Thera Plus Cool and Heat Pain Relieving Gel Menthol

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Thera Plus Cool and Heat Pain Relieving Gel Menthol
Generic name
MENTHOL
Manufacturer
Fourstar Group USA, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
0a225714-ccb1-4676-e063-6294a90aeeb2
SPL ID
0b61ea71-e589-bff5-e063-6394a90a2e50
Version
2
Effective date
2023-11-30
Source export date
2026-10-27
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-27/35717de05250cd386420cc8ede3b6010b48d18eea2af59afb0617fcabca634ec/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 20:04:08
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. Test on a small patch of skin before applying generously. Flammable • keep away from fire or flame When using this product • use only as directed • avoid contact with the eyes and mucous membranes • do not apply to wounds or damaged skin • do not bandage tightly • do not use with heating pads or other heating devices • if redness is present, discontinue use and consult a doctor • if skin irritation occurs, discontinue use • a transient burning sensation may occur upon application but generally disappears in several days 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.