ICY HOT PRO DRY- camphor, menthol spray

Icy Hot Pro Dry by

Drug Labeling and Warnings

Icy Hot Pro Dry 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 DRY SPRAY 

Drug Facts

Active ingredients

Purpose

Camphor 11%, Menthol 16%.............................................................................................................Topical analgesic

Use

temporarily relieves minor aches and pains of muscles and joints associated with:

■ arthritis     ■ simple backache     ■ strains  ■ sprains     ■ bruises                                

Warnings

For external use only

Extremely flammable: keep away from fire, sparks, and heated surfaces. Contents under pressure, do not puncture or incinerate container. Exposure to temperatures above 120°F may cause bursting.

Do not use

■ on wounds or on irritated or damaged skin

■ with a heating pad

When using this product

■ use only as directed. Intentional misuse by deliberately concentrating or inhaling the contents can be harmful or fatal.

■ do not bandage tightly

■ avoid contact with eyes and mucous membranes. Do not spray in face or mouth.

■ do not expose the area to local heat or 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:
  ▪ spray the affected area not more than 3 to 4 times daily
  ▪ product will dry quickly on its own, and does not need to be rubbed in
  ▪ wash hands thoroughly with soap and water after each use
  
• children under 12 years of age: ask a doctor

Inactive ingredients:

alcohol denat., glycerin, isobutane, propylene glycol, water

                                                                              357-097

PRINCIPAL DISPLAY PANEL

ICY HOT
PRO
Pain Relief

DRY SPRAY
NET WT 4 oz (113g)

INGREDIENTS AND APPEARANCE

ICY HOT PRO DRY 
camphor, menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	11 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
ISOBUTANE (UNII: BXR49TP611)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0080-4	118 mL in 1 CAN; Type 0: Not a Combination Product	02/21/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/21/2022

Labeler - Chattem, Inc. (003336013)