FDA.reportPublic FDA data

Arth Arrest

Manufacturer
Key 2 Health, Inc.
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:00:05

Label at a glance#

ProductArth Arrest
Active ingredientMETHYL NICOTINATE, CAPSAICIN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Methyl Nicotinate 0.5% Capsaicin 0.025 %

OTC - PURPOSE SECTION

Indications For the temporary relief of minor aches and pains of muscles and joints.

WARNINGS SECTION

FOR EXTERNAL USE ONLY Warnings: Use only as directed, Avoid contact with eyes. Do not apply to wounds or damaged skin. Do not bandage tightly. If condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. Please see outer box for additional warnings prior to use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.


DOSAGE & ADMINISTRATION SECTION

Directions: Adults and children 2 years of age and older. Apply to affected area no more than 3-4 times daily. Children under 2 years of age consult a physician.

INDICATIONS & USAGE SECTION

How to apply: Apply to a small area of the skin as a test for sensitivity at least 60 minutes prior to applying to a wide area.

INACTIVE INGREDIENT SECTION

Other Ingredients

Isopropyl Alcohol, Deionized Water, Neurocaine:(Lidocaine HCl, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Aloe Barbadensis Leaf (Aloe Vera) Gel, Arnica Montana Flower Extract, Ruta Graveolens (Rue) Extract, Chamomilla Recutita (Chamomile) Extract, Boswella Serrata Extract, Polysorbate-80, Fragrance).

OTC - QUESTIONS SECTION

Questions or comments Toll free 1-800-339-3301 www.Key2Health.com

Distributed by: Key2Health Inc., Tampa, Florida 33618


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Penetrating Pain Relief

Double Action Formula

With Neurocaine

ARTH ARREST

Net Wt. 3 oz (85gm)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arth ArrestArth Arrest

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1091943capsaicin 0.025 % / methylnicotinate 0.5 % Topical CreamPSN6
1091943capsaicin 0.25 MG/ML / methylnicotinate 5 MG/ML Topical CreamSCD6
1091943capsaicin 0.025 % / methylnicotinate 0.5 % Topical CreamSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NIACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76018-100-03Arth Arrest85 g in 1 BOTTLECREAM856

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76018-100ARTH ARREST (METHYL NICOTINATE, CAPSAICIN) CREAM [KEY 2 HEALTH, INC.]6Current NDC, Legacy NDC, 1 package rows20231112_495034ac-dbf5-4c55-906b-6ffcbcfd5bc2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZM3
METHYL NICOTINATEACTIVE INGREDIENT7B1AVU9DJN3
CAPSAICINACTIVE MOIETYS07O44R1ZM3
NIACINACTIVE MOIETY2679MF687A3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X3
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZ3
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE703
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163023
LAURETH-7INACTIVE INGREDIENTZ95S6G82013
LIDOCAINE HYDROCHLORIDEINACTIVE INGREDIENTV13007Z41A3
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)INACTIVE INGREDIENT0L414VCS5Y3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76018-10076018-100-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CHAMOMILEFGL3685T2XIACT
POLYSORBATE 806OZP39ZG8HIACT
METHYL NICOTINATE7B1AVU9DJNACTIB
CAPSAICINS07O44R1ZMACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / TOPICAL20 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YSHAMPOO / TOPICAL1 %w/wExact identifier — unii+route
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
14 equally ranked IID candidates
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YSHAMPOO / TOPICAL1 %w/wExact identifier — unii+route
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
14 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / TOPICAL20 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
14 equally ranked IID candidates

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
Arth ArrestMETHYL NICOTINATE, CAPSAICINKey 2 Health, Inc.495034ac-dbf5-4c55-906b-6ffcbcfd5bc22023-11-11WarningsExact identifier
ndc (package): 76018-100-03
ndc (product): 76018-100
ndc11 (package): 76018010003
spl id: 09e20d45-bfaf-e303-e063-6394a90a445f
spl set id: 495034ac-dbf5-4c55-906b-6ffcbcfd5bc2

Reported adverse events (FAERS/openFDA)#

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