Thera Plus Pain Relief Cream Arthritis and Muscle

Manufacturer: FOURSTAR GROUP USA, INC.
Effective date: 2025-02-28
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:56:24

Label at a glance#

ProductThera Plus Pain Relief Arthritis and Muscle

Active ingredientCAPSAICIN

Label structure8 sections

Indications and uses

for the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis atrains sprains bruises

Dosage and administration

Adults and children 18 years of age and older:apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application For best results,apply 3 to 4 times daily Children under 18 years of age: ask a doctor

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-639-3803

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.025%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains of muscles and joints associated with:

simple backache
arthritis
atrains
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 18 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

pregnant
breast feeding

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).

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 18 years of age and older:apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application
For best results,apply 3 to 4 times daily
Children under 18 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

cetostearyl alcohol,ethylparaben,glycerin,glyceryl monostearate,mineral oil,peregal O,petrolatum,purified water,stearic acid

Questions?

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer LabelInner Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198555	capsaicin 0.025 % Topical Cream	PSN	2
198555	capsaicin 0.25 MG/ML Topical Cream	SCD	2
198555	capsaicin 0.025 % Topical Cream	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
80684-138-00	Thera Plus Pain Relief Arthritis and Muscle	42.5 g in 1 TUBE	CREAM	42.5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80684-138	THERA PLUS PAIN RELIEF ARTHRITIS AND MUSCLE (CAPSAICIN) CREAM [FOURSTAR GROUP USA, INC.]	2	Current NDC, 1 package rows	20250302_dcff0a2d-7190-4b0c-abde-ba009b8ef005.zip

Products#

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

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

Thera Plus Pain Relief Arthritis and Muscle
CAPSAICIN
CETOSTEARYL ALCOHOL
ETHYLPARABEN
GLYCERIN
GLYCERYL MONOSTEARATE
MINERAL OIL
PETROLATUM
WATER
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80684-138	80684-138-00

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
Name	UNII	Kind
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
ETHYLPARABEN	14255EXE39	IACT
GLYCERIN	PDC6A3C0OX	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT
WATER	059QF0KO0R	IACT
STEARIC ACID	4ELV7Z65AP	IACT
CAPSAICIN	S07O44R1ZM	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 Pain Relief Arthritis and Muscle	CAPSAICIN	FOURSTAR GROUP USA, INC.	dcff0a2d-7190-4b0c-abde-ba009b8ef005	2025-02-28	Warnings	Exact identifier ndc (package): 80684-138-00 ndc (product): 80684-138 ndc11 (package): 80684013800 spl id: 2f34ac92-f455-28b1-e063-6294a90a6cfc spl set id: dcff0a2d-7190-4b0c-abde-ba009b8ef005

Reported adverse events (FAERS/openFDA)#

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