ICY HOT KIDS PAIN RELIEF- menthol patch 
Chattem, Inc.

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

ICY HOT KIDS PAIN RELIEF PATCH

Drug Facts

Active ingredient

Purpose

Menthol 5%......................................................................................................................................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

PRODUCT SHOULD BE APPLIED UNDER ADULT SUPERVISION

Keep carton as it contains important information. 

PRINCIPAL DISPLAY PANEL

ICY HOT

KIDS

PAIN RELIEF PATCH

CONTAINS 5 PATCHES

PRINCIPAL DISPLAY PANEL
ICY HOT 
KIDS 
PAIN RELIEF PATCH
CONTAINS 5 PATCHES

ICY HOT KIDS PAIN RELIEF 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0099
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
NONOXYNOL-30 (UNII: JJX07DG188)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
METHYL ACRYLATE (UNII: WC487PR91H)  
ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
ACRYLIC ACID (UNII: J94PBK7X8S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0099-05 in 1 CARTON; Type 0: Not a Combination Product01/15/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/15/2023
Labeler - Chattem, Inc. (003336013)

Revised: 1/2023
Document Id: b5a33aca-e882-48d8-b7aa-416cc984c6c5
Set id: e78853de-d681-4d4c-8cde-0868739a4017
Version: 2
Effective Time: 20230123
 
Chattem, Inc.