FDA.reportPublic FDA data

Icy Hot Pro Pain Massaging Balm

Manufacturer
Chattem, Inc.
Effective date
2026-02-27
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:48:40

Label at a glance#

ProductIcy Hot Pro Pain Massaging Balm
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure8 sections

Indications and uses

temporarily relieves minor aches and pains of muscles and joints associated with: arthritis simple backache strains sprains bruises

Dosage and administration

adults and children 12 years of age and older: massage into affected area using the no-mess balm not more than 3 to 4 times daily wash hands thoroughly with soap and water if product comes in contact with hands children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Icy Hot PRO Pain Relief Massaging Balm

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphor 11% 

Menthol 16%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on wounds or on irritated or damaged skin
  • with a heating pad

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not bandage tightly
  • avoid contact with eyes and mucous membranes
  • do not expose the area to local heat or 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

This product is not a toy or intended for use by children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older:
    • massage into affected area using the no-mess balm not more than 3 to 4 times daily
    • wash hands thoroughly with soap and water if product comes in contact with hands

  • children under 12 years of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

prunus amygdalus dulcis (sweet almond) oil, helianthus annuus (sunflower) seed wax, theobroma cacao (cocoa) seed butter, cocos nucifera (coconut) oil, persea gratissima (avocado) oil, hydrogenated vegetable oil, copernicia cerifera (carnauba) wax, synthetic beeswax, citrus paradisi (grapefruit) peel oil, eucalyptus globulus leaf oil, mentha piperita (peppermint) oil, mentha viridis (spearmint) leaf oil

Close cap tightly after use. Keep carton as it contains important information.

Keep carton as it contains important information. 

     

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ICY HOT
ADVANCED PRO
MASSAGING BALM
PAIN RELIEF
NET WT 1.25 OZ (35 g)

ICY HOT ADVANCED PRO MASSAGING BALM PAIN RELIEF NET WT 1.25 OZ (35 g)ICY HOT ADVANCED PRO MASSAGING BALM PAIN RELIEF NET WT 1.25 OZ (35 g)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0790-0Icy Hot Pro Pain Massaging Balm35 g in 1 BOTTLECREAM356
41167-0790-0Icy Hot Pro Pain Massaging Balm1 in 1 CARTONCREAM16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-079041167-0790-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
ALMOND OIL66YXD4DKO9IACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
COCOA BUTTER512OYT1CRRIACT
COCONUT OILQ9L0O73W7LIACT
AVOCADO OIL6VNO72PFC1IACT
HYDROGENATED AVOCADO OILJA69U4B4XIIACT
CARNAUBA WAXR12CBM0EIZIACT
SYNTHETIC BEESWAX08MNR5YE2RIACT
GRAPEFRUIT OILYR377U58W9IACT
EUCALYPTUS OIL2R04ONI662IACT
PEPPERMINT OILAV092KU4JHIACT
SPEARMINT OILC3M81465G5IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-01-14monthly-update2026-06-03 17:52:42

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icy Hot Pro Pain Massaging BalmCAMPHOR AND MENTHOLChattem, Inc.09e2b0cb-5186-4f9c-b256-edaced4ca0142026-02-27WarningsExact identifier
ndc (package): 41167-0790-0
ndc (product): 41167-0790
ndc11 (package): 41167079000
spl id: ec4a6b9d-fcf6-45d6-ae11-6a625378bd18
spl set id: 09e2b0cb-5186-4f9c-b256-edaced4ca014

Reported adverse events (FAERS/openFDA)#

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