FDA.reportPublic FDA data

Ultra Strength Muscle Rub

Manufacturer
The Mentholatum Company
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:11

Label at a glance#

ProductUltra Strength Muscle Rub
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Dosage and administration

adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 4%

Menthol 10%

Methyl salicylate 30%

Purpose

OTC - PURPOSE SECTION

Camphor - Topical analgesic

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not get into eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with a heating pad or apply external heat

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, carbomer 940, cocos nucifera (coconut) oil, edetate disodium, glyceryl stearate, isopropyl myristate, lanolin, mineral oil, polysorbate 60, purified water, sodium lauryl sulfate, stearic acid, trolamine, vitamin E

Questions?

OTC - QUESTIONS SECTION

Call 1-877-636-2677 MON - FRI 9 AM to 5 PM (EST)

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ultra Strength Muscle Rub
Ultra Strength Muscle Rub

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamPSN4
283083camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD4
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-6000-12023-02-07C16284748780-1f386c64a-0a5c-0266-e053-dadaa90a7c1aDrug Facts
10742-6000-12023-01-30C16284748780-1f386c64a-0a5c-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-6000-1Ultra Strength Muscle Rub113 g in 1 TUBECREAM1134
10742-6000-1Ultra Strength Muscle Rub1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-6000ULTRA STRENGTH MUSCLE RUB (CAMPHOR, MENTHOL, METHYL SALICYLATE) CREAM [THE MENTHOLATUM COMPANY]4Current NDC, Legacy NDC, 2 package rows20241219_32b64985-0e2f-49ee-9840-946d7279fee7.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-600010742-6000-1

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
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
COCONUT OILQ9L0O73W7LIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LANOLIN7EV65EAW6HIACT
MINERAL OILT5L8T28FGPIACT
POLYSORBATE 60CAL22UVI4MIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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
Ultra Strength Muscle RubCAMPHOR, MENTHOL, METHYL SALICYLATEThe Mentholatum Company32b64985-0e2f-49ee-9840-946d7279fee72024-12-17WarningsExact identifier
ndc (package): 10742-6000-1
ndc (product): 10742-6000
ndc11 (package): 10742600001
spl id: 2978aff0-b45d-d773-e063-6294a90a4fc1
spl set id: 32b64985-0e2f-49ee-9840-946d7279fee7

Reported adverse events (FAERS/openFDA)#

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