ICY HOT MEDICATED, BACK- 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® Medicated Back Patch

Active ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

▪: arthritis
▪: simple backache
▪: bursitis
▪: tendonitis
▪: muscle strains
▪: sprains
▪: bruises
▪: cramps

Warnings

For external use only

When using this product

▪: use only as directed. Read and follow all directions and warnings on this label.
▪: avoid contact with eyes and mucous membranes
▪: rare cases of serious burns have been reported with products of this type
▪: do not apply to wounds or damaged, broken or irritated skin
▪: do not bandage tightly or apply local heat (such as heating pads) to the area of use
▪: a transient burning sensation may occur upon application but generally disappears in several days

Stop use and ask a doctor if

▪: condition worsens
▪: redness is present
▪: irritation develops
▪: symptoms persist for more than 7 days or clear up and occur again within a few days
▪: you experience signs of skin injury, such as 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

adults and children over 12 years:

▪: 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
▪: wear one Icy Hot patch for up to 8 hours
▪: repeat as necessary, but no more than 3 times daily

children 12 years or younger: 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 - Back & Large Areas

MENTHOL 5%

ICY HOT®
ORIGINAL
Pain Relief Patch

LARGE
PATCH

FEEL IT WORKING
INSTANTLY

➢: Powerful Targeted Relief
➢: Icy to Dull, Hot to Relax
➢: Comfortable Fabric
➢: Stays in Place

Wear For Up To 8 Hours

Contains 6 Patches in 1 Resealable Pouch
3-15/16” x 7-13/16” (10 cm x 20 cm) each

Pouch Label - Back and Large Areas

ICY HOT MEDICATED, BACK
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62168-0856
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	428.5 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62168-0856-1	80 in 1 CARTON	03/31/2021
1		6 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/31/2021

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

Revised: 2/2023

Document Id: 64ae4759-f450-4f5c-895b-078ab33802aa

Set id: 64ae4759-f450-4f5c-895b-078ab33802aa

Version: 1

Effective Time: 20230209

Lead Chemical Co., Ltd.