FDA.reportPublic FDA data

Thera Plus Extra Strength Muscle Rub Topical Analgesic Gel

Manufacturer
FOURSTAR GROUP USA, INC.
Effective date
2025-08-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:09:58

Label at a glance#

ProductThera Plus Extra Strength Muscle Rub Topical Analgesic
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises

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 an arthritis-like condition

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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 (1-800-222-1222).

Direction

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

SPL UNCLASSIFIED SECTION

  • store at room temperature 68° - 72°F (20° - 22°C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-639-3803Weekdays 9 AM to 4 PM EST

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
282805menthol 2.5 % Topical GelPSN3
282805menthol 0.025 MG/MG Topical GelSCD3
282805menthol 2.5 % Topical GelSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-139-00Thera Plus Extra Strength Muscle Rub Topical Analgesic42.5 g in 1 TUBEGEL42.53

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80684-13980684-139-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
DMDM HYDANTOINBYR0546TOWIACT
ISOPROPYL ALCOHOLND2M416302IACT
PEG-40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
MENTHOLL7T10EIP3AACTIB

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
Thera Plus Extra Strength Muscle Rub Topical AnalgesicMENTHOLFOURSTAR GROUP USA, INC.8a3b6adf-afbb-4d77-a19b-a6514ebd3b502025-08-11WarningsExact identifier
ndc (package): 80684-139-00
ndc (product): 80684-139
ndc11 (package): 80684013900
spl id: 3c1ad278-b7b9-7859-e063-6294a90a528a
spl set id: 8a3b6adf-afbb-4d77-a19b-a6514ebd3b50

Reported adverse events (FAERS/openFDA)#

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