FDA label 216ef4b1-65cb-4cfe-ab1c-03b0713a2ee3

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)

SPL set ID
cf1001ec-b069-4d51-82e7-646a9583a43a
SPL ID
216ef4b1-65cb-4cfe-ab1c-03b0713a2ee3
Version
2
Effective date
2018-12-03
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:35:12

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only Do not apply to wounds or to damaged or irritated skin When using Hot Therapy • you may experience a burning sensation which is normal and related to the way the product works. With regular use, this sensation generally disappears within several days. • avoid contact with eyes. Do not get it on mucous membranes, into eyes or on contact lenses. If this occurs, rinse the affected area thoroughly with water. • do not apply immediately before or after activities such as bathing, swimming, sun bathing, or strenuous exercise • do not apply heat to the treated areas immediately before or after use • do not tightly wrap or bandage the treated area • avoid inhaling airborne material from dried residue. This can result in coughing, sneezing, tearing, throat or respiratory irritation. When using Cold Therapy • you may experience a cooling sensation which is normal and is related to the way the product works • avoid contact with eyes. Do not get it on mucous membranes, into eyes, or on contact lenses. If this occurs, rinse the affected area thoroughly with water. • do not apply heat to the treated areas immediately before or after use • do not tightly wrap or bandage the treated area 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, discontinue use of this product and consult a doctor • blistering occurs • difficulty breathing or swallowing occurs (Hot Therapy) • severe burning persists (Hot Therapy) • redness or irritation develops (Cold Therapy)

Reported adverse events (FAERS/openFDA)#

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