FDA.reportPublic FDA data

Penetral ® Roll-on Gel Capsaicin 0.025%

Manufacturer
PureTek Corporation
Effective date
2026-07-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-18 05:10:27

Label at a glance#

ProductPenetral Roll-on
Active ingredientCAPSICUM OLEORESIN
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises, and sprains. ■ Provides warming pain relief.

Dosage and administration

■ Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily ■ Children under 2 years of age: do not use, consult a doctor ■ Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsicum Oleoresin (Containing Capsaicin 0.025%)

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises, and sprains.

■ Provides warming pain relief.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

■ 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

SPL UNCLASSIFIED SECTION

■ 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

OTC - STOP USE SECTION

■ 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

■ if pregnant or breast-feeding, ask a doctor before use.

■ if swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

■ Children under 2 years of age: do not use, consult a doctor

■ Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

Other Information

SPL UNCLASSIFIED SECTION

■ store at controlled room temperature 20° to 25°C (68° to 77°F) ■ store in a clean, dry place away from sunlight ■ protect from freezing ■ avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Ethyl Alcohol, Ethyl Menthane Carboxamide, Glycerin, Hydrolyzed Corn Starch Octenylsuccinate, Lauryl Laurate, Linum Usitatissimum (Flax) Seed Oil, Mentha Piperita (Peppermint) Oil, Menthyl Lactate, Methyl Diisopropyl Propionamide, Phenoxyethanol, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica, Sodium Hydroxide, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 1-877-921-7873

Drug FactsDrug Facts

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130359088329078GTIN-13: 0359088329078
EAN-13: 0359088329078
GTIN-12: 359088329078
UPC-A: 359088329078
GTIN storage (14 digits): 00359088329078		Drug Facts Penetral.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-32959088-329-07

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM HYDROXIDE55X04QC32IIACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TIACT
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL8LGU7VM393IACT
ETHYL MENTHANE CARBOXAMIDE6S7S02945HIACT
GLYCERINPDC6A3C0OXIACT
MENTHA PIPERITA (PEPPERMINT) OILAV092KU4JHIACT
LAURYL LAURATEGPW77G0937IACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
LINUM USITATISSIMUM (LINSEED) SEED OIL84XB4DV00WIACT
METHYL DIISOPROPYL PROPIONAMIDE6QOP5A9489IACT
PPG-2 HYDROXYETHYL COCAMIDE34N07GUJ3XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPSICUM OLEORESINUW86K581WYACTIR
SILICAETJ7Z6XBU4IACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Penetral Roll-onCAPSAICIN 0.025%PureTek Corporation56204c03-8b15-a8b5-e063-6394a90a81892026-07-10WarningsExact identifier
ndc (package): 59088-329-07
ndc (product): 59088-329
ndc11 (package): 59088032907
spl id: 56204c9f-5dc1-a226-e063-6394a90ac8f1
spl set id: 56204c03-8b15-a8b5-e063-6394a90a8189

Reported adverse events (FAERS/openFDA)#

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