Drugplain

SORE NO MORE COOL THERAPY .06 g/g

MENTHOL · GEL · SOMBRA COSMETICS INC.

No Recall History
Plain English

Sore No More Cool Therapy is a topical gel containing menthol that you apply directly to the skin to help relieve minor aches and pains. This over-the-counter product works by creating a cooling sensation on the affected area.

Key Facts

Brand Name
SORE NO MORE COOL THERAPY
Generic Name
MENTHOL
NDC Code (Product)
61577-3235
Manufacturer
SOMBRA COSMETICS INC.
Strength
.06 g/g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
06/14/2016

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: arthritis, simple backaches

Dosage & Administration

Directions adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age : consult a doctor.

Warnings

Warnings For external use only . Do not use on wounds or damaged skin. When using this product : avoid bandaging tightly, avoid contact with eyes, keep out of reach of children . Stop use and ask doctor if : condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

Frequently Asked Questions

What is SORE NO MORE COOL THERAPY used for?

Sore No More Cool Therapy is a topical gel containing menthol that you apply directly to the skin to help relieve minor aches and pains. This over-the-counter product works by creating a cooling sensation on the affected area.

Is SORE NO MORE COOL THERAPY a controlled substance?

SORE NO MORE COOL THERAPY is not classified as a controlled substance by the DEA.

What is the generic name for SORE NO MORE COOL THERAPY?

The generic name for SORE NO MORE COOL THERAPY is MENTHOL. There are 12 other brand versions of MENTHOL.

What is the NDC code for SORE NO MORE COOL THERAPY .06 g/g?

The NDC (National Drug Code) for SORE NO MORE COOL THERAPY .06 g/g is 61577-3235, listed by SOMBRA COSMETICS INC..