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Update Drug Listing - RoyceDerm Antifungal Bar-174

Manufacturer
RoyceDerm LLC
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:52:32

Label at a glance#

ProductRoyceDerm Antifungal Bar
Active ingredientCLOTRIMAZOLE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

OTC - PURPOSE SECTION

Anti-fungal

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 externaluse only.

OTC - DO NOT USE SECTION

on children under two years of age unless directed by a doctor.

OTC - WHEN USING SECTION

avoid contact withthe eyes.

OTC - ASK DOCTOR SECTION

irritation occurs-there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

lf swallowed,call poison control or seek medical help.

INDICATIONS & USAGE SECTION

  • Wash affected area well, rinse after 2 minutes. Dry 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 spaces between the toes; wear wellfitting, 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 dailyfor 2 weeks. lf condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.

OTHER SAFETY INFORMATION

store at room temperature and keep away from direct sunlight.

INACTIVE INGREDIENT SECTION

Sorbitol, Sucrose, Stearic Acid, Tallow, Cocamidopropyl Betaine, Propanediol,Glycerin, Sodium Laureth Sulfate, Water (Aqua), Lauric Acid, Sodium Hydroxide,Sodium Citrate, Charcoal Powder, Volcanic Ash, Melaleuca Alternifolia (Tea Tree)Leaf Oil, Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea) Butter,Mentha Arvensis Leaf Oil

RECENT MAJOR CHANGES SECTION

packagepackage

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antifungal BarAntifungal Bar

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251267clotrimazole 1 % Medicated Bar SoapPSN2
251267clotrimazole 0.01 MG/MG Medicated Bar SoapSCD2
251267clotrimazole 1 % Medicated Bar SoapSY2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850068161294GTIN-13: 0850068161294
EAN-13: 0850068161294
GTIN-12: 850068161294
UPC-A: 850068161294
GTIN storage (14 digits): 00850068161294		package.jpg

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-005-01RoyceDerm Antifungal Bar232 g in 1 CARTONSOAP2322
85424-005-02RoyceDerm Antifungal Bar226 g in 1 CARTONSOAP2262

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-00585424-005-01, 85424-005-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
SORBITOL506T60A25RIACT
STEARIC ACID4ELV7Z65APIACT
LAURIC ACID1160N9NU9UIACT
TALLOW98HPY76U4WIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
SUCROSEC151H8M554IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM HYDROXIDE55X04QC32IIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
SODIUM CITRATE1Q73Q2JULRIACT
CLOTRIMAZOLEG07GZ97H65ACTIB
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
AQUA059QF0KO0RIACT
CHARCOAL POWDER2P3VWU3H10IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT

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 Antifungal BarCLOTRIMAZOLERoyceDerm LLC3abdc4a8-58dd-5bd0-e063-6294a90a1bca2026-03-31WarningsExact identifier
ndc (package): 85424-005-02
ndc (package): 85424-005-01
ndc (product): 85424-005
ndc11 (package): 85424000502
ndc11 (package): 85424000501
spl id: 4e5e3a3a-ab41-10ca-e063-6294a90ace0e
spl set id: 3abdc4a8-58dd-5bd0-e063-6294a90a1bca

Reported adverse events (FAERS/openFDA)#

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