Dynarex Muscle Rub Cream

Manufacturer
Dynarex Corporation
Effective date
2017-06-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:51:39

Label at a glance#

ProductDynarex Muscle Rub Cream
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure10 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                                  Purpose

Menthol 10%                                        Topical analgesic

Methyl salicylate  15%  w/w                         Topical analgesic

Purpose

OTC - PURPOSE SECTION

Temporary relief of minor aches and pains of muscle joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Do not use other than directed.

Indications and Usage

INDICATIONS & USAGE SECTION

Uses

Temporary relief of minor aches and pains of sore muscles and joints.

Warnings

WARNINGS SECTION

For external use only.

  • Avoid contact with the eyes or mucous membranes.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use with heating pad or device.

Stop Use

OTC - STOP USE SECTION

Stop Use And Ask A Doctor If:

  • Condition worsens, or if symptoms persist for more than 7 days,
  • symptoms clear up and occur again in a few days
  • redness is present or excessive skin irritation develops

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Directions

  • Use only as directed
  • Adults and children 12 years of age and older: apply to the affected areas not more than 3 or 4 times daily.
  • Children under 12 years of age: Consult a physician.

Other Information

SPL UNCLASSIFIED SECTION

Store at 20° - 25°C (68°-77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, carbomer, cetyl alcohol, dimethicone, disodium EDTA, glycerin, glyceral monostearate, isopropyl myristate, methyparaben, phenoxyethanol, potassium cetyl phoshate, propylparaben, purified water, sodium hydroxide, stearic acid, titanium dioxide, polysorbate 20, Vitamin E, xanthan gum.

Principal Display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1135 GV.jpg

Dynarex CreamDynarex Cream

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67777-416-012020-01-31C16284748780-19d75b9d0-3256-f424-e053-dadaa90a57ceDynarex Muscle Rub Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-416-01Dynarex Muscle Rub Cream85 g in 1 TUBECREAM852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-416DYNAREX MUSCLE RUB CREAM (MENTHOL AND METHYL SALICYLATE) CREAM [DYNAREX CORPORATION]2Legacy NDC, 1 package rows20170616_7ca99d69-a463-4ac6-a35d-1b52f50912d4.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-41667777-416-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

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
e54b6cd6-dd30-4eb6-8324-303507b128a97ca99d69-a463-4ac6-a35d-1b52f50912d42017-06-15WarningsExact identifier
spl id: e54b6cd6-dd30-4eb6-8324-303507b128a9
spl set id: 7ca99d69-a463-4ac6-a35d-1b52f50912d4

Reported adverse events (FAERS/openFDA)#

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