ICY HOT PRO PAIN- camphor and menthol patch

Icy Hot Pro Pain by

Drug Labeling and Warnings

Icy Hot Pro Pain by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ICY HOT PRO PAIN PATCH

Drug Facts

Active ingredients 

Camphor 3%

Menthol 5%

Purpose

Topical analgesic

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

Keep carton as it contains important information.

Principal Display Panel

ICY HOT PRO
PAIN RELIEF PATCH
EXTRA STRENGTH WITH 2 PAIN RELIEVERS
MENTHOL 5%
CAMPHOR 3%
CONTAINS 5 PATCHES IN 1 RESEALABLE POUCH

INGREDIENTS AND APPEARANCE

ICY HOT PRO PAIN 
camphor and menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0074
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 (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	300 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL ACRYLATE (UNII: WC487PR91H)
ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB)
NONOXYNOL-30 (UNII: JJX07DG188)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
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: 41167-0074-0	5 in 1 CARTON; Type 0: Not a Combination Product	01/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/15/2023

Labeler - Chattem, Inc. (003336013)