ICY HOT MEDICATED, BACK- 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 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 - Large Patch (6 Patch Pouch)

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

CHATTEM®
Dist. by Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2020     www.icyhot.com
Made in Japan

Pouch Label

INGREDIENTS AND APPEARANCE

ICY HOT  MEDICATED, BACK
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62168-0856
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	428.5 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62168-0856-1	80 in 1 CARTON	03/31/2021	02/28/2025
1		6 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)	03/31/2021	02/28/2025

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