FDA.reportPublic FDA data

Arth RX Topical Analgesic

Manufacturer
HCD Sales
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:59:04

Label at a glance#

ProductArth RX Topical Analgesic
Active ingredientMETHYL NICOTINATE, CAPSAICIN
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                  Purpose     Methyl nicotinate 0.5%          External Analgesic Capsaicin 0.025 %                External Analgesic


OTC - PURPOSE SECTION

Uses: Temporarily relieves minor aches and pains of muscles and joints due to:

- Arthritis - Strains - Sprains

WARNINGS SECTION

WARNINGS

FOR EXTERNAL USE ONLY

INDICATIONS & USAGE SECTION

When Using This Product

- Avoid contact with eyes - Do not apply to wounds or damaged skin - Do not bandage tightly


OTC - STOP USE SECTION

Stop use and ask doctor if

-  Condition worsens - Excessive irritation of the skin develops - Pain persists for more than 7 days - Symptoms clear up and occur again within a few days



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 apply to affected area no more than 3-4 times daily - Children under 18 consult a physician - Apply to small area of the skin as test for sensitivity at least 60 minutes prior to applying to wide area.



INACTIVE INGREDIENT SECTION

Inactive Ingredients

Isopropanol, water, extracts of arnica and rue, polyacrylamide, C 13-14 isoparaffin. tween 80, laureth-7, boswellia, extract of chamomile, aloe, fragrance.

OTC - QUESTIONS SECTION

Questions or comments

Toll free 1-800-729-8446

DESCRIPTION SECTION

Products containing capsaicin may cause a burning, stinging or tingling sensation where applied. This is a natural reaction and varies with each individual usually decreasing or disappearing after continued use. Please read package insert prior to use. ..........  may be removed from the test area by wiping or olive oil.

Distributed by: HCD sales, Inc, Tampa, FL 33549 www.hcdsales.com



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

arth.Rx  TOPICAL ANALGESIC  ARTHRITIS PAIN RELIEF  PENETRATING PAIN RELIEF, DOUBLE ACTION FORMULA WITH DOCTOR RECOMMENDED CAPSAICIN NEW WT 3 OZ (85 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arth RX Topical AnalgesicArth RX Topical Analgesic

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094383Arth-Rx Topical Analgesic (capsaicin 0.025 % / methyl nicotinate 0.5 % ) Topical LotionPSN5
1094379capsaicin 0.025 % / methylnicotinate 0.5 % Topical LotionPSN5
1094383capsaicin 0.25 MG/ML / methylnicotinate 5 MG/ML Topical Lotion [Arth-RX]SBD5
1094379capsaicin 0.25 MG/ML / methylnicotinate 5 MG/ML Topical LotionSCD5
1094383Arth-Rx Topical Analgesic (capsaicin 0.025 % / methyl nicotinate 0.5 % ) Topical LotionSY5
1094379capsaicin 0.025 % / methylnicotinate 0.5 % Topical LotionSY5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
0a5e5249-329b-0cff-e714-77159f193a87Product 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
76069-100-03Arth RX Topical Analgesic85 g in 1 BOTTLELOTION855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76069-100ARTH RX TOPICAL ANALGESIC (METHYL NICOTINATE, CAPSAICIN) LOTION [HCD SALES]5Current NDC, Legacy NDC, 1 package rows20231106_a7b3b9b4-b1c4-4e51-8e3a-c84f64c75609.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZM2
METHYL NICOTINATEACTIVE INGREDIENT7B1AVU9DJN2
CAPSAICINACTIVE MOIETYS07O44R1ZM2
METHYL NICOTINATEACTIVE MOIETY7B1AVU9DJN2
ALOEINACTIVE INGREDIENTV5VD430YW92
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE702
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163022
LAURETH-7INACTIVE INGREDIENTZ95S6G82012
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)INACTIVE INGREDIENT0L414VCS5Y2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76069-10076069-100-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
POLYSORBATE 806OZP39ZG8HIACT
LAURETH-7Z95S6G8201IACT
ALOEV5VD430YW9IACT
METHYL NICOTINATE7B1AVU9DJNACTIB
CAPSAICINS07O44R1ZMACTIB

Source Document#

Source XML · Source PDF

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 ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 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
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii+route+dosage form
2 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
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 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 ALCOHOLND2M416302GEL / TOPICAL75 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 RX Topical AnalgesicMETHYL NICOTINATE, CAPSAICINHCD Salesa7b3b9b4-b1c4-4e51-8e3a-c84f64c756092023-11-06WarningsExact identifier
ndc (package): 76069-100-03
ndc (product): 76069-100
ndc11 (package): 76069010003
spl id: 0975eb87-fa94-1621-e063-6394a90a9880
spl set id: a7b3b9b4-b1c4-4e51-8e3a-c84f64c75609

Reported adverse events (FAERS/openFDA)#

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