Drugplain

Rugged Fit Pain Relief Roll On 2 g/100mL

Menthol, Methyl Salicylate · GEL · SYSTEM4BOOK LLC

No Recall History
Plain English

Rugged Fit Pain Relief Roll On is a gel containing menthol, methyl salicylate at 2 g/100mL, taken topical. Manufactured by SYSTEM4BOOK LLC.

Key Facts

Brand Name
Rugged Fit Pain Relief Roll On
Generic Name
Menthol, Methyl Salicylate
NDC Code (Product)
85826-041
Manufacturer
SYSTEM4BOOK LLC
Strength
2 g/100mL
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
06/27/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

dizziness2 reports
pruritus2 reports
application site dermatitis1 reports
arthritis1 reports
asthenia1 reports
back pain1 reports
blood glucose increased1 reports
burning sensation1 reports
cardiac failure congestive1 reports
confusional state1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Temporarily relieves the minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, sprains, and bruises.

Dosage & Administration

Adults and children 12 years of age or older: apply to affected area up to 3 to 4 times daily. Children under 12 years of age: consult a physician.

Warnings

For external use only. Do not use on children under 12 years of age, with a heating pad (may blister skin), on wounds or damaged skin. When using this product do not bandage tightly, avoid contact with the eyes or mucous membranes. Stop use and ask a doctor if excessive irritation develops, symptoms last more than 7 days or clear up and occur again within a few days, condition worsens.

Frequently Asked Questions

What is Rugged Fit Pain Relief Roll On used for?

Rugged Fit Pain Relief Roll On contains Menthol, Methyl Salicylate. It is a gel taken topical. Consult your doctor for specific uses.

Is Rugged Fit Pain Relief Roll On a controlled substance?

Rugged Fit Pain Relief Roll On is not classified as a controlled substance by the DEA.

What is the generic name for Rugged Fit Pain Relief Roll On?

The generic name for Rugged Fit Pain Relief Roll On is Menthol, Methyl Salicylate. There are 11 other brand versions of Menthol, Methyl Salicylate.

What is the NDC code for Rugged Fit Pain Relief Roll On 2 g/100mL?

The NDC (National Drug Code) for Rugged Fit Pain Relief Roll On 2 g/100mL is 85826-041, listed by SYSTEM4BOOK LLC.