RoyceDerm Tea Tree Oil Antifungal .spray.

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 Tea Tree Oil Antifungal .spray.
Generic name: CLOTRIMAZOLE 1%
Manufacturer: RoyceDerm LLC
Product type: HUMAN OTC DRUG
SPL set ID: 52da8be4-467c-c011-e063-6294a90a166f
SPL ID: 52da8be4-467d-c011-e063-6294a90a166f
Version: 1
Effective date: 2026-05-28
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:19:21

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 Tea Tree Oil Antifungal .spray.	openfda.brand_name
generic name		CLOTRIMAZOLE 1%	openfda.generic_name
manufacturer name		RoyceDerm LLC	openfda.manufacturer_name
ndc	package	85424-024-01	openfda.package_ndc
ndc	product	85424-024	openfda.product_ndc
ndc11	package	85424002401	derived:openfda.package_ndc
rxcui		358371	openfda.rxcui
spl id		52da8be4-467d-c011-e063-6294a90a166f	id
spl set id		52da8be4-467c-c011-e063-6294a90a166f	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 When using this product Avoid contact with the eye. Stop and ask a doctor if irritation occurs or ifthere is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot & righworm. Do not use on children under 2 of age except under the advice ad supervision of 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.