CLARUS Antifungal

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: CLARUS Antifungal
Generic name: TOLNAFTATE
Manufacturer: Clinical Therapeutic Solutions
Product type: HUMAN OTC DRUG
SPL set ID: 835c3c23-fc3c-404e-8e87-5a0176126730
SPL ID: 126eb818-7e35-3cce-e063-6294a90a5e69
Version: 1
Effective date: 2024-02-28
Source export date: 2026-11-06
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/39f3c0903357a80632a5484c9d6a804272f4b297080aa9c5a01a84db133f7a03/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:59:06

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		M	openfda.application_number
brand name		CLARUS Antifungal	openfda.brand_name
generic name		TOLNAFTATE	openfda.generic_name
manufacturer name		Clinical Therapeutic Solutions	openfda.manufacturer_name
ndc	package	44577-470-00	openfda.package_ndc
ndc	product	44577-470	openfda.product_ndc
ndc11	package	44577047000	derived:openfda.package_ndc
rxcui		103951	openfda.rxcui
spl id		126eb818-7e35-3cce-e063-6294a90a5e69	id
spl set id		835c3c23-fc3c-404e-8e87-5a0176126730	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

Warnings: For external use only. Avoid contact with the eyes. Do not use on children under 2 years of age unless directed by a physician. Stop use and ask physician if: When using for athlete's foot or ringworm: if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician. When using for prevention of athlete's foot: If irritation occurs, discontinue use and consult a physician. If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. In the case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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