FDA.reportPublic FDA data

Ultra Strenght Muscle Rub

Manufacturer
Inspec Solutions LLC.
Effective date
2019-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:24:32

Label at a glance#

ProductUltra Strenght Muscle Rub
Active ingredientMENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Menthol - 8.00%

Methyl Salicylate - 30.00%

OTC - PURPOSE SECTION

Purpose

Menthol - 8.00% .................................................. External Analgesic

Methyl Salicylate - 30.00% ................................. External Analgesic

INDICATIONS & USAGE SECTION

Uses Temporary relief for minor aches and pains of muscles and joints.

WARNINGS SECTION

Warnings

For external use only, Do not bandage tightly, apply to wounds or damaged skin or use with a heating pad.

OTC - STOP USE SECTION


Caution: Discontinue use if excessive irritation of skin develops, Avoid getting into eyes or mucous membranes, If condition worsens, or symptoms persist for more than 7 days or clear up and occur again within few days, or redness is present, or in conditions affecting children under 12 years of age, discontinue use and consult a physician immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental poisoning, if swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Use only as directed. Adults and children 12 years of age and older. Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: Ask a doctor.

INACTIVE INGREDIENT SECTION

DEA-Cetyl Phosphate

Glyceryl Stearate

Lanolin

Potassium Stearate

Stearic Acid

Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Muscle RubMuscle Rub

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72667-010-012021-01-29C16284748780-1ba0f9c33-1cc7-a910-e053-dadaa90a0b85Ultra Strength Muscle Rub

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72667-010ULTRA STRENGHT MUSCLE RUB (METHYL SALICYLATE, MENTHOL) CREAM [INSPEC SOLUTIONS LLC.]1Legacy NDC20190508_884eff89-be6d-510f-e053-2995a90ab5dd.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72667-01072667-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
POTASSIUM STEARATE17V812XK50IACT
STEARIC ACID4ELV7Z65APIACT
CETYL PHOSPHATEVT07D6X67OIACT
METHYL SALICYLATELAV5U5022YACTIB
WATER059QF0KO0RIACT
LANOLIN7EV65EAW6HIACT

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
4a1ba7f4-e74e-d9c4-e063-6294a90af823884eff89-be6d-510f-e053-2995a90ab5dd2026-02-05WarningsExact identifier
spl set id: 884eff89-be6d-510f-e053-2995a90ab5dd

Reported adverse events (FAERS/openFDA)#

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