CR-371059 Tolnaftate 1% Cream

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: CR-371059 Tolnaftate 1% Cream
Generic name: CR-371059 TOLNAFTATE 1% CREAM
Manufacturer: Rugby Laboratories
Product type: HUMAN OTC DRUG
SPL set ID: b95a76ad-9b4c-692a-e053-2995a90abd1a
SPL ID: 446ea5a8-c23d-43a6-e063-6294a90ab9bf
Version: 6
Effective date: 2025-11-25
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 06:16:55

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		CR-371059 Tolnaftate 1% Cream	openfda.brand_name
generic name		CR-371059 TOLNAFTATE 1% CREAM	openfda.generic_name
manufacturer name		Rugby Laboratories	openfda.manufacturer_name
ndc	package	0536-1315-43	openfda.package_ndc
ndc	product	0536-1315	openfda.product_ndc
ndc11	package	00536131543	derived:openfda.package_ndc
rxcui		103951	openfda.rxcui
spl id		446ea5a8-c23d-43a6-e063-6294a90ab9bf	id
spl set id		b95a76ad-9b4c-692a-e053-2995a90abd1a	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 • This product is not effective on the scalp or nails When using this product Avoid contact with the eyes 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 Poisen Control Center (1-800-222-1222) right away • Do not use on children under 2 years of age except under the advice and supervision of a doctor

Reported adverse events (FAERS/openFDA)#

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