RoyceDerm Tinea ANTIFUNGAL .soap.

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: RoyceDerm Tinea ANTIFUNGAL .soap.
Generic name: CLOTRIMAZOLE 1%
Manufacturer: RoyceDerm LLC
Product type: HUMAN OTC DRUG
SPL set ID: 4e889f2b-9ea1-b1a6-e063-6394a90a4654
SPL ID: 4e889f2b-9ea2-b1a6-e063-6394a90a4654
Version: 1
Effective date: 2026-04-03
Source export date: 2026-10-30
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/9abf0f8b126f8aad070e21ea702bfb5e39ce670b16ae57dd52e8877705d1bf5d/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:31:03

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M005	openfda.application_number
brand name		RoyceDerm Tinea ANTIFUNGAL .soap.	openfda.brand_name
generic name		CLOTRIMAZOLE 1%	openfda.generic_name
manufacturer name		RoyceDerm LLC	openfda.manufacturer_name
ndc	package	85424-022-01	openfda.package_ndc
ndc	product	85424-022	openfda.product_ndc
ndc11	package	85424002201	derived:openfda.package_ndc
rxcui		251267	openfda.rxcui
spl id		4e889f2b-9ea2-b1a6-e063-6394a90a4654	id
spl set id		4e889f2b-9ea1-b1a6-e063-6394a90a4654	set_id
unii		G07GZ97H65	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

For external use only. Avoid contact with the eye. 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. Do not use on children under 2 of age except under the advice and supervision fof a doctor. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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