Tinactin

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: Tinactin
Generic name: TOLNAFTATE
Manufacturer: Bayer HealthCare LLC
Product type: HUMAN OTC DRUG
SPL set ID: bb878f31-2189-4427-aacf-5bce96d75978
SPL ID: 4526e2eb-ee8c-3ac4-e063-6394a90a133f
Version: 11
Effective date: 2025-12-04
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:19:08

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M005	openfda.application_number
brand name		Tinactin	openfda.brand_name
generic name		TOLNAFTATE	openfda.generic_name
manufacturer name		Bayer HealthCare LLC	openfda.manufacturer_name
ndc	package	11523-0165-3	openfda.package_ndc
ndc	product	11523-0165	openfda.product_ndc
ndc11	package	11523016503	derived:openfda.package_ndc
rxcui		209674	openfda.rxcui
rxcui		313421	openfda.rxcui
spl id		4526e2eb-ee8c-3ac4-e063-6394a90a133f	id
spl set id		bb878f31-2189-4427-aacf-5bce96d75978	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 Flammable: Do not use while smoking or near heat or flame Do not use on children under 2 years of age unless directed by a doctor. When using this product Avoid contact with the eyes use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks Keep out of reach of children. 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.