Label at a glance#

ProductThera Plus Cool and Heat Pain Relieving Gel Menthol

Active ingredientMENTHOL

Label structure8 sections

Indications and uses

For the temporarily relief of 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 generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat if necessary, but no more than 3 to 4 times daily • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER. Children 12 years or younger: ask a doctor

Contacts and useful links#

PhoneLabel contact1-800-639-3803

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Test on a small patch of skin before applying generously.

Flammable •keep away from fire or flame

When using this product

OTC - WHEN USING SECTION

• use only as directed • avoid contact with the eyes and mucous membranes • do not apply to wounds or damaged skin • do not
bandage tightly • do not use with heating pads or other heating devices • if redness is present, discontinue use and consult a doctor • if skin irritation occurs, discontinue use • a transient burning sensation may occur upon application but generally disappears in several days

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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 12 years of age and older: • apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat if necessary, but no more than 3 to 4 times daily • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER. Children 12 years or younger: ask a doctor

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

acrylates/c10-30 alkyl acrylate crosspolymer, capsaicin, glycerin, isopropyl myristate, propylene glycol, sd alcohol, triethanoamine, 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 PackageInner Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
253056	menthol 16 % Topical Gel	PSN	2
253056	menthol 0.16 MG/MG Topical Gel	SCD	2
253056	menthol 16 % Topical Gel	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80684-097-00	Thera Plus Cool and Heat Pain Relieving Gel Menthol	74 mL in 1 BOTTLE	LIQUID	74		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80684-097	THERA PLUS COOL AND HEAT PAIN RELIEVING GEL MENTHOL (MENTHOL) LIQUID [FOURSTAR GROUP USA, INC.]	2	Current NDC, 1 package rows	20240201_0a225714-ccb1-4676-e063-6294a90aeeb2.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Thera Plus Cool and Heat Pain Relieving Gel Menthol
MENTHOL
CAPSAICIN
GLYCERIN
ISOPROPYL MYRISTATE
PROPYLENE GLYCOL
TROLAMINE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80684-097	80684-097-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CAPSAICIN	S07O44R1ZM	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
TROLAMINE	9O3K93S3TK	IACT
WATER	059QF0KO0R	IACT
MENTHOL	L7T10EIP3A	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Thera Plus Cool and Heat Pain Relieving Gel Menthol	MENTHOL	Fourstar Group USA, Inc.	0a225714-ccb1-4676-e063-6294a90aeeb2	2023-11-30	Warnings	Exact identifier ndc (package): 80684-097-00 ndc (product): 80684-097 ndc11 (package): 80684009700 spl id: 0b61ea71-e589-bff5-e063-6394a90a2e50 spl set id: 0a225714-ccb1-4676-e063-6294a90aeeb2

Reported adverse events (FAERS/openFDA)#

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