FDA.reportPublic FDA data

Thera Plus Cold Therapy Pain Relieving Gel Menthol

Manufacturer
Fourstar Group USA, Inc.
Effective date
2023-11-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:08:07

Label at a glance#

ProductThera Plus Cold Therapy Pain Relieving Menthol
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Dosage and administration

adults and children 2 years of age and older; rub a thin film over affected area not more than 3 to 4 times daily children under 2 years of age: consult a physician wash hands after use with cool water

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Gel

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Warnings

WARNINGS SECTION

For external use only.

Flammable:Keep away from excessive heat or open flame

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with the eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience pain, swelling or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older; rub a thin film over affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician
  • wash hands after use with cool water

Other information

SPL UNCLASSIFIED SECTION

  • store at 20° - 25°C (68° - 77°F)
  • store in a cool dry place away from direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, arctium lappa extract, arnica montana flower extract, blue1, boswellia serrata extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, methyl methacrylate crosspolymer, tocopheryl acetate, triethanoamine, yellow 5, water

Questions or comments?

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN2
415974menthol 0.04 MG/MG Topical GelSCD2
415974menthol 4 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-101-00Thera Plus Cold Therapy Pain Relieving Menthol74 mL in 1 BOTTLEGEL742

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-101THERA PLUS COLD THERAPY PAIN RELIEVING MENTHOL (MENTHOL) GEL [FOURSTAR GROUP USA, INC.]2Current NDC, 1 package rows20240201_0a462c91-5300-e282-e063-6394a90a4cc2.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80684-10180684-101-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
WATER059QF0KO0RIACT
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 Cold Therapy Pain Relieving MentholMENTHOLFourstar Group USA, Inc.0a462c91-5300-e282-e063-6394a90a4cc22023-11-27WarningsExact identifier
ndc (package): 80684-101-00
ndc (product): 80684-101
ndc11 (package): 80684010100
spl id: 0b23e32c-9248-271c-e063-6294a90a1f5c
spl set id: 0a462c91-5300-e282-e063-6394a90a4cc2

Reported adverse events (FAERS/openFDA)#

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