RoyceDerm CoolDefense Refreshing Shower Gel

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 CoolDefense Refreshing Shower Gel
Generic name: TOLNAFTATE 1.0%
Manufacturer: RoyceDerm LLC
Product type: HUMAN OTC DRUG
SPL set ID: 3b3216d6-8cc8-ea89-e063-6294a90ab691
SPL ID: 3b3216d6-8cc9-ea89-e063-6294a90ab691
Version: 1
Effective date: 2025-07-31
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:49:07

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 CoolDefense Refreshing Shower Gel	openfda.brand_name
generic name		TOLNAFTATE 1.0%	openfda.generic_name
manufacturer name		RoyceDerm LLC	openfda.manufacturer_name
ndc	package	85424-007-01	openfda.package_ndc
ndc	product	85424-007	openfda.product_ndc
ndc11	package	85424000701	derived:openfda.package_ndc
rxcui		2689792	openfda.rxcui
spl id		3b3216d6-8cc9-ea89-e063-6294a90ab691	id
spl set id		3b3216d6-8cc8-ea89-e063-6294a90ab691	set_id
unii		06KB629TKV	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 on children under 12 years of age. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use as directed. If pregnancy or breast feeding, ask a health professional before use. Keep out of reach of Children. In case of accidental ingestion, seek medical advice immediately or contact a poison control center right away.

Reported adverse events (FAERS/openFDA)#

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