FDA.reportPublic FDA data

TOTAL MUSCLE RELIEF

Manufacturer
Electrostim Medical Services Inc. d/b/a EMSI | DIVERSIFIED MANUFACTURING CORP
Effective date
2019-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:39

Label at a glance#

ProductTOTAL MUSCLE RELIEF
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

Temporary relief from minor aches and pains of sore muscles and joints associated with arthrilis backaches strains and sprains

Dosage and administration

Adult and children 12 years of age and older: Spray on to the affected areas not more than four times daily. Massage not necessary. Children under 12 years of age: Consult physician.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol ---10.5%

Purpose

OTC - PURPOSE SECTION

Cooling Pain Relief

USES

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles and joints associated with arthrilis backaches strains and sprains

WARNINGS

WARNINGS SECTION

For external use only.
Flammable; Keep away from excessive heat or open-flame.
Ask doctor before use if you have: Sensitive skin.
When using this product: Avoid contact with the eyes or mucus membranes. Do not apply to wounds or damaged skin. Do not use with other ointments, creams, sprays or liniments. Do not apply to irritated skin of if excessive irritation develops. Do not bandage. Wash hand after use with cold water. Do not use heating pads or device. Store in a cool dry place. Stop use and ask doctor if: condition worsens or if symptoms persist for more than 7 days or clear up and recur.
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: if accidently ingested get medical help or contact Poison Control Center immediately

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adult and children 12 years of age and older: Spray on to the affected areas not more than four times daily. Massage not necessary.
Children under 12 years of age: Consult physician.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, Extract of Aloe Vera, Witch Hazel, Water Cress and Rosemary, Isopropanol, Glycerin, Polysorbate 20, Coconut Oil, Sweet Almond Oil, Emu Oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOTAL MUSCLE RELIEF 4oz spray v1.1TOTAL MUSCLE RELIEF 4oz spray v1.1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489073menthol 10.5 % Topical SprayPSN1
1489073menthol 105 MG/ML Topical SpraySCD1
1489073menthol 10.5 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50130-109-142022-01-28C16284748780-1d6a99b39-5020-a426-e053-dadaa90af4c2b6f8e297-75a0-4984-b2aa-5ab7d947654b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50130-109-14TOTAL MUSCLE RELIEF118 mL in 1 BOTTLE, SPRAYSPRAY1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50130-109TOTAL MUSCLE RELIEF (MENTHOL, CAMPHOR) SPRAY [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1Legacy NDC, 1 package rows20190228_b6f8e297-75a0-4984-b2aa-5ab7d947654b.zip

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
50130-10950130-109-14

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
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
WITCH HAZEL101I4J0U34IACT
WATERCRESSK5877MW0LEIACT
ROSEMARYIJ67X351P9IACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT
COCONUT OILQ9L0O73W7LIACT
ALMOND OIL66YXD4DKO9IACT
EMU OIL344821WD61IACT

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
8177a68a-892c-4bfa-8de8-d2d886bd5569b6f8e297-75a0-4984-b2aa-5ab7d947654b2019-02-16WarningsExact identifier
spl id: 8177a68a-892c-4bfa-8de8-d2d886bd5569
spl set id: b6f8e297-75a0-4984-b2aa-5ab7d947654b

Reported adverse events (FAERS/openFDA)#

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