FDA.reportPublic FDA data

Initial Drug Listing - RoyceDerm Tinea ANTIFUNGAL SOAP-175

Manufacturer
RoyceDerm LLC
Effective date
2026-04-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:54:50

Label at a glance#

ProductRoyceDerm Tinea ANTIFUNGAL .soap.
Active ingredientCLOTRIMAZOLE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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 & discomfort associated with these conditions.

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

Avoid contact with the eye.

OTC - ASK DOCTOR SECTION

Stop and aska 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.

OTC - DO NOT USE SECTION

Do not use on children under 2 of age except under the advice and supervision fof 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 the affected area and dry thoroughly.
  • Lather and apply to affected area. Leave onfor several minutes before rinsing thoroughly. Use 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 for4 weeks. For jock itch, use daily for 2 weeks.
  • 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

Sorbitol, Sucrose, Stearic Acid, Propanediol, Sodium Lauroamphoacetate, Water, LauricAcid, 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
251267clotrimazole 0.01 MG/MG Medicated Bar SoapSCD1
251267clotrimazole 1 % Medicated Bar SoapSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE 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
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-022-01RoyceDerm Tinea ANTIFUNGAL .soap.226 g in 1 CARTONSOAP2261

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-02285424-022-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPANEDIOL5965N8W85TIACT
CLOTRIMAZOLEG07GZ97H65ACTIB
SODIUM HYDROXIDE55X04QC32IIACT
SUCROSEC151H8M554IACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
POTASSIUM COCOYL GLYCINATEWZ70FUF22UIACT
STEARIC ACID4ELV7Z65APIACT
LAURIC ACID1160N9NU9UIACT
GLYCERINPDC6A3C0OXIACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT
SULFUR70FD1KFU70IACT
WATER059QF0KO0RIACT
FRAGRANCE LAVENDER ORC18009791B40MIN2W5IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
SODIUM LAUROAMPHOACETATESLK428451LIACT
SORBITOL506T60A25RIACT

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
RoyceDerm tinea ANTIFUNGAL .cream. and .soap.CREAM AND SOAPRoyceDerm LLC4f4ef2d0-98fa-e791-e063-6394a90a70452026-04-12WarningsExact identifier
ndc (package): 85424-022-01
ndc11 (package): 85424002201
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
spl id: 4e889f2b-9ea2-b1a6-e063-6394a90a4654
spl set id: 4e889f2b-9ea1-b1a6-e063-6394a90a4654

Reported adverse events (FAERS/openFDA)#

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