FDA.reportPublic FDA data

RoyceDerm Athlete's foot antifungal cream-214

Manufacturer
RoyceDerm LLC
Effective date
2026-08-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-11 03:01:08

Label at a glance#

ProductRoyceDerm Athletes foot antifungal .cream.
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 2%

DOSAGE & ADMINISTRATION SECTION

  • For effective treatment of most athlete's foot(tinea pedis), ringworm(tinea corporis) and jock itch(tinea cruris).
  • For effective relief of itching, burning and cracking skin.

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

Avoid contact with the eye.

OTC - STOP USE SECTION

Ask a doctor if irritation occurs or if there is no improvement within 2 weeks for athlete's foot and ringworm.

OTC - DO NOT USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

  • Wash affected area well andlet product sit 2-3 minutes before rinsing.
  • Make sure todry affected area thoroughly.
  • Supervise children in the useof this product.
  • For Athlete's foot: pay special attention tothe spaces between the toes;wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
  • Use1-2 times daily. Use daily for 4weeks; if condition persists longer, ask a doctor.
  • This product is not effective on the scalp or nails.

OTHER SAFETY INFORMATION

Store at room temperature 59°-86°F (15°-30°C)

INACTIVE INGREDIENT SECTION

Water, Artemisia Extract, Sophora Flavescens Root Extract, Cnidium Monnieri Fruit Extract, Kochia Scoparia Fruit Extract, Dictamnus
Dasycarpus Root Extract, Smilax Glabra Root Extract

OTC - QUESTIONS SECTION

  • Visit w.roycederm.com
  • Tel:+1(307)461-0958

OTC - PURPOSE SECTION

Antifungal

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

package

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850068161263GTIN-13: 0850068161263
EAN-13: 0850068161263
GTIN-12: 850068161263
UPC-A: 850068161263
GTIN storage (14 digits): 00850068161263		package.jpg

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
85424-03185424-031-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
WATER059QF0KO0RIACT
WORMWOODF84709P2XVIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
CNIDIUM MONNIERI FRUIT OILJK0MS9P8YLIACT
BASSIA SCOPARIA FRUIT04W97Z676YIACT
DICTAMNUS DASYCARPUS ROOT6153LEN214IACT
SMILAX GLABRA TUBERPES3YXA3LRIACT

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
RoyceDerm Athletes foot antifungal .cream.MICONAZOLE NITRATE 2%RoyceDerm LLC58d23aa0-497e-4ece-e063-6294a90aef662026-08-11WarningsExact identifier
ndc (package): 85424-031-01
ndc (product): 85424-031
ndc11 (package): 85424003101
spl id: 58d23aa0-497f-4ece-e063-6294a90aef66
spl set id: 58d23aa0-497e-4ece-e063-6294a90aef66

Reported adverse events (FAERS/openFDA)#

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