Thera plus Antifungal Clotrimazole

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: Thera plus Antifungal Clotrimazole
Generic name: CLOTRIMAZOLE
Manufacturer: FOURSTAR GROUP USA, INC.
Product type: HUMAN OTC DRUG
SPL set ID: 1265be99-8922-4b76-bd63-19bfb42c3896
SPL ID: 08a0ce90-0c11-15f4-e063-6294a90a6ca7
Version: 2
Effective date: 2023-10-26
Source export date: 2026-11-06
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/b00a73f24c6ff050408c570063640e3d80d1f71dfc9a165d1cf072a25659445a/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:00:55

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		Thera plus Antifungal Clotrimazole	openfda.brand_name
generic name		CLOTRIMAZOLE	openfda.generic_name
manufacturer name		FOURSTAR GROUP USA, INC.	openfda.manufacturer_name
ndc	package	80684-039-01	openfda.package_ndc
ndc	product	80684-039	openfda.product_ndc
ndc11	package	80684003901	derived:openfda.package_ndc
rxcui		309367	openfda.rxcui
spl id		08a0ce90-0c11-15f4-e063-6294a90a6ca7	id
spl set id		1265be99-8922-4b76-bd63-19bfb42c3896	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

Warnings For external use only. Do not use on children under 2 years of age except under the advice of a doctor. When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs. there is no improvement within 4 weeks (for athlete’s foot or ringworm) or within 2 weeks (for jock itch). If pregnant or breast-feeding, ask a health professional before use Keep this and all drugs out of the reach of children. if swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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