ICYHOT MEDICATED- menthol spray

ICYHOT Medicated by

Drug Labeling and Warnings

ICYHOT Medicated by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., Formulated Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ICYHOT Medicated Spray

Active Ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:  

• arthritis
  
• simple backache  
  
• muscle strains  
  
• sprains  
  
• bruises  
  
• cramps

Warnings

For external use only

When using this product

• use only as directed
  
• do not bandage tightly or use with a heating pad
  
• avoid contact with eyes and mucous membranes
  
• do not apply to wounds or damaged, broken or irritated skin
  
• do not spray onto face  
  
• avoid inhaling spray mist and fumes

Stop use and ask a doctor

• condition worsens
  
• redness is present  
  
• irritation develops
  
• symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable

• do not use near heat or flame or while smoking
  
• avoid long term storage above 104ºF (40ºC)
  
• do not puncture or incinerate. Contents under pressure.
  
• do not store at temperatures above 120ºF (49ºC)

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:

• spray affected area with desired amount of product
  
• product will dry quickly on its own, and does not need to be rubbed in
  
• repeat as necessary, but no more than 3-4 times daily

children 12 years or younger: ask a doctor

Inactive Ingredients

glycerin, propylene glycol, SD alcohol 40-2 (55%), water (283-016)

Dist. by Chattem, Inc., P.O. Box 2219

Chattanooga, TN 37409-0219

USA ©2010 www.icyhot.com

ICYHOT Medicated Spray 118ml

ICY HOT®  

MEDICATED

SPRAY

Menthol 16%

FAST, LONG LASTING RELIEF

• No-Mess Continuous Spray
  
• Works at Any Angle
  
• Dries Quickly

MAXIMUM STRENGTH

PAIN RELIEF SPRAY

4 FL OZ (118 ML)

INGREDIENTS AND APPEARANCE

ICYHOT MEDICATED  
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0095
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	160 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0095-0	118 mL in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	12/06/2012

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Formulated Solutions, LLC		143266687	MANUFACTURE(41167-0095)