THERA PLUS PAIN RELIEF ARTHRITIS AND MUSCLE- capsaicin cream

Thera Plus Pain Relief Arthritis and Muscle by

Drug Labeling and Warnings

Thera Plus Pain Relief Arthritis and Muscle by is a Otc medication manufactured, distributed, or labeled by FOURSTAR GROUP USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Capsaicin 0.025%

Purpose

Topical analgesic

Uses

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

• simple backache
• arthritis 
• atrains
• sprains
• bruises

Warnings

For external use only.

Do not use

• 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

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

Ask a doctor before use if you have

• pregnant
• breast feeding

Stop use and ask a doctor if

• 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.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• 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

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

Inactive ingredients

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

Questions?

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

Package Labeling:

INGREDIENTS AND APPEARANCE

THERA PLUS PAIN RELIEF ARTHRITIS AND MUSCLE 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80684-138
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80684-138-00	42.5 g in 1 TUBE; Type 0: Not a Combination Product	02/28/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/28/2025

Labeler - FOURSTAR GROUP USA, INC. (140099503)