Clotrimazole (Topical Solution), 1%

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: Clotrimazole (Topical Solution), 1%
Generic name: CLOTRIMAZOLE
Manufacturer: Puro Pharma Inc.
Product type: HUMAN OTC DRUG
SPL set ID: cb424fa8-3ed5-45cd-b03f-64675584b34e
SPL ID: 46f2ddcb-401f-9ed7-e063-6394a90a7a63
Version: 2
Effective date: 2025-12-27
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 05:49:02

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		Clotrimazole (Topical Solution), 1%	openfda.brand_name
generic name		CLOTRIMAZOLE	openfda.generic_name
manufacturer name		Puro Pharma Inc.	openfda.manufacturer_name
ndc	package	83474-003-34	openfda.package_ndc
ndc	product	83474-003	openfda.product_ndc
ndc11	package	83474000334	derived:openfda.package_ndc
rxcui		309370	openfda.rxcui
spl id		46f2ddcb-401f-9ed7-e063-6394a90a7a63	id
spl set id		cb424fa8-3ed5-45cd-b03f-64675584b34e	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. Ask a doctor before use • on children under 2 years of age 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 and ringworm) or 2 weeks (for jock itch) 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.