FDA.reportPublic FDA data

Soothanol X2

Manufacturer
NewMarket Health Products LLC | Vitality Works, Inc.
Effective date
2017-08-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:52:27

Label at a glance#

ProductSoothanol X2
Active ingredientCAPSAICIN, MENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Capsaicin 0.20%

Menthol 12%

OTC - PURPOSE SECTION

Purpose

Topical Analgesic

Topical Analgesic

INDICATIONS & USAGE SECTION

Uses for temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes or mucus membranes
  • do not bandage tighly
  • do not apply to wounds or damaged skin

OTC - STOP USE SECTION

Stop use and ask doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • excessive irritation of skin develops

PREGNANCY SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER SAFETY INFORMATION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years of age and older: wash hands and affected area with lukewarm water and apply 2-3 drops with fingertips not more than 3 to 4 times daily
  • children under 12 years of age: consult a physician
  • do not use otherwise than as directed

OTHER SAFETY INFORMATION

Other information

Store in a cool, dry place.

INACTIVE INGREDIENT SECTION

Inactive ingredients

arnica flower, calendula flower, dimethyl sulfoxide (DMSO), d-Limonene oil, emu oil (non-vegetarian), extra virgin olive oil, ginger root, methylsulfonylmethane (MSM), st. john's wort, wintergreen oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

North Star 

Nutritionals 

SOOTHANOL X2 

Pain Relieving Drops 

Net: 1 Fluid OZ/ 30 ML

SoothanolX2SoothanolX2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1540500capsaicin 0.2 % / menthol 12 % Topical SolutionPSN2
1540505SOOTHANOL X2 0.2 % / 12 % Topical SolutionPSN2
1540505capsaicin 2 MG/ML / menthol 120 MG/ML Topical Solution [Soothanol X2]SBD2
1540500capsaicin 2 MG/ML / menthol 120 MG/ML Topical SolutionSCD2
1540500capsaicin 0.2 % / menthol 12 % Topical SolutionSY2
1540505Soothanol X2 (capsaicin 0.2 % / menthol 12 % ) Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50972-766-012020-01-31C16284748780-19d75b9cf-dd1b-f424-e053-dadaa90a57ceSoothanol X2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50972-766-01Soothanol X228.3 g in 1 BOTTLE, DROPPERSOLUTION/ DROPS28.32
50972-766-01Soothanol X21 in 1 BOXSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50972-766SOOTHANOL X2 (CAPSAICIN AND MENTHOL) SOLUTION/ DROPS [NEWMARKET HEALTH PRODUCTS LLC]2Legacy NDC, 2 package rows20170911_29ea4b34-dff7-40de-82b4-9b2dd1eb32ca.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZM1
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
CAPSAICINACTIVE MOIETYS07O44R1ZM1
MENTHOLACTIVE MOIETYL7T10EIP3A1
ARNICA ANGUSTIFOLIA FLOWERINACTIVE INGREDIENTNG0U89QRD81
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FT1
DIMETHYL SULFOXIDEINACTIVE INGREDIENTYOW8V9698H1
EMU OILINACTIVE INGREDIENT344821WD611
GINGERINACTIVE INGREDIENTC5529G5JPQ1
LIMONENE, (+)-INACTIVE INGREDIENTGFD7C86Q1W1
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022Y1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
ST. JOHN'S WORTINACTIVE INGREDIENTUFH8805FKA1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50972-76650972-766-01

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
CAPSAICINS07O44R1ZMACTIB
MENTHOLL7T10EIP3AACTIB
ARNICA ANGUSTIFOLIA FLOWERNG0U89QRD8IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
LIMONENE, (+)-GFD7C86Q1WIACT
EMU OIL344821WD61IACT
OLIVE OIL6UYK2W1W1EIACT
GINGERC5529G5JPQIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ST. JOHN'S WORTUFH8805FKAIACT
METHYL SALICYLATELAV5U5022YIACT

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 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HLOTION / TOPICAL45.5 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUSNAExact identifier — unii candidate
4 equally ranked IID candidates
LIMONENE, (+)-LIMONENE, (+)-GFD7C86Q1WLOTION / TOPICAL10 %v/vExact identifier — unii candidate
3 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPASTE, DENTIFRICE / DENTAL1.1 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
LIMONENE, (+)-LIMONENE, (+)-GFD7C86Q1WTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
3 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
GINGERGINGERC5529G5JPQSYRUP / ORAL0.05 ml/5mlExact identifier — unii candidate
2 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HIMPLANT / SUBCUTANEOUS104 mgExact identifier — unii candidate
4 equally ranked IID candidates
LIMONENE, (+)-LIMONENE, (+)-GFD7C86Q1WGEL / TOPICAL10 mgExact identifier — unii candidate
3 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YCAPSULE / ORAL16 mgExact identifier — unii candidate
8 equally ranked IID candidates
GINGERGINGERC5529G5JPQELIXIR / ORAL10 mg/5mlExact identifier — unii candidate
2 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YLOZENGE / ORAL53 mgExact identifier — unii candidate
8 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YDOUCHE / VAGINAL0.05 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YTABLET / ORAL10 mgExact identifier — unii candidate
8 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HSOLUTION / TOPICAL8008 mgExact identifier — unii candidate
4 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
cc878010-66e4-4cd0-8282-33ef5142ff1029ea4b34-dff7-40de-82b4-9b2dd1eb32ca2017-08-31WarningsExact identifier
spl id: cc878010-66e4-4cd0-8282-33ef5142ff10
spl set id: 29ea4b34-dff7-40de-82b4-9b2dd1eb32ca

Reported adverse events (FAERS/openFDA)#

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