Icy Hot Kids Pain Relief Roll-On

Manufacturer
Chattem, Inc.
Effective date
2023-10-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:57:42

Label at a glance#

ProductIcy Hot Kids Pain Relief Roll-On
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

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

Dosage and administration

■ children 2 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 2 years of age: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Icy Hot Kids Pain Relief Roll-On

Drug Facts

Purpose

OTC - PURPOSE SECTION

Menthol 4%.........................................................................................................................Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

■ sprains ■ bruises ■ simple backache    

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 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.

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

■ children 2 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 2 years of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

allantoin, aloe barbadensis leaf juice, carbomer, citric acid, diisopropyl adipate, ethylhexylglycerin, glycerin, hydroxyacetophenone, potassium hydroxide, steareth-2, steareth-21, water

PRODUCT SHOULD BE APPLIED UNDER ADULT SUPERVISION. Close cap tightly after use.

Keep carton as it contains important information.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Icy Hot
Kids Pain Relief
Roll-On
1.5 FL OZ (44.3 mL) ROLL-ON

PRINCIPAL DISPLAY PANEL Icy Hot Kids Pain Relief Roll-On 1.5 FL OZ (44.3 mL) ROLL-ONPRINCIPAL DISPLAY PANEL Icy Hot Kids Pain Relief Roll-On 1.5 FL OZ (44.3 mL) ROLL-ON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283438menthol 4 % Topical SolutionPSN2
283438menthol 40 MG/ML Topical SolutionSCD2
283438menthol 4 % Topical SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0799-0Icy Hot Kids Pain Relief Roll-On1 in 1 CARTONLIQUID12
41167-0799-0Icy Hot Kids Pain Relief Roll-On44.3 mL in 1 BOTTLELIQUID44.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0799ICY HOT KIDS PAIN RELIEF ROLL-ON (MENTHOL) LIQUID [CHATTEM, INC.]22 package rows20231026_5466e3ce-e591-40e9-a83f-40ac626418d2.zip

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
41167-079941167-0799-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
63681345-a143-4ef9-8dab-c940a91cebf75466e3ce-e591-40e9-a83f-40ac626418d22023-10-25WarningsExact identifier
spl id: 63681345-a143-4ef9-8dab-c940a91cebf7
spl set id: 5466e3ce-e591-40e9-a83f-40ac626418d2

Reported adverse events (FAERS/openFDA)#

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