FDA.reportPublic FDA data

Arthritis Hot

Manufacturer
Chattem, Inc.
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:53:16

Label at a glance#

ProductArthritis Hot
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure15 sections

Indications and uses

temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Dosage and administration

adults and children over 12 years: ■ apply a thin layer to affected area ■ massage into painful area until thoroughly absorbed into skin ■ repeat as necessary, but no more than 3 to 4 times daily ■  IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER children 12 years or younger: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Methyl salicylate 15%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

WARNINGS SECTION

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

OTC - WHEN USING SECTION

■ use only as directed. Read and follow all directions and warnings on this label.

■ rare cases of serious burns have been reported with products of this type

■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

■ avoid contact with eyes and mucous membranes

■ do not apply to wounds or damaged, broken or irritated skin

■ 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care 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 over 12 years:

■ apply a thin layer to affected area

■ massage into painful area until thoroughly absorbed into skin

■ repeat as necessary, but no more than 3 to 4 times daily

■ IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 12 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, cetearyl alcohol, cetyl esters, diisapropyl adipate, oleth-3 phosphate, polysorbate 60, stearic acid, triethanolamine, water

Arthritis Hot Cream

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Methyl salicylate 15%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises

Warnings

WARNINGS SECTION

For external use only

Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

OTC - WHEN USING SECTION

 ■ use only as directed. Read and follow all directions and warnings on this label.

■ rare cases of serious burns have been reported with products of this type

■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

■ avoid contact with eyes and mucous membranes

■ do not apply to wounds or damaged, broken or irritated skin

■ 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

OTC - STOP USE SECTION

  • 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,

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 over 12 years:

■ apply a thin layer to affected area

■ massage into painful area until thoroughly absorbed into skin

■ repeat as necessary, but no more than 3 to 4 times daily

■ IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 12 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, cetearyl alcohol, cetyl esters, diisapropyl adipate, oleth-3 phosphate, polysorbate 60, stearic acid, triethanolamine, water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41167-0600-4
Arthritis Penetrating Pain Relief Cream
NET WT 3 OZ (85g)

PRINCIPAL DISPLAY PANEL NDC 41167-0600-4 Arthritis Penetrating Pain Relief Cream NET WT 3 OZ (85g)PRINCIPAL DISPLAY PANEL NDC 41167-0600-4 Arthritis Penetrating Pain Relief Cream NET WT 3 OZ (85g)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41167-0600-3
Arthritis Deep Penetrating Pain Relief Crème
NET WT 3 OZ (85g)

PRINCIPAL DISPLAY PANEL NDC 41167-0600-3 Arthritis Deep Penetrating Pain Relief Crème NET WT 3 OZ (85g)PRINCIPAL DISPLAY PANEL NDC 41167-0600-3 Arthritis Deep Penetrating Pain Relief Crème NET WT 3 OZ (85g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2105947Arthritis Hot Pain Relief 10 % / 15 % Topical CreamPSN6
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN6
2105947menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical Cream [Arthritis Hot Pain Relief]SBD6
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD6
2105947Arthritis Hot Pain Relief (menthol 10 % / methyl salicylate 15 % ) Topical CreamSY6
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY6
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0600-3Arthritis Hot1 in 1 CARTONCREAM16
41167-0600-3Arthritis Hot85 g in 1 TUBECREAM856
41167-0600-4Arthritis Hot85 g in 1 TUBECREAM856
41167-0600-4Arthritis Hot1 in 1 CARTONCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0600ARTHRITIS HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]6Current NDC, Legacy NDC, 4 package rows20250121_cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0600-3GM - Gram41167-06009aa64bf4-7746-4677-82e8-c4b7bb36e19712018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOL, UNSPECIFIED FORMACTIVE INGREDIENTL7T10EIP3A2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y2
MENTHOL, UNSPECIFIED FORMACTIVE MOIETYL7T10EIP3A2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ2
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GU2
DIISOPROPYL ADIPATEINACTIVE INGREDIENTP7E6YFV72X2
OLETH-3 PHOSPHATEINACTIVE INGREDIENT8Q0Z18J1VL2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-060041167-0600-3, 41167-0600-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
CETYL ESTERS WAXD072FFP9GUIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
CETEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT

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 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DIISOPROPYL ADIPATEDIISOPROPYL ADIPATEP7E6YFV72XCREAM / TOPICAL170 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL ESTERS WAXCETYL ESTERS WAXD072FFP9GUCREAM / TOPICAL10.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL ESTERS WAXCETYL ESTERS WAXD072FFP9GUCREAM / TOPICAL10.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DIISOPROPYL ADIPATEDIISOPROPYL ADIPATEP7E6YFV72XCREAM / TOPICAL170 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DIISOPROPYL ADIPATEDIISOPROPYL ADIPATEP7E6YFV72XCREAM / TOPICAL170 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL ESTERS WAXCETYL ESTERS WAXD072FFP9GUCREAM / TOPICAL10.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
3 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
Arthritis HotMENTHOL AND METHYL SALICYLATEChattem, Inc.cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd2025-01-13WarningsExact identifier
ndc (package): 41167-0600-4
ndc (package): 41167-0600-3
ndc (product): 41167-0600
ndc11 (package): 41167060003
ndc11 (package): 41167060004
spl id: cdac5f97-06f4-409b-9233-94a45e308c88
spl set id: cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd

Reported adverse events (FAERS/openFDA)#

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