 4849c50d-06a5-1950-e063-6294a90a1131
spl set id: 54a7bebf-d7f2-414d-8f1a-8669ddefaa8b

Reported adverse events (FAERS/openFDA)#

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