FDA.reportPublic FDA data

Clotrimazole

Manufacturer
Haikou Pucao Trading Co.,Ltd
Effective date
2025-03-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:57:39

Label at a glance#

ProductRoycederm Tinea Versicolor Relief Soap.
Active ingredientCLOTRIMAZOLE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Coltrimazole 1%

OTC - PURPOSE SECTION

Anti-fungal

INDICATIONS & USAGE SECTION

Treats and prevents fungal infections including tinea versicolor, ringworm, athlete's foot, and jock itch.

OTC - DO NOT USE SECTION

For external use only. Do not use on children under two years of age unless directed by a physician.

OTC - STOP USE SECTION

Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician.

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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Apply to body and feet during shower or bath. Gently message over the entire body, focusing on affected areas. Rinse thoroughly with water. Use twice daily or as directed by a doctor.
For best results use with RoyceDerm Tinea Treatment Cream.

OTHER SAFETY INFORMATION

Store at room temperature and out of direct sunlight.

INACTIVE INGREDIENT SECTION

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

Tinea packagingTinea packaging

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85261-311-01Roycederm Tinea Versicolor Relief Soap.232 g in 1 CARTONSOAP2321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85261-311ROYCEDERM TINEA VERSICOLOR RELIEF SOAP. (CLOTRIMAZOLE) SOAP [HAIKOU PUCAO TRADING CO.,LTD]11 package rows20250325_2fc7544d-29be-1f07-e063-6294a90a5e44.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85261-31185261-311-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT
GLYCERINPDC6A3C0OXIACT
FRAGRANCE 135765EM498GW35IACT
SODIUM LAUROAMPHOACETATESLK428451LIACT
SUCROSEC151H8M554IACT
CLOTRIMAZOLEG07GZ97H65ACTIB
WATER059QF0KO0RIACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
POTASSIUM COCOYL GLYCINATEWZ70FUF22UIACT
SORBITOL506T60A25RIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
LAURIC ACID1160N9NU9UIACT
SULFUR70FD1KFU70IACT
PROPANEDIOL5965N8W85TIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
532931b2-0b32-f07a-e063-6294a90a2c262fc7544d-29be-1f07-e063-6294a90a5e442026-05-31Exact identifier
spl set id: 2fc7544d-29be-1f07-e063-6294a90a5e44

Reported adverse events (FAERS/openFDA)#

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