Icy Hot Pain Relieving Balm

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
Icy Hot Pain Relieving Balm
Generic name
MENTHOL AND METHYL SALICYLATE
Manufacturer
Chattem, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
40c8c02f-fa5f-4e80-81a0-48271fa6f94b
SPL ID
246dae26-59de-4caa-931f-6df0463a6acf
Version
17
Effective date
2026-06-12
Source export date
2026-11-06
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/2026-11-06/b0d9ca61dc485ebaf55e14a76d7d677668e40ef1e1978cdbcc4d73d58eba0b99/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:46:44
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

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

Warnings sections page 1 of 1 · 3 matching rows.

warnings

Warnings For external use only SEE INSIDE LABEL FOR COMPLETE DRUG FACTS Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. When using this product ■ use only as directed. Read and follow all directions and warnings on this label. ■ avoid contact with eyes and mucous membranes ■ rare cases of serious burns have been reported with products of this type ■ do not apply to wounds or damaged, broken or irritated skin ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ a transient burning sensation may occur upon application but generally disappears in several days ■ if severe burning sensation occurs, discontinue use immediately ■ do not expose the area treated with product to heat or direct sunlight Stop use and ask a doctor if condition worsens redness is present irritation develops 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 care professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

warnings

Warnings For external use only Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use When using this product ■ use only as directed. Read and follow all directions and warnings on this label. ■ avoid contact with eyes and mucous membranes ■ rare cases of serious burns have been reported with products of this type ■ do not apply to wounds or damaged, broken or irritated skin ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ do not use at the same time as other topical analgesics ■ a transient burning sensation may occur upon application but generally disappears in several days ■ if severe burning sensation occurs, discontinue use immediately ■ do not expose the area treated with product to heat or direct sunlight ■ avoid applying into skin folds Stop use and ask a doctor if ■ condition worsens ■ redness is present ■ irritation develops ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied 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.

warnings

Warnings For external use only Allergy alert: do not use if you are allergic to salicylates (including aspirin) unless directed by a doctor. Do not use ■ on wounds or on irritated or damaged skin ■ with a heating pad ■ at the same time as other topical analgesics When using this product ■ use only as directed ■ do not bandage tightly ■ avoid contact with eyes and mucous membranes ■ do not expose the area to local heat or to direct sunlight ■ rare cases of serious burns have been reported with products of this type ■ a transient burning sensation may occur upon application but generally disappears in several days ■ avoid applying into skin folds Stop use and ask a doctor if ■ condition worsens or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ redness is present or excessive skin irritation occurs ■ you experience severe burning pain, swelling, or blistering where the product was applied 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.