ICY HOT KIDS PAIN RELIEF- menthol patch 
Lead Chemical Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ICY HOT® Kids Pain Relief Patch

Active ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

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

arthritis
simple backache
strains
sprains
bruises

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.

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 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

Principal Display Panel – Pouch Label

ICY HOT®
 
KIDS
PAIN RELIEF
PATCH
 
FAST ACTING
EASY TO APPLY AND REMOVE
WEAR UP TO 8 HOURS
WITH NATURALLY-SOURCED
MENTHOL 5%
 
DEVELOPED WITH PEDIATRICIANS
AGES 5+
 
CONTAINS 5 PATCHES IN ONE RESEALABLE POUCH
3-1/8" x 4-5/8" (8 cm x 12 cm) EACH
 
 
PRODUCT SHOULD BE APPLIED UNDER ADULT SUPERVISION

Dist. by Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2022     www.icyhot.com

image-01

Label

ICY HOT  KIDS PAIN RELIEF
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0228
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM205.5 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
NONOXYNOL-30 (UNII: JJX07DG188)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62168-0228-1270 in 1 CARTON01/31/2023
15 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/31/2023
Labeler - Lead Chemical Co., Ltd. (693727091)

Revised: 9/2022
 
Lead Chemical Co., Ltd.