Penetrex(r) Arthritis Pain Relief

Manufacturer
Allure Labs
Effective date
2022-06-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:53

Label at a glance#

ProductPenetrex(r) Arthritis Pain Relief
Active ingredientCAPSAICIN
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Capsaicin 0.025%

OTC - PURPOSE SECTION

Purpose

Topical analgesic

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves minor pains of muscles and joints associated with arthritis,simple backache,muscle strains,bruises,sprains,cramps

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

on wounds, damaged, or irritated skin

with a heating pad

if you are alergic to capsicum or chili peppers

OTC - WHEN USING SECTION

When using this product

Read directions befbre using

use only as directed; read and follow all directions and warnings on this carton rare cases of serious bums have been reported with products of this type

do not bandage tightly or apply local heat (such as heating pads) to the area of use

avoid contact with eyes and mucous membranes

do not apply to wounds or damaged, broken or irritated skin

a transient burning sensation may occur upon application but generally disappears in several days

if severe burning occurs, discontinue use immediately

do not expose the area treated With product to heat or direct sunlight

do not use at the same time as other topical analgesics,

OTC - STOP USE SECTION

Stop use and ask a doctor if

condition worsens

redness is present

irritation develops

symptoms persist for more than 7 days or clear up and occur again within a few days

you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swalowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions:

Adults and children 18 years of age and older:

apply to affected area but no more than 3 to 4 times daily

massage onto painful area until thoroughly absorbed

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Children under 18 years of age: ask a doctor

OTHER SAFETY INFORMATION

If pregnant or breast-feeding, ask a health professional before use

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Water (Aqua),Helanthus Annuus (Sunflower) Seed Oil, Glycerin,GlycerylStearates, Amica Montana Flower Extract,

Cetearyl Alcohol,Ceteareth-20,PEG-100 Stearate, Butyrospermum Parkii (Shea) Buffer,Cetyl Esters,Ammonium Acryloyldimethyltaurate/VP Copolymer, Aloe Barbadensis Leaf Juice,Dimethicone, Ethoxydiglycol, Phenoxyethanol,

Methyl Gluceth-20,Menthe Piperita Oil,Camphor,Ethylhexylglycerin,Potassium Sorbate, Glucosamine HCI,Choline Bitartrate,

Pyridoxine HCL, Glycyrrhizinate Dipotassium, Methyl sulfonyl Methane,Disodium EDTA, Boswellia carterii oil,

Sodium Benzoate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopherol, Citric Acid,Beta-Sitosterol, Squalene.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ArthritispainreliefArthritispainrelief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198555capsaicin 0.025 % Topical CreamPSN1
198555capsaicin 0.25 MG/ML Topical CreamSCD1
198555capsaicin 0.025 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62742-4216-1Penetrex(r) Arthritis Pain Relief57 g in 1 TUBECREAM571
62742-4216-2Penetrex(r) Arthritis Pain Relief1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62742-4216PENETREX(R) ARTHRITIS PAIN RELIEF (CAPSAICIN) CREAM [ALLURE LABS]1Current NDC, Legacy NDC, 2 package rows20220623_e1e9dc90-247b-1e07-e053-2a95a90aec9d.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62742-421662742-4216-1, 62742-4216-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

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
Penetrex(r) Arthritis Pain ReliefCAPSAICINAllure Labse1e9dc90-247b-1e07-e053-2a95a90aec9d2022-06-20WarningsExact identifier
ndc (package): 62742-4216-2
ndc (package): 62742-4216-1
ndc (product): 62742-4216
ndc11 (package): 62742421602
ndc11 (package): 62742421601
spl id: e1e9dc90-247c-1e07-e053-2a95a90aec9d
spl set id: e1e9dc90-247b-1e07-e053-2a95a90aec9d

Reported adverse events (FAERS/openFDA)#

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