Drugplain

Thera Plus Extra Strength Muscle Rub Topical Analgesic 25 mg/g

MENTHOL · GEL · FOURSTAR GROUP USA, INC.

No Recall History
Plain English

Thera Plus Extra Strength Muscle Rub is a topical gel containing menthol that you can apply directly to your skin to help relieve muscle aches and pain. This over-the-counter product is available without a prescription.

Key Facts

Brand Name
Thera Plus Extra Strength Muscle Rub Topical Analgesic
Generic Name
MENTHOL
NDC Code (Product)
80684-139
Manufacturer
FOURSTAR GROUP USA, INC.
Strength
25 mg/g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
03/03/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use92 reports
drug ineffective82 reports
dyspnoea82 reports
fatigue81 reports
pain75 reports
pruritus72 reports
dizziness65 reports
cough64 reports
headache63 reports
drug hypersensitivity58 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Direction 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

Warnings

Warnings For external use only. Do not use 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 avoid contact with eyes and mucous membranes do not bandage tightly 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).

Frequently Asked Questions

What is Thera Plus Extra Strength Muscle Rub Topical Analgesic used for?

Thera Plus Extra Strength Muscle Rub is a topical gel containing menthol that you can apply directly to your skin to help relieve muscle aches and pain. This over-the-counter product is available without a prescription.

Is Thera Plus Extra Strength Muscle Rub Topical Analgesic a controlled substance?

Thera Plus Extra Strength Muscle Rub Topical Analgesic is not classified as a controlled substance by the DEA.

What is the generic name for Thera Plus Extra Strength Muscle Rub Topical Analgesic?

The generic name for Thera Plus Extra Strength Muscle Rub Topical Analgesic is MENTHOL. There are 12 other brand versions of MENTHOL.

What is the NDC code for Thera Plus Extra Strength Muscle Rub Topical Analgesic 25 mg/g?

The NDC (National Drug Code) for Thera Plus Extra Strength Muscle Rub Topical Analgesic 25 mg/g is 80684-139, listed by FOURSTAR GROUP USA, INC..