ICY HOT ADVANCED RELIEF- menthol topical analgesic patch

Icy Hot Advanced Relief by

Drug Labeling and Warnings

Icy Hot Advanced Relief by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 patch 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, styrene/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

INGREDIENTS AND APPEARANCE

ICY HOT ADVANCED RELIEF 
menthol topical analgesic patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0805
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	210 mg

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0805-0	1 in 1 CARTON	12/01/2012
1		4 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	12/01/2012

Labeler - Chattem, Inc. (003336013)