ICY HOT KIDS PAIN RELIEF- menthol patch

Icy Hot by

Drug Labeling and Warnings

Icy Hot by is a Otc medication manufactured, distributed, or labeled by Lead Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Label

INGREDIENTS AND APPEARANCE

ICY HOT  KIDS PAIN RELIEF
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62168-0228
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	205.5 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62168-0228-1	270 in 1 CARTON	01/31/2023	03/31/2026
1		5 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/31/2023	03/31/2026

Labeler - Lead Chemical Co., Ltd. (693727091)