FDA.reportPublic FDA data

Icy Hot Performance Cream

Manufacturer
Chattem, Inc.
Effective date
2026-07-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-18 02:03:13

Label at a glance#

ProductIcy Hot Performance Cream Pain Relief
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure7 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: apply a thin layer to affected area not more than 3 to 4 times daily massage until thoroughly absorbed into skin if product unintentionally gets on hands, wash hands thoroughly with soap and water after each use children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Icy Hot Performance Pain Relief Cream

Drug Facts

Purpose

OTC - PURPOSE SECTION

Camphor 11% ……………………………………………………………………………………Topical analgesic

Menthol 16% ………………..……………………………………………………………………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

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:
    • apply a thin layer to affected area not more than 3 to 4 times daily
    • massage until thoroughly absorbed into skin
    • if product unintentionally gets on hands, wash hands thoroughly with soap and water after each use

  • children under 12 years of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

4-t-butylcyclohexanol, acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., allantoin, aloe barbadensis leaf juice, cetyl alcohol, citrus paradisi (grapefruit) peel oil, farnesol, fragrance, glyceryl stearate, mentha piperita (peppermint) oil, mentha viridis (spearmint) leaf oil, pentylene glycol, propanediol, potassium hydroxide, steareth-21, stearic acid, water

     

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ICY HOT
PERFORMANCE
CREAM
PAIN RELIEF

PRINCIPAL DISPLAY PANEL ICY HOT PERFORMANCE CREAM PAIN RELIEFPRINCIPAL DISPLAY PANEL ICY HOT PERFORMANCE CREAM PAIN RELIEF      

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-080341167-0803-2, 41167-0803-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
4-T-BUTYLCYCLOHEXANOLK0H1405S9CIACT
ALCOHOL3K9958V90MIACT
ALLANTOIN344S277G0ZIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
CETYL ALCOHOL936JST6JCNIACT
CITRUS PARADISI (GRAPEFRUIT) PEEL OILYR377U58W9IACT
FARNESOLEB41QIU6JLIACT
GLYCERYL STEARATE230OU9XXE4IACT
MENTHA PIPERITA (PEPPERMINT) OILAV092KU4JHIACT
MENTHA VIRIDIS (SPEARMINT) LEAF OILC3M81465G5IACT
PENTYLENE GLYCOL50C1307PZGIACT
PROPANEDIOL5965N8W85TIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
STEARETH-2153J3F32P58IACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-07-03weekly-update2026-07-17 21:43:45

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 Performance Cream Pain ReliefMENTHOL 16%, CAMPHOR 11%Chattem, Inc.73f7a113-ef11-4932-bf4d-4e62863f79412026-07-23WarningsExact identifier
ndc (package): 41167-0803-2
ndc (package): 41167-0803-0
ndc (product): 41167-0803
ndc11 (package): 41167080302
ndc11 (package): 41167080300
spl id: 994ed274-b6f6-420b-9d03-d22536a85405
spl set id: 73f7a113-ef11-4932-bf4d-4e62863f7941

Reported adverse events (FAERS/openFDA)#

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