FDA.reportPublic FDA data

Muscle Rub Pain Reliever Gel

Manufacturer
Universal Distribution Centre LLC
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:42:07

Label at a glance#

ProductMuscle Rub Pain Reliever Gel
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure11 sections

Indications and uses

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

Storage and handling

store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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 backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have redness over the affected area

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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 right away.

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

STORAGE AND HANDLING SECTION

store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

camphor, carbomer, DMDM hydantoin, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, water

Questions?

OTC - QUESTIONS SECTION

call 1-800-223-0182 (toll-free) or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelExtra Strength Muscle Rub

Pain Reliever Gel

Fast Penetrating

MENTHOL 2.5% TOPICAL ANALGESIC GEL


NET WT 1 OZ (35.4 g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
282805menthol 2.5 % Topical GelPSN4
282805menthol 0.025 MG/MG Topical GelSCD4
282805menthol 2.5 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52000-072-022025-07-29C16284748780-13b156c62-308b-fb37-e063-e6dba90a4e07Pain Reliever Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-072-01Muscle Rub Pain Reliever Gel35.4 g in 1 TUBEGEL35.44
52000-072-02Muscle Rub Pain Reliever Gel1 in 1 CARTONGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-072MUSCLE RUB PAIN RELIEVER GEL (MENTHOL, UNSPECIFIED FORM) GEL [UNIVERSAL DISTRIBUTION CENTRE LLC]4Current NDC, Legacy NDC, 2 package rows20241212_b9a563b6-7988-79df-e053-2995a90a752b.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52000-07252000-072-01, 52000-072-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ISOCETETH-20O020065R7ZIACT
ISOPROPYL ALCOHOLND2M416302IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Muscle Rub Pain Reliever GelMENTHOL, UNSPECIFIED FORMUniversal Distribution Centre LLC18536e21-afc3-8447-e063-6394a90aabae2025-10-30WarningsExact identifier
ndc (product): 52000-072
c56ff828-aac4-45ce-8871-7dc25850059db9a563b6-7988-79df-e053-2995a90a752b2024-12-03WarningsExact identifier
spl id: c56ff828-aac4-45ce-8871-7dc25850059d
spl set id: b9a563b6-7988-79df-e053-2995a90a752b

Reported adverse events (FAERS/openFDA)#

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