Icy Hot Cream

Manufacturer
Chattem, Inc.
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:56:39

Label at a glance#

ProductIcy Hot with Lidocaine Pain Relieving
Active ingredientLIDOCAINE, MENTHOL
Label structure10 sections

Dosage and administration

■ adults and children 12 years of age and older:       ■ apply a thin layer to affected area every 6 to 8 hours, 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

ICY HOT®  with LIDOCAINE

PAIN RELIEVING CREAM

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Purposes

OTC - PURPOSE SECTION

Topical anesthetic

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 1 %

Purposes

OTC - PURPOSE SECTION

Topical analgesic

Use

INDICATIONS & USAGE SECTION

for the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

■ in large quantities

■ 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 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

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 and pets.

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 every 6 to 8 hours, 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

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (15%), aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, methylparaben, polysorbate 60, steareth-21, water

Keep Carton As It Contains Important Information

Close cap tightly between uses.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ICY HOT
MAX
LIDOCAINE
PAIN RELIEF CREAM
Net Wt 2.7 OZ (76.5 g)

PRINCIPAL DISPLAY PANEL ICY HOT MAX LIDOCAINE PAIN RELIEF CREAM Net Wt 2.7 OZ (76.5 g)PRINCIPAL DISPLAY PANEL ICY HOT MAX LIDOCAINE PAIN RELIEF CREAM Net Wt 2.7 OZ (76.5 g)

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-1710-0Icy Hot with LidocainePain Relieving76.5 g in 1 TUBECREAM76.56
41167-1710-0Icy Hot with LidocainePain Relieving1 in 1 CARTONCREAM16
41167-1710-2Icy Hot with LidocainePain Relieving1 in 1 CARTONCREAM16
41167-1710-2Icy Hot with LidocainePain Relieving49.6 g in 1 TUBECREAM49.66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-1710ICY HOT WITH LIDOCAINE PAIN RELIEVING (LIDOCAINE HCL AND MENTHOL) CREAM [CHATTEM, INC.]6Current NDC, Legacy NDC, 4 package rows20250306_75b28b06-77ea-4fea-b516-2e8a0dac7037.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-1710-2GM - Gram41167-1710897a2580-0893-46a6-989d-8929ad3476ee12022-06-06

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-171041167-1710-2, 41167-1710-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML

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 with Lidocaine Pain RelievingLIDOCAINE HCL AND MENTHOLChattem, Inc.75b28b06-77ea-4fea-b516-2e8a0dac70372025-01-01WarningsExact identifier
ndc (package): 41167-1710-0
ndc (package): 41167-1710-2
ndc (product): 41167-1710
ndc11 (package): 41167171000
ndc11 (package): 41167171002
spl id: 8039f76a-9f40-4e6c-9228-9d9e73013101
spl set id: 75b28b06-77ea-4fea-b516-2e8a0dac7037

Reported adverse events (FAERS/openFDA)#

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