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Icy Hot Medicated Roll Medium by Chattem, Inc.

Dosage form: patch
Ingredients: MENTHOL 787.5mg
Labeler: Chattem, Inc.
NDC Code: 41167-0850

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 - Roll

Icy Hot® - Medicated Roll Medium

Wrist, Ankle, Shoulder

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
  • do not overwrap or wrap strips over themselves
  • do not wrap around neck
  • do not apply over large areas of the body or apply in strips longer than 6 inches
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin, 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.
  • tear or cut roll to desired size
  • carefully remove backing from one end of strip and place on affected area
  • remove remaining backing and press into place
  • wear one Icy Hot Medicated Roll up to 8 hours
  • repeat as necessary, but no more than 3 to 4 times daily

children 12 years or younger: ask a doctor

Inactive Ingredients

caprylic/capric triglyceride, 2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)

phenol, mineral oil, petroleum resins, polyisobutene, polyisoprene, styrene/isoprene copolymer, terpene polymer (245-286)

Keep carton as it contains important information for usage of this product.

Distributed by Chattem, Inc.

P.O. Box 2219

Chattanooga, TN 37409-0219 USA

©2009 www.icyhot.com

Chattem ®

ROLL MADE IN JAPAN             Recyclable Carton       0044605-04

Icy Hot® - Medicated Roll Large

Knee, Shoulder, Back

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
  • do not overwrap or wrap strips over themselves
  • do not wrap around neck
  • do not apply over large areas of the body or apply in strips longer than 6 inches
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin, 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.
  • tear or cut roll to desired size
  • carefully remove backing from one end of strip and place on affected area
  • remove remaining backing and press into place
  • wear one Icy Hot Medicated Roll up to 8 hours
  • repeat as necessary, but no more than 3 to 4 times daily

children 12 years or younger: ask a doctor

Inactive Ingredients

caprylic/capric triglyceride, 2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)

phenol, mineral oil, petroleum resins, polyisobutene, polyisoprene, styrene/isoprene copolymer, terpene polymer (245-286)

Keep carton as it contains important information for usage of this product.

Distributed by Chattem, Inc.

P.O. Box 2219

Chattanooga, TN 37409-0219 USA 

©2009 www.icyhot.com  

Chattem ®

ROLL MADE IN JAPAN             Recyclable Carton       0044614-04

Principal Display Panel

ICY HOT®  

MEDICATED

ROLL

Menthol 7.5%

CUSTOMIZED

PAIN RELIEF

  • Tear or Cut for a Custom Fit
  • Lasts up to 8 Hours
  • Comfortable, Flexible, Stays in Place

EXTRA STRENGTH

MEDIUM – 2”

Wrist, Ankle, Shoulder

1 Roll in Resealable Pouch

2 x 60 (5 cm x 150 cm)

Pain Relieving Ointment

on a Breathable, Flexible Fabric

Principal Display Panel

ICY HOT®  

MEDICATED

ROLL

Menthol 7.5%

CUSTOMIZED

PAIN RELIEF

  • Tear or Cut for a Custom Fit
  • Lasts up to 8 Hours
  • Comfortable, Flexible, Stays in Place

EXTRA STRENGTH

LARGE – 3”

Knee, Shoulder, Back

1 Roll in Resealable Pouch

3 x 43 (7.5 cm x 110 cm)

Pain Relieving Ointment

on a Breathable, Flexible Fabric

ICY HOT MEDICATED ROLL MEDIUM 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0850
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL787.5 mg
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES 
PHENOL, 4-((4,6-BIS(OCTYLTHIO)-1,3,5-TRIAZIN-2-YL)AMINO)-2,6-BIS(1,1-DIMETHYLETHYL)- 
MINERAL OIL 
Packaging
#Item CodePackage Description
1NDC:41167-0850-11 POUCH (1 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 FINALpart34804/01/2009
ICY HOT MEDICATED ROLL LARGE 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0851
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL866.25 mg
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES 
PHENOL, 4-((4,6-BIS(OCTYLTHIO)-1,3,5-TRIAZIN-2-YL)AMINO)-2,6-BIS(1,1-DIMETHYLETHYL)- 
MINERAL OIL 
Packaging
#Item CodePackage Description
1NDC:41167-0851-71 POUCH (1 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 FINALpart34804/01/2009
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIOperations
Nichiban Company Limited.693727091ANALYSIS, MANUFACTURE

Revised: 12/2009
 
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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