Drugplain

SOMBRA WARM THERAPY .03 g/g

MENTHOL CAMPHOR · GEL · SOMBRA COSMETICS INC.

No Recall History
Plain English

Sombra Warm Therapy is a topical gel containing menthol and camphor that you apply directly to your skin to help relieve minor aches and pains. This over-the-counter product works by creating a warming sensation to soothe sore muscles and joints.

Key Facts

Brand Name
SOMBRA WARM THERAPY
Generic Name
MENTHOL CAMPHOR
NDC Code (Product)
61577-3100
Manufacturer
SOMBRA COSMETICS INC.
Strength
.03 g/g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
04/10/2026

Recall History

No Recall History

Side Effects Reported to FDA

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

application site burn2 reports
chemical injury2 reports
application site infection1 reports
application site vesicles1 reports
blister1 reports
burning sensation1 reports
burns second degree1 reports
drug ineffective1 reports
impaired work ability1 reports
product quality issue1 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 SOMBRA WARM THERAPY used for?

Sombra Warm Therapy is a topical gel containing menthol and camphor that you apply directly to your skin to help relieve minor aches and pains. This over-the-counter product works by creating a warming sensation to soothe sore muscles and joints.

Is SOMBRA WARM THERAPY a controlled substance?

SOMBRA WARM THERAPY is not classified as a controlled substance by the DEA.

What is the generic name for SOMBRA WARM THERAPY?

The generic name for SOMBRA WARM THERAPY is MENTHOL CAMPHOR. There are 3 other brand versions of MENTHOL CAMPHOR.

What is the NDC code for SOMBRA WARM THERAPY .03 g/g?

The NDC (National Drug Code) for SOMBRA WARM THERAPY .03 g/g is 61577-3100, listed by SOMBRA COSMETICS INC..

Product NDC

61577-3100

Package NDC

61577-3100-1

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)