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Icy Hot Advanced Relief by Chattem, Inc.

Dosage form: patch
Ingredients: MENTHOL 210mg
Labeler: Chattem, Inc.
NDC Code: 41167-0805

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.

Icy Hot Advanced Relief

Active Ingredient

Menthol 7.5%

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 use at the same time as other topical analgesics

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

If pregnant of 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:

  • gently fold the path in half to remove center section of film backing. Apply the exposed adhesive portion to the site of pain.
  • remove remaining film backing from both sides and finish applying to skin
  • use 1 patch for up to 12 hours, once a day

Children 12 years and younger: ask a doctor

Inactive ingredients

glyceryl hydrogenated rosinate, hydrated silica, mineral oil, PEG-400, polyisobutene, styrne/isoprene copolymer

Principal Display Panel

ICY HOT®
ADVANCED RELIEF
PAIN RELIEF PATCH
ADVANCED RELIEF at the POINT of PAIN
50% MORE MEDICINE
LONG LASTING RELIEF
FLEXIBLE, NO MESS FABRIC
Easy to Apply and Remove
Contains 4 Patches in 1 Resalable Pouch
3 15/16” x 5 ½” (10 cm x 14 cm) each

ICY HOT ADVANCED RELIEF 
menthol topical analgesic patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0805
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL210 mg
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA 
MINERAL OIL 
POLYETHYLENE GLYCOL 400 
POLYISOBUTYLENE (1000 MW) 
Packaging
#Item CodePackage Description
1NDC:41167-0805-01 POUCH (1 POUCH) in 1 CARTON
14 PATCH (4 PATCH) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34812/01/2012
Labeler - Chattem, Inc. (003336013)

Revised: 11/2012
 
Chattem, Inc.

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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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