Drugplain

DIRT Pain Relieving Gel 40 mg/mL

MENTHOL · GEL · PURIVITAE, LLC

No Recall History
Plain English

DIRT Pain Relieving Gel is a gel containing menthol at 40 mg/mL, taken topical. Manufactured by PURIVITAE, LLC.

Key Facts

Brand Name
DIRT Pain Relieving Gel
Generic Name
MENTHOL
NDC Code (Product)
83067-363
Manufacturer
PURIVITAE, LLC
Strength
40 mg/mL
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
10/03/2022

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 arthritis, simple back aches, strains, bruises, and sprains.

Dosage & Administration

Directions: Adults and children over 12 years of age: Children 12 years or younger: ask a doctor apply generously to affected areas rub into affected area until absorbed into the skin repeat as necessary, but no more than 4 times daily

Warnings

Warnings: For external use only Do not use on damaged or brokin skin. When using this product Avoid contact with the eyes. Do not bandage tightly. Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and 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 If pregnant or breast-feeding, ask a health professional before use

Frequently Asked Questions

What is DIRT Pain Relieving Gel used for?

DIRT Pain Relieving Gel contains MENTHOL. It is a gel taken topical. Consult your doctor for specific uses.

Is DIRT Pain Relieving Gel a controlled substance?

DIRT Pain Relieving Gel is not classified as a controlled substance by the DEA.

What is the generic name for DIRT Pain Relieving Gel?

The generic name for DIRT Pain Relieving Gel is MENTHOL. There are 12 other brand versions of MENTHOL.

What is the NDC code for DIRT Pain Relieving Gel 40 mg/mL?

The NDC (National Drug Code) for DIRT Pain Relieving Gel 40 mg/mL is 83067-363, listed by PURIVITAE, LLC.