Icy Hot by Chattem, Inc. ICY HOT- 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

Drug Facts
Icy Hot Medicated Sleeve - Small

Active ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

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

Warnings

For external use only

When using this product

• use only as directed
  
• do not bandage tightly over sleeve or use with a heating pad
  
• avoid contact with eyes and mucous membranes
  
• do not apply to wounds or damaged, broken or irritated skin

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 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:

• remove plastic insert and discard
  
• pull ICY HOT® SLEEVE onto ankle, elbow or wrist – note: medicine is away from skin
  
• carefully pull ICY HOT® SLEEVE over itself, medicine will then be touching the skin
  note: the drawing (above) should help you understand how to do this
  
• apply one ICY HOT® SLEEVE to affected area
  
• repeat as necessary, but no more than 3 times daily
  
• sleeve should feel snug but not tight

children 12 years or younger: ask a doctor

Inactive ingredients

cetyl alcohol, diethylene glycol monoethyl ether, diisopropyl adipate, disodium EDTA, glycerin, glyceryl dilaurate, glyceryl stearate, menthyl lactate, methylparaben, PEG-150 stearate, phenoxyethanol, polysorbate 80, soya sterol, water, xanthan gum (may contain citric acid) (245-39)

Drug Facts
Icy Hot Medicated Sleeve - Large

Active ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

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

Warnings

For external use only

When using this product

• use only as directed
  
• do not bandage tightly over sleeve or use with a heating pad
  
• avoid contact with eyes and mucous membranes
  
• do not apply to wounds or damaged, broken or irritated skin

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 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:

• remove plastic insert and discard
  
• pull ICY HOT® SLEEVE onto ankle, elbow or knee – note: medicine is away from skin
  
• carefully pull ICY HOT® SLEEVE over itself, medicine will then be touching the skin
  note: the drawing (above) should help you understand how to do this
  
• apply one ICY HOT® SLEEVE to affected area
  
• repeat as necessary, but no more than 3 to 4 times daily
  
• sleeve should feel snug but not tight

children 12 years or younger: ask a doctor

Inactive ingredients

cetyl alcohol, citric acid, diisopropyl adipate, disodium EDTA, ethoxydiglycol, glycerin, glyceryl dilaurate, glyceryl stearate, glycine soja sterols, menthyl lactate, methylparaben, PEG-150 stearate, phenoxyethanol, polysorbate 80, water, xanthan gum (283-110)

PRINCIPAL DISPLAY PANEL

ICY HOT® MEDICATED SLEEVE
Menthol 16%
SMALL
Ankles, Elbows and Wrists
Contains 3 Individually Wrapped Sleeves
Expands to fit 5” to 12” in circumference

PRINCIPAL DISPLAY PANEL

ICY HOT® MEDICATED SLEEVE
Menthol 16%
LARGE
Ankles, Elbows and Knees
Contains 3 Individually Wrapped Sleeves
Expands to fit 8” to 24” in circumference

INGREDIENTS AND APPEARANCE

ICY HOT 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0830
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	336 mg

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-150 STEARATE (UNII: 7BSG7DF10Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SOY STEROL (UNII: PL360EPO9J)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0830-0	3 in 1 CARTON	02/01/2004	03/25/2015
1		1 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	02/01/2004	03/25/2015

ICY HOT 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0844
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	336 mg

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-150 STEARATE (UNII: 7BSG7DF10Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0844-1	3 in 1 CARTON	02/01/2004
1		1 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	02/01/2004

Labeler - Chattem, Inc. (003336013)