FDA.reportPublic FDA data

Signature Care Athletes Foot

Manufacturer
Formulated Solutions, LLC
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:59

Label at a glance#

ProductSignature Care Athletes Foot
Active ingredientMICONAZOLE NITRATE
Label structure8 sections

Indications and uses

proven clinically effective in the treatment of most athlet's foot (Tinea pedis), Jack itch (tinea cruis) and ringworm (tinea corporis) for effective relief if itching, cracking, burning, scalling and discomfort

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) supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toas, wear well-fitting, ventilated shoes and change shoes and sucks at least once daily for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 week...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • proven clinically effective in the treatment of most athlet's foot (Tinea pedis), Jack itch (tinea cruis) and ringworm (tinea corporis)
  • for effective relief if itching, cracking, burning, scalling and discomfort

Warnings

WARNINGS SECTION

For external use only

Flammable: Do not use while smoking or near heat or flame

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
  • use only as directed intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
  • contents under pressure. Do nor punture or incinerate. Do not store at temperature above 120°F (49°C).

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 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 (1-800-222-1222).

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)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toas, wear well-fitting, ventilated shoes and change shoes and sucks 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 persist longer, ask a doctor
  • this product is not effective on the scalp or nails
  • in case of clpgging, clean nozzle with a pin

Other information

SPL UNCLASSIFIED SECTION

store at 20-25°C (68-77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alcohol denat, aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propylene carbonate, sorbitan monoleate, stearalkonium hectorite, talc

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nitrate 812Nitrate 812

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998533miconazole nitrate 2 % Topical SprayPSN3
998533miconazole nitrate 20 MG/ML Topical SpraySCD3
998533miconazole nitrate 2 % Topical SpraySY3
998533miconazole nitrate 3 GM in 150 GM Topical SpraySY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23667-812-01Signature Care Athletes Foot130 g in 1 CANSPRAY1303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23667-812SIGNATURE CARE ATHLETES FOOT (MICONAZOLE NITRATE) SPRAY [FORMULATED SOLUTIONS, LLC]3Legacy NDC, 1 package rows20231201_46c5fa20-12aa-272e-e054-00144ff8d46c.zip

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
23667-81223667-812-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
ISOBUTANEBXR49TP611IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PROPYLENE CARBONATE8D08K3S51EIACT
SORBITAN6O92ICV9RUIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
TALC7SEV7J4R1UIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB

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
567feddd-b925-0f4e-e063-6394a90a722146c5fa20-12aa-272e-e054-00144ff8d46c2026-07-13WarningsExact identifier
spl set id: 46c5fa20-12aa-272e-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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