FDA.reportPublic FDA data

ECM Pain Relief

Manufacturer
East Coast Medicinals
Effective date
2022-12-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:18:50

Label at a glance#

ProductECM Pain Relief
Active ingredientARNICA MONTANA, METHYL SALICYLATE, MENTHOL
Label structure7 sections

Indications and uses

Temporary relief of aches and pains associated with: Arthritis, Carpal Tunnel, Swelling, Sprains, Bruising, Inflammation Dosage: Apply to affected area 1 to 4 times daily, or as needed. Keep out of reach of children.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana (1%)................................ Topical Analgesic

Menthol (>1%).................................................. Topical Analgesic

Methyl Salicylate (>1%) ................................ Topical Analgesic

OTC - PURPOSE SECTION

Uses

DOSAGE FORMS & STRENGTHS SECTION

Temporary relief of aches and pains associated with: Arthritis, Carpal Tunnel, Swelling, Sprains, Bruising, Inflammation

DOSAGE & ADMINISTRATION SECTION

Dosage: Apply to affected area 1 to 4 times daily, or as needed.

Keep out of reach of children.

WARNINGS SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

Stop Use and Consult a Doctor if: Condition worsens, Symptoms last for more than 7 days, condition clears up but occurs again in a few days, rash or irritation occurs.

OTC - WHEN USING SECTION

For external use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep pout of reach of children

PREGNANCY SECTION

If Pregnant or Breast-feeding: Consult a health profesional before use

INDICATIONS & USAGE SECTION

Dosage: Apply to affected area 1 to 4 times daily, or as needed.

OTHER SAFETY INFORMATION

Store at 66-92 Degrees Fahrenheit. Avoid direct sunlight.

INACTIVE INGREDIENT SECTION

Shea Butter, Jojoba Oil, Beeswax, Coconut Oil, Water, Alpha Tocopherol, Magnesium Chloride, Cannabidiol Oil, Maranta Arrundinacea Root Powder

Front Of Jar

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ECM Pain Releif LabelECM Pain Releif Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82108-113-022024-01-30C16284748780-11030e365-2341-111a-e063-dadaa90a10e2East Coast Pain Releif

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82108-113-02ECM Pain Relief170.96 g in 1 JARCREAM170.961

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82108-113ECM PAIN RELIEF (MENTHOL, METHYL SALICYLATE, ARNICA) CREAM [EAST COAST MEDICINALS]1Legacy NDC, 1 package rows20221212_ef553a42-e76f-e852-e053-2995a90aa36e.zip

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
82108-11382108-113-02

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
WATER059QF0KO0RIACT
ARNICA MONTANAO80TY208ZWACTIB
COCONUT OILQ9L0O73W7LIACT
METHYL SALICYLATELAV5U5022YACTIB
PEG-8 BEESWAX3C1QUF1TIRIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
SHEA BUTTERK49155WL9YIACT
MENTHOLL7T10EIP3AACTIB
CANNABIDIOL19GBJ60SN5IACT
JOJOBA OIL724GKU717MIACT
MARANTA ARUNDINACEA ROOTFVN346W31AIACT

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
ef553a42-e770-e852-e053-2995a90aa36eef553a42-e76f-e852-e053-2995a90aa36e2022-12-08WarningsExact identifier
spl id: ef553a42-e770-e852-e053-2995a90aa36e
spl set id: ef553a42-e76f-e852-e053-2995a90aa36e