ICY HOT MEDICATED MICRO- menthol patch

Icy Hot by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Icy Hot® - Medicated MICRO Patch

Back, Shoulder, Elbow, Neck, Knee & Small Areas

Active ingredient

Menthol 7.5%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

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

Warnings

For external use only

When using this product

• use only as directed. Read and follow all directions and warnings on this carton.
  
• rare cases of serious burns have been reported with products of this type
  
• do not bandage tightly or apply local heat (such as heating pads) to the area of use
  
• avoid contact with eyes and mucous membranes
  
• do not apply to wounds or damaged skin, broken or irritated skin 
  
• do not use at the same time as other topical analgesics
  
• do not use more than 4 patches at a time

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
  
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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:

• gently fold patch in half and remove one side of backing. Apply exposed adhesive to the site of pain.
  
• remove remaining film from the other side and finish applying to skin.
  
• use on affected areas for up to 12 hours

children 12 years or younger: ask a doctor

Inactive ingredients

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

Principal Display Panel

NEW! 24 Patches for Targeted Relief
ICY HOT®  
MEDICATED
MICRO PATCH
Menthol 7.5%
ULTRA STRENGTH
Back, Shoulder, Elbow,
Neck, Knee & Small Areas
24 Patches in 1 Resealable Pouch
2.56” x 1.65” (6.5 cm x 4.2 cm) each
Pain Relieving Ointment on
Breathable, Flexible Fabric

INGREDIENTS AND APPEARANCE

ICY HOT  MEDICATED MICRO
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0827
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50.25 mg

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0827-0	1 in 1 CARTON	01/02/2015
1		24 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	01/02/2015

Labeler - Chattem, Inc. (003336013)