Drugplain

4% MENTHOL COLD THERAPY 4 g/100g

Menthol · GEL · Universal Distribution Center LLC

No Recall History
Plain English

4% MENTHOL COLD THERAPY is a gel containing menthol at 4 g/100g, taken topical. Manufactured by Universal Distribution Center LLC.

Key Facts

Brand Name
4% MENTHOL COLD THERAPY
Generic Name
Menthol
NDC Code (Product)
52000-442
Manufacturer
Universal Distribution Center LLC
Strength
4 g/100g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
01/19/2026

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 • for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains • provides cooling pain relief

Dosage & Administration

Directions • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: do not use, consult a doctor • wash hands after use with cool water

Warnings

Warnings For external use only When using this product • avoid contact with eyes • do not apply to wounds or damaged skin • do not bandage tightly • do not use with heating pads or heating devices Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days Flammable: Keep away from excessive heat or open flame If pregnant or breastfeeding, 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 4% MENTHOL COLD THERAPY used for?

4% MENTHOL COLD THERAPY contains Menthol. It is a gel taken topical. Consult your doctor for specific uses.

Is 4% MENTHOL COLD THERAPY a controlled substance?

4% MENTHOL COLD THERAPY is not classified as a controlled substance by the DEA.

What is the generic name for 4% MENTHOL COLD THERAPY?

The generic name for 4% MENTHOL COLD THERAPY is Menthol. There are 12 other brand versions of Menthol.

What is the NDC code for 4% MENTHOL COLD THERAPY 4 g/100g?

The NDC (National Drug Code) for 4% MENTHOL COLD THERAPY 4 g/100g is 52000-442, listed by Universal Distribution Center LLC.