FDA.reportPublic FDA data

TOTAL MUSCLE RELIEF

Manufacturer
Electrostim Medical Services Inc. d/b/a EMSI | DIVERSIFIED MANUFACTURING CORP
Effective date
2019-02-27
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 sprains

Dosage and administration

ADULT AND CHILDREN 2 YEARS OF AGE AND OLDER: RUB A THIN FILM OVER AFFECTED AREAS NOT MORE THAN 4 TIMES DAILY. MASSAGE NOT NECESSARY. CHILDREN UNDER 2 YEARS OF AGE: CONSULT PHYSICIAN.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Menthol ---5.0%

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 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 develpes. 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 percist 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 2 YEARS OF AGE AND OLDER: RUB A THIN FILM OVER AFFECTED AREAS NOT MORE THAN 4 TIMES DAILY. MASSAGE NOT NECESSARY.

CHILDREN UNDER 2 YEARS OF AGE: CONSULT PHYSICIAN.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

PURIFIED WATER, Extract of Aloe Vera, Witch Hazel, Water Cress and Rosemary, Isopropanol, Glycerin, Coconut Oil, Sweet Almond Oil, Emu Oil, Carbomer, Sodium Hydroxide, Silica, F. D. & C Yellow #5, F. D.& C Blue #1, DMDM Hydantoin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOTAL MUSCLE RELIEF 3oz Roll OnTOTAL MUSCLE RELIEF 3oz Roll On

TOTAL MUSCLE RELIEF 4oz tubeTOTAL MUSCLE RELIEF 4oz tube

TOTAL MUSCLE RELIEF 16ozTOTAL MUSCLE RELIEF 16oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415975menthol 5 % Topical GelPSN1
415975menthol 0.05 MG/MG Topical GelSCD1
415975menthol 5 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50130-108-132022-01-28C16284748780-1d6a99b39-d1dc-a426-e053-dadaa90af4c25697ae1d-ead6-46a0-8074-d83bdc0f4605
50130-108-162022-01-28C16284748780-1d6a99b39-d1dc-a426-e053-dadaa90af4c25697ae1d-ead6-46a0-8074-d83bdc0f4605
50130-108-232022-01-28C16284748780-1d6a99b39-d1dc-a426-e053-dadaa90af4c25697ae1d-ead6-46a0-8074-d83bdc0f4605

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50130-108-13TOTAL MUSCLE RELIEF89 mL in 1 TUBEGEL891
50130-108-16TOTAL MUSCLE RELIEF473 mL in 1 BOTTLEGEL4731
50130-108-23TOTAL MUSCLE RELIEF89 mL in 1 BOTTLE, WITH APPLICATORGEL891

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50130-108TOTAL MUSCLE RELIEF (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1Legacy NDC, 3 package rows20190228_5697ae1d-ead6-46a0-8074-d83bdc0f4605.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50130-10850130-108-16, 50130-108-13, 50130-108-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
WITCH HAZEL101I4J0U34IACT
WATERCRESSK5877MW0LEIACT
ROSEMARYIJ67X351P9IACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
COCONUT OILQ9L0O73W7LIACT
ALMOND OIL66YXD4DKO9IACT
EMU OIL344821WD61IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
SODIUM HYDROXIDE55X04QC32IIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
DMDM HYDANTOINBYR0546TOWIACT

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
c5248e38-1fa5-4fba-85f8-af2c094066635697ae1d-ead6-46a0-8074-d83bdc0f46052019-02-27WarningsExact identifier
spl id: c5248e38-1fa5-4fba-85f8-af2c09406663
spl set id: 5697ae1d-ead6-46a0-8074-d83bdc0f4605

Reported adverse events (FAERS/openFDA)#

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