Tinea Versicolor Treatment Kit

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: Tinea Versicolor Treatment Kit
Generic name: CLOTRIMAZOLE
Manufacturer: Beautivity LLC
Product type: HUMAN OTC DRUG
SPL set ID: 3361d9a2-daf6-7749-e063-6294a90a3653
SPL ID: 5566dc99-c9bf-82de-e063-6294a90a45e5
Version: 3
Effective date: 2026-06-29
Source export date: 2026-09-28
Source partition: 14
Source file: https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:40:10

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M005	openfda.application_number
brand name		Tinea Versicolor Treatment Kit	openfda.brand_name
generic name		CLOTRIMAZOLE	openfda.generic_name
manufacturer name		Beautivity LLC	openfda.manufacturer_name
ndc	package	85398-002-01	openfda.package_ndc
ndc	package	85398-004-01	openfda.package_ndc
ndc	package	85398-003-01	openfda.package_ndc
ndc	product	85398-004	openfda.product_ndc
ndc11	package	85398000401	derived:openfda.package_ndc
ndc11	package	85398000301	derived:openfda.package_ndc
ndc11	package	85398000201	derived:openfda.package_ndc
rxcui		309367	openfda.rxcui
rxcui		251267	openfda.rxcui
spl id		5566dc99-c9bf-82de-e063-6294a90a45e5	id
spl set id		3361d9a2-daf6-7749-e063-6294a90a3653	set_id

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 Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with eyes, If contact occurs, rinse thoroughly with water. Stop use and ask doctor if irritation occurs or if there is no improvement within 2 weeks. keep out of reach of children. If swallowed, get medical help or contact a Posion Control enter right away.

Reported adverse events (FAERS/openFDA)#

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