Initial Drug Listing - RoyceDerm tinea ANTIFUNGAL CREAM and SOAP-176

Manufacturer
RoyceDerm LLC
Effective date
2026-04-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:55:49

Label at a glance#

ProductRoyceDerm tinea ANTIFUNGAL .cream. and .soap.
Active ingredientCLOTRIMAZOLE, MICONAZOLE NITRATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Clotrimazole 1%

OTC - PURPOSE SECTION

Antifungal

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, cracking and discomfort associated with these conditions.

WARNINGS SECTION

  • For external use only
  • When using this product, avoid contact with the eye.
  • Stop and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.
  • Do not use on children under 2 of age except under the advice and supervision of a doctro.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

  • Wash the affected area and dry thoroughly.
  • Apply a thin layer of the productover affected area twice daily (morning and night) or as directed by a doctor.
  • Supervise children in the use of this product.
  • For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and 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 persistslonger, ask a doctor.
  • This product is not effective on the scalp or nails.

OTHER SAFETY INFORMATION

Store at room temperature and out of direct sunlight.

INACTIVE INGREDIENT SECTION

Cream:

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

Soap:

Sorbitol, Sucrose, Stearic Acid, Propanediol, Sodium Lauroamphoacetate, Water,Lauric Acid, Glycerin, Sodium Hydroxide, Butyrospermum Parkii (Shea) Butter,Aloe Barbadensis Leaf Extract, Potassium Cocoyl Glycinate, Olea Europaea (Olive)Fruit Oil, Sulfur, Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251267clotrimazole 1 % Medicated Bar SoapPSN1
998483miconazole nitrate 2 % Topical CreamPSN1
251267clotrimazole 0.01 MG/MG Medicated Bar SoapSCD1
998483miconazole nitrate 20 MG/ML Topical CreamSCD1
251267clotrimazole 1 % Medicated Bar SoapSY1
998483miconazole nitrate 2 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-011-01RoyceDerm tinea ANTIFUNGAL .cream. and .soap.57 g in 1 TUBECREAM1 g in 5720 mg in 1g1
85424-022-01RoyceDerm tinea ANTIFUNGAL .cream. and .soap.226 g in 1 CARTONSOAP2 g in 2262.26 g in 226g1
85424-023-01RoyceDerm tinea ANTIFUNGAL .cream. and .soap.1 in 1 CARTONKIT11

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-02385424-023-01
85424-02285424-022-01
85424-01185424-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RoyceDerm Tinea Antifungal CreamMICONAZOLE NITRATE 2%RoyceDerm LLC40089a7d-c893-4e90-e063-6294a90aa6f92026-05-06WarningsExact identifier
ndc (package): 85424-011-01
ndc (product): 85424-011
ndc11 (package): 85424001101
RoyceDerm tinea ANTIFUNGAL .cream. and .soap.CREAM AND SOAPRoyceDerm LLC4f4ef2d0-98fa-e791-e063-6394a90a70452026-04-12WarningsExact identifier
ndc (package): 85424-022-01
ndc (package): 85424-023-01
ndc (package): 85424-011-01
ndc (product): 85424-023
ndc11 (package): 85424002301
ndc11 (package): 85424002201
ndc11 (package): 85424001101
spl id: 4f4ef2d0-98fb-e791-e063-6394a90a7045
spl set id: 4f4ef2d0-98fa-e791-e063-6394a90a7045
RoyceDerm Tinea ANTIFUNGAL .soap.CLOTRIMAZOLE 1%RoyceDerm LLC4e889f2b-9ea1-b1a6-e063-6394a90a46542026-04-03WarningsExact identifier
ndc (package): 85424-022-01
ndc (product): 85424-022
ndc11 (package): 85424002201