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ICYHOT Medicated

Dosage form: spray
Ingredients: MENTHOL 160mg in 1mL
Labeler: Chattem, Inc.
NDC Code: 41167-0095

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ICYHOT Medicated Spray

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)

ICYHOT MEDICATED  
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0095
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL160 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:41167-0095-0118 mL in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34812/06/2012
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIOperations
Formulated Solutions, LLC143266687MANUFACTURE(41167-0095)

Revised: 12/2012
 
Chattem, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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