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Icy Hot by Chattem, Inc.

Dosage form: patch
Ingredients: MENTHOL 336mg
Labeler: Chattem, Inc.
NDC Code: 41167-0830

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 Medicated Sleeve

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

ICY HOT 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0830
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL336 mg
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
DIETHYLENE GLYCOL MONOETHYL ETHER 
DIISOPROPYL ADIPATE 
EDETATE DISODIUM 
GLYCERIN 
GLYCERYL DILAURATE 
GLYCERYL MONOSTEARATE 
MENTHYL LACTATE, (-)- 
METHYLPARABEN 
PEG-150 STEARATE 
PHENOXYETHANOL 
POLYSORBATE 80 
SOY STEROL 
WATER 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:41167-0830-03 POUCH (3 POUCH) in 1 CARTON
11 PATCH (1 PATCH) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34802/01/2004
ICY HOT 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0844
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL336 mg
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
CITRIC ACID MONOHYDRATE 
DIISOPROPYL ADIPATE 
EDETATE DISODIUM 
DIETHYLENE GLYCOL MONOETHYL ETHER 
GLYCERIN 
GLYCERYL DILAURATE 
GLYCERYL MONOSTEARATE 
MENTHYL LACTATE, (-)- 
METHYLPARABEN 
PEG-150 STEARATE 
PHENOXYETHANOL 
POLYSORBATE 80 
WATER 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:41167-0844-13 POUCH (3 POUCH) in 1 CARTON
11 PATCH (1 PATCH) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34802/01/2004
Labeler - Chattem, Inc. (003336013)

Revised: 02/2012
 
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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