Icy Hot Advanced Relief Cream

Manufacturer
Chattem, Inc.
Effective date
2024-03-01
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:57:50

Label at a glance#

ProductIcy Hot Advanced Relief
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
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:       ■ apply a thin layer to affected area not more than 3 to 4 times daily       ■ massage until thoroughly absorbed into skin       ■ 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

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

Camphor 11%

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 of 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

      ■ 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, steareth-21, stearic acid, triethanolamine, water 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ICY HOT®
ADVANCED
PAIN RELIEF
CREAM
NET WT 2 OZ (56 g) 

ICY HOT® ADVANCED PAIN RELIEF CREAM NET WT 2 OZ (56 g)ICY HOT® ADVANCED PAIN RELIEF CREAM NET WT 2 OZ (56 g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1373219camphor 11 % / menthol 16 % Topical CreamPSN7
1373219camphor 110 MG/ML / menthol 160 MG/ML Topical CreamSCD7
1373219camphor 11 % / menthol 16 % Topical CreamSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0801-0Icy Hot Advanced Relief56 g in 1 TUBECREAM567
41167-0801-0Icy Hot Advanced Relief1 in 1 CARTONCREAM17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0801ICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]7Current NDC, Legacy NDC, 2 package rows20250327_9979ff36-415b-44e4-bb10-6bf682cd00f9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0801-0GM - Gram41167-0801ca1740e5-75cd-4658-9c80-3e1767b9507f12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET1
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET1
MENTHOLACTIVE MOIETYL7T10EIP3A1
4-TERT-BUTYLCYCLOHEXANOLINACTIVE INGREDIENTK0H1405S9C1
ALLANTOININACTIVE INGREDIENT344S277G0Z1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5CO1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02B1
DIISOPROPYL ADIPATEINACTIVE INGREDIENTP7E6YFV72X1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7I1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PEG-150 STEARATEINACTIVE INGREDIENT7BSG7DF10Q1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZG1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85T1
SOY STEROLINACTIVE INGREDIENTPL360EPO9J1
STEARETH-21INACTIVE INGREDIENT53J3F32P581
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-080141167-0801-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / TOPICAL20 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
2 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BCREAM / TOPICAL1290 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BCREAM / TOPICAL1290 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIISOPROPYL ADIPATEDIISOPROPYL ADIPATEP7E6YFV72XCREAM / TOPICAL170 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARETH-21STEARETH-2153J3F32P58CREAM / TOPICAL3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARETH-21STEARETH-2153J3F32P58CREAM / TOPICAL3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIISOPROPYL ADIPATEDIISOPROPYL ADIPATEP7E6YFV72XCREAM / TOPICAL170 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / TOPICAL20 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 Advanced ReliefCAMPHOR AND MENTHOLChattem, Inc.9979ff36-415b-44e4-bb10-6bf682cd00f92024-03-01WarningsExact identifier
ndc (package): 41167-0801-0
ndc (product): 41167-0801
ndc11 (package): 41167080100
spl id: 990c7f7a-f472-4b03-8b80-db04a6056da4
spl set id: 9979ff36-415b-44e4-bb10-6bf682cd00f9

Reported adverse events (FAERS/openFDA)#

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