Drugplain

COOLING PAIN RELIEF 3 g/100mL

MENTHOL, CAMPHOR · GEL · CHEMCO CORPORATION

2 Recalls on Record
Plain English

COOLING PAIN RELIEF is a gel containing menthol, camphor at 3 g/100mL, taken topical. Manufactured by CHEMCO CORPORATION.

Key Facts

Brand Name
COOLING PAIN RELIEF
Generic Name
MENTHOL, CAMPHOR
NDC Code (Product)
49283-581
Manufacturer
CHEMCO CORPORATION
Strength
3 g/100mL
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
01/29/2026

Recall History

2 Recalls on Record
Class II07/11/2019

US Pharmaceuticals Inc.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

TerminatedVoluntary: Firm initiated
Class II10/24/2024

Unexo Life Sciences Private Limited

cGMP Deviations

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use92 reports
drug ineffective83 reports
dyspnoea82 reports
fatigue82 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

For the temporary relief of minor aches and pain associated with arthritis, simple backache, muscle strains, bruises, sprains, and cramps.

Dosage & Administration

Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Warnings

For external use only. Flammable-- Keep away from fire or flame. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

Frequently Asked Questions

What is COOLING PAIN RELIEF used for?

COOLING PAIN RELIEF contains MENTHOL, CAMPHOR. It is a gel taken topical. Consult your doctor for specific uses.

Is COOLING PAIN RELIEF a controlled substance?

COOLING PAIN RELIEF is not classified as a controlled substance by the DEA.

What is the generic name for COOLING PAIN RELIEF?

The generic name for COOLING PAIN RELIEF is MENTHOL, CAMPHOR. There are 10 other brand versions of MENTHOL, CAMPHOR.

What is the NDC code for COOLING PAIN RELIEF 3 g/100mL?

The NDC (National Drug Code) for COOLING PAIN RELIEF 3 g/100mL is 49283-581, listed by CHEMCO CORPORATION.

Product NDC

49283-581

Package NDC

49283-581-20

Other COOLING PAIN RELIEF Dosages

Other Menthol, Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)