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Icy Hot Kids Pain Relief

ICY Hot Kids Pain Relief - Patch

Approved
Approval ID

e78853de-d681-4d4c-8cde-0868739a4017

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 11, 2025

Manufacturers
FDA

Chattem, Inc.

DUNS: 003336013

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Menthol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code41167-0099
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Menthol
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 11, 2025
FDA Product Classification

INGREDIENTS (17)

MENTHOLActive
Quantity: 5 g in 1 1
Code: L7T10EIP3A
Classification: ACTIB
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
NONOXYNOL-30Inactive
Code: JJX07DG188
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SORBITAN SESQUIOLEATEInactive
Code: 0W8RRI5W5A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYL ACRYLATEInactive
Code: WC487PR91H
Classification: IACT
ETHYLHEXYL ACETATEInactive
Code: 2C7K8OA8SB
Classification: IACT
POLYACRYLIC ACID (250000 MW)Inactive
Code: 9G2MAD7J6W
Classification: IACT
SODIUM POLYACRYLATE (2500000 MW)Inactive
Code: 05I15JNI2J
Classification: IACT
ACRYLIC ACIDInactive
Code: J94PBK7X8S
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/11/2025

PRINCIPAL DISPLAY PANEL

ICY HOT
KIDS
PAIN RELIEF PATCH
CONTAINS 5 PATCHES

ICY HOT  KIDS  PAIN RELIEF PATCH  CONTAINS 5 PATCHES

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/11/2025

Uses

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/11/2025

Directions

■ children 5 years of age and older:

■ patch may be cut into smaller sizes with scissors prior to removal of the backing

■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle

■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area

■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to

affected area

■ apply to affected area not more than 3 to 4 times daily

■ wash hands after applying or removing patch. Throw away the patch by folding sticky ends together.

■ children under 5 years of age:****ask a doctor

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/11/2025

Inactive ingredients****

aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/11/2025

ICY HOTKIDS PATCH

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/11/2025

Active ingredient

Menthol 5%.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/11/2025

Purpose

Topical analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 8/11/2025

Warnings

For external use only

Do not use

■ on wounds or on irritated or damaged skin

■ with a heating pad

When using this product

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

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

■ your child experiences severe burning pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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Icy Hot Kids Pain Relief - FDA Drug Approval Details