FDA.reportPublic FDA data

Muscle Rub Cream

Manufacturer
Trifecta Pharmaceuticals USA, LLC.
Effective date
2024-01-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:27

Label at a glance#

ProductMuscle Rub Cream
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure12 sections

Dosage and administration

Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age. consult a doctor Unless treating hands, wash hands thoroughly with soap and water immediately after use.

Storage and handling

Store at controlled room temperature 20º-25ºC (68º-77ºF) Questions ? Call 1-888-296-9067

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 15%

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

Warnings

WARNINGS SECTION

For external use only

Do not use:

  • On wounds or damaged, broken, (open) or irritated skin
  • With a heating pad

Ask a doctor before use if you are pregnant or breast feeding.

When using this product

  • Avoid contact with eyes or mucous membrane
  • Do not bandage tightly

Stop Use and ask a doctor

OTC - STOP USE SECTION

  • Conditions worsens or does not improve within 7 days
  • Symptoms clear up and occur again within a few days
  • Excessive skin irritation develops

A temporary burning sensation may occur upon application, but generally disappears in a few days

Keep out of the reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily.

Children under 12 years of age. consult a doctor

  • Unless treating hands, wash hands thoroughly with soap and water immediately after use.

Other Information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 20º-25ºC (68º-77ºF)

Questions ? Call 1-888-296-9067

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

Distributed By

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301

www.trifecta-pharma.com

Made in China

This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, a division of Johnson & Johnson consumer companies Inc. owner of the registered trademark BENGAY®.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

globe-muscle-rub-cream-3oz-CDER 6globe-muscle-rub-cream-3oz-CDER 6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN2
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD2
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY2
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-110-30Muscle Rub Cream1 in 1 BOXCREAM12
69396-110-30Muscle Rub Cream85 g in 1 TUBECREAM852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-110MUSCLE RUB CREAM (MENTHOL 10%, METHYL SALICYLATE 15%) CREAM [TRIFECTA PHARMACEUTICALS USA, LLC.]2Current NDC, Legacy NDC, 2 package rows20240103_e0a13344-5493-eb51-e053-2995a90a8183.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-110-30GM - Gram69396-1101f60379a-6c8c-4763-8eb2-1be25b6fcf5f12024-04-05

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-11069396-110-30

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
METHYL SALICYLATELAV5U5022YACTIB
POLYSORBATE 806OZP39ZG8HIACT
TROLAMINE9O3K93S3TKIACT
PROPYLPARABENZ8IX2SC1OHIACT
CARBOMER 9404Q93RCW27EIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERINPDC6A3C0OXIACT

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
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.e0a13344-5493-eb51-e053-2995a90a81832024-01-02WarningsExact identifier
ndc (package): 69396-110-30
ndc (product): 69396-110
ndc11 (package): 69396011030
spl id: 0df86c68-116f-515e-e063-6294a90a416a
spl set id: e0a13344-5493-eb51-e053-2995a90a8183

Reported adverse events (FAERS/openFDA)#

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