Your browser does not support JavaScript! ICY HOT ADVANCED RELIEF (MENTHOL TOPICAL ANALGESIC) PATCH [CHATTEM, INC.]
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ICY HOT ADVANCED RELIEF (menthol topical analgesic) patch
[Chattem, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 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 in 1 CARTON
14 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
Document Id: ad7b463f-93d8-41b6-b251-a9d322a45f67
Set id: 1a100d2a-b0b1-47a2-a1df-5cc394a38b84
Version: 1
Effective Time: 20121109
 
Chattem, Inc.

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