Drugplain

Thera Plus Cold Therapy Pain Relieving Menthol 40 mg/mL

MENTHOL · GEL · Fourstar Group USA, Inc.

No Recall History
Plain English

Thera Plus Cold Therapy Pain Relieving Menthol is a gel containing menthol at 40 mg/mL, taken topical. Manufactured by Fourstar Group USA, Inc..

Key Facts

Brand Name
Thera Plus Cold Therapy Pain Relieving Menthol
Generic Name
MENTHOL
NDC Code (Product)
80684-101
Manufacturer
Fourstar Group USA, Inc.
Strength
40 mg/mL
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
02/01/2024

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

Dosage & Administration

Directions 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

Warnings

Warnings For external use only. Flammable: Keep away from excessive heat or open flame When using this product 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 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, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Thera Plus Cold Therapy Pain Relieving Menthol used for?

Thera Plus Cold Therapy Pain Relieving Menthol contains MENTHOL. It is a gel taken topical. Consult your doctor for specific uses.

Is Thera Plus Cold Therapy Pain Relieving Menthol a controlled substance?

Thera Plus Cold Therapy Pain Relieving Menthol is not classified as a controlled substance by the DEA.

What is the generic name for Thera Plus Cold Therapy Pain Relieving Menthol?

The generic name for Thera Plus Cold Therapy Pain Relieving Menthol is MENTHOL. There are 12 other brand versions of MENTHOL.

What is the NDC code for Thera Plus Cold Therapy Pain Relieving Menthol 40 mg/mL?

The NDC (National Drug Code) for Thera Plus Cold Therapy Pain Relieving Menthol 40 mg/mL is 80684-101, listed by Fourstar Group USA, Inc..