sunmark

Manufacturer
A-S Medication Solutions
Effective date
2023-12-16
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:04:44

Label at a glance#

Productsunmark antifungal
Active ingredientTOLNAFTATE
Label structure11 sections

Indications and uses

clinically proven to cure most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) helps prevent most athlete's foot from recurring when used daily effectively soothes and relieves symptoms of athlete's foot, including 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 this product is not effective on scalp or nails pay special attention to spaces between toes wear well-fitting shoes, change shoes and socks at least once daily For athlete's foot and ringworm use daily for 4 weeks For jock itch use daily for 2 weeks If condition...

Storage and handling

Store between 15° - 30°C (59° - 86°F) See end panel of carton and tube crimp for lot number and expiration date

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

  • clinically proven to cure most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • helps prevent most athlete's foot from recurring when used daily
  • effectively soothes and relieves symptoms of athlete's foot, including itching, burning and cracking

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only

OTC - WHEN USING SECTION

When using this product 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 (for athlete's foot or ringworm) or within 2 weeks (for jock itch)

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

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 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
  • this product is not effective on scalp or nails

For athlete's foot

SPL UNCLASSIFIED SECTION

  • pay special attention to spaces between toes
  • wear well-fitting shoes, change shoes and socks at least once daily

SPL UNCLASSIFIED SECTION

For athlete's foot and ringworm use daily for 4 weeks

SPL UNCLASSIFIED SECTION

For jock itch use daily for 2 weeks
If condition persists longer, consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • Store between 15° - 30°C (59° - 86°F)
  • See end panel of carton and tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

SPL UNCLASSIFIED SECTION

Distributed by McKesson
One Post Street
San Francisco, CA 94104

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-3358

NDC: 50090-3358-0 15 g in a TUBE / 1 in a CARTON

Tolnaftate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103951tolnaftate 1 % Topical CreamPSN9
103951tolnaftate 10 MG/ML Topical CreamSCD9
103951tolnaftate 1 % Topical CreamSY9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3358-0sunmark antifungal1 in 1 CARTONCREAM19
50090-3358-0sunmark antifungal15 g in 1 TUBECREAM159

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3358SUNMARK ANTIFUNGAL (TOLNAFTATE) CREAM [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20231217_6f85fbb0-297c-4949-83f2-ed9a52172154.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3358-0GM - Gram50090-3358b2433655-9852-4534-83af-6fac4e7f784212019-05-02
49348-155-29GM - Gram49348-15525c29254-5bd6-4929-9c64-47955ba1ba8512013-02-19

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-335850090-3358-0
49348-155

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sunmark antifungalTOLNAFTATEStrategic Sourcing Services LLCd0c30c74-9472-4978-9623-8c7dbeb994112025-07-07WarningsExact identifier
ndc (product): 49348-155
sunmark antifungalTOLNAFTATEA-S Medication Solutions6f85fbb0-297c-4949-83f2-ed9a521721542023-12-16WarningsExact identifier
ndc (package): 50090-3358-0
ndc (product): 50090-3358
ndc11 (package): 50090335800
spl id: 3802e6c5-c6f6-4ed5-80c9-97e5b0a38a5d
spl set id: 6f85fbb0-297c-4949-83f2-ed9a52172154

Reported adverse events (FAERS/openFDA)#

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