Penetral Roll-on

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: Penetral Roll-on
Generic name: CAPSAICIN 0.025%
Manufacturer: PureTek Corporation
Product type: HUMAN OTC DRUG
SPL set ID: 56204c03-8b15-a8b5-e063-6394a90a8189
SPL ID: 56204c9f-5dc1-a226-e063-6394a90ac8f1
Version: 1
Effective date: 2026-07-10
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 06:18:48

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		M017	openfda.application_number
brand name		Penetral Roll-on	openfda.brand_name
generic name		CAPSAICIN 0.025%	openfda.generic_name
manufacturer name		PureTek Corporation	openfda.manufacturer_name
ndc	package	59088-329-07	openfda.package_ndc
ndc	product	59088-329	openfda.product_ndc
ndc11	package	59088032907	derived:openfda.package_ndc
rxcui		199870	openfda.rxcui
spl id		56204c9f-5dc1-a226-e063-6394a90ac8f1	id
spl set id		56204c03-8b15-a8b5-e063-6394a90a8189	set_id
unii		UW86K581WY	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 wounds or damaged skin ■ with a heating pad or any source of heat ■ if you are allergic to capsicum or any ingredients of this product ■ do not bandage tightly When using this product ■ avoid contact with eyes and other mucous membranes. ■ do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Stop use and ask a doctor if ■ condition worsens, or if symptoms persist for more than 7 days or clears up and occurs again within a few days, discontinue use of this product and consult a doctor. ■ redness is present ■ irritation develops Keep out of reach of children. ■ if pregnant or breast-feeding, ask a doctor before use. ■ if swallowed, get medical help or contact Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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