ICY HOT PRO PAIN RELIEF- camphor, 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 ingredients

Camphor 3%
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
• ▪ you experience 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

adults and children 12 years of age and older:

• ▪ 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 12 years of age: ask a doctor

Inactive ingredients

aluminum hydroxide, cellulose gum, disodium EDTA, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, talc, tartaric acid, titanium dioxide, water

Principal Display Panel – Pouch Label

ICY HOT®

PRO
PAIN RELIEF
PATCH
WEAR FOR UP
TO 8 HOUR
EXTRA STRENGTH WITH 2 PAIN RELIEVERS

MENTHOL 5%
CAMPHOR 3%
Contains 5 Patches in 1 Resealable Pouch
3-15/16" x 5-1/2" (10 cm x 14 cm) each


SANOFI CONSUMER HEALTH CARE
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  PRO PAIN RELIEF
camphor, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62168-0210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	180 mg
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	300 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-30 (UNII: JJX07DG188)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
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: 62168-0210-1	160 in 1 CARTON	01/31/2023
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

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