FDA.reportPublic FDA data

MUSCLE RUB

Manufacturer
OL PHARMA TECH,LLC | OL PHARMA TECH,LLC (Drs. pharmacy)
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:52:13

Label at a glance#

ProductMUSCLE RUB
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure13 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

MENTHOL 2.5%

PURPOSE

OTC - PURPOSE SECTION

TOPICAL ANALGESIC

USES

INDICATIONS & USAGE SECTION

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

  • simple backaches
  • arthritis
  • strains
  • bruises
  • sprains

WARNINGS

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask your doctor

OTC - STOP USE SECTION

Stop use and ask your doctor if:

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

OTHER SAFETY INFORMATION

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION


vitamin E, propylene glycol, polysorbate 80, water, isopropyl alcohol, carbomer interpolymer type A, EDTA , methylparaben, propylparaben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • original strenghth
  • Topical analgesic muscle rubmuscle rub

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
282805menthol 2.5 % Topical GelPSN5
282805menthol 0.025 MG/MG Topical GelSCD5
282805menthol 2.5 % Topical GelSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80489-004-01MUSCLE RUB1 in 1 CARTONGEL15
80489-004-01MUSCLE RUB28.3 g in 1 TUBEGEL28.35
80489-004-02MUSCLE RUB49.6 g in 1 TUBEGEL49.65
80489-004-02MUSCLE RUB1 in 1 CARTONGEL15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80489-004MUSCLE RUB (MENTHOL) GEL [OL PHARMA TECH,LLC]5Current NDC, Legacy NDC, 4 package rows20250112_b22c7999-52d5-25c3-e053-2a95a90a01f5.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80489-00480489-004-01, 80489-004-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE DISODIUM7FLD91C86KIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
TROLAMINE9O3K93S3TKIACT
POLYSORBATE 806OZP39ZG8HIACT
METHYLPARABENA2I8C7HI9TIACT

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 RUBMENTHOLOL PHARMA TECH,LLCb22c7999-52d5-25c3-e053-2a95a90a01f52025-01-09WarningsExact identifier
ndc (package): 80489-004-02
ndc (package): 80489-004-01
ndc (product): 80489-004
ndc11 (package): 80489000402
ndc11 (package): 80489000401
spl id: 2b522348-ac98-f41f-e063-6294a90aef45
spl set id: b22c7999-52d5-25c3-e053-2a95a90a01f5

Reported adverse events (FAERS/openFDA)#

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