ICY HOT- menthol and methyl salicylate stick 
ICY HOT- menthol and methyl salicylate ointment 
ICY HOT- menthol and methyl salicylate cream 
Chattem, Inc.

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.

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Icy Hot

ICYHOT® PAIN RELIEVING STICK
Drug Facts

Active ingredient

Menthol 10%

Methyl salicylate 30%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

Warnings

For external use only

SEE INSIDE LABEL FOR COMPLETE DRUG FACTS

Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or 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 care 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:

children 12 years or younger: ask a doctor

Inactive ingredients

ceresin, cyclomethicone, hydrogenated castor oil, microcrystalline wax, paraffin, PEG-150 distearate, propylene glycol, stearic acid, stearyl alcohol (245-111)





ICYHOT® PAIN RELIEVING BALM
Drug Facts

Active ingredient

Menthol 7.6%

Methyl salicylate 29%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

Warnings

For external use only

Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly or use with a heating pad
  • 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 care professional before use.

Keep out of reach of children.

If case of accidental ingestion, get medical help or contact a Poison Control Center right away.

continued on cap

Directions

adults and children over 12 years:

children 12 years or younger: ask a doctor

Inactive ingredients

paraffin, white petrolatum (245-109)




ICYHOT® PAIN RELIEVING CREAM
Drug Facts

Active ingredient

Menthol 10%

Methyl salicylate 30%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

Warnings

For external use only

Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

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

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

If case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

adults and children over 12 years:

children 12 years or younger: ask a doctor

Inactive ingredients

carbomer, cetyl esters, emulsifying wax, oleth-3 phosphate, stearic acid, triethanolamine, water (245-110)

Close cap tightly after use.





PRINCIPAL DISPLAY PANEL

ICYHOT® PAIN RELIEVING STICK
EXTRA STRENGTH
PAIN RELIEVING STICK

Net wt 1.75 oz (49 g)

PRINCIPAL DISPLAY PANEL
ICYHOT® PAIN RELIEVING STICK
EXTRA STRENGTH
Net wt 1.75 oz (49 g)

PRINCIPAL DISPLAY PANEL

ICYHOT® PAIN RELIEVING BALM
EXTRA STRENGTH

Net wt 3.5 oz (99.2 g)

PRINCIPAL DISPLAY PANEL
ICYHOT® PAIN RELIEVING BALM
EXTRA STRENGTH
Net wt 3.5 oz (99.2 g)

PRINCIPAL DISPLAY PANEL

ICYHOT® PAIN RELIEVING CREAM
Net wt
1.25 oz (35.4 g)
EXTRA STRENGTH

PRINCIPAL DISPLAY PANEL
ICYHOT® PAIN RELIEVING CREAM
Net wt 1.25 oz (35.4 g)
EXTRA STRENGTH

ICY HOT 
menthol and methyl salicylate stick
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41167-0089
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL10 g  in 100 g
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CERESIN 
CYCLOMETHICONE 
HYDROGENATED CASTOR OIL 
MICROCRYSTALLINE WAX 
PARAFFIN 
PEG-150 DISTEARATE 
PROPYLENE GLYCOL 
STEARIC ACID 
STEARYL ALCOHOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0089-849 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34806/01/1991
ICY HOT 
menthol and methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41167-0087
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL7.6 g  in 100 g
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE29 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PARAFFIN 
PETROLATUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0087-999 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34806/01/1991
ICY HOT 
menthol and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41167-0088
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL10 g  in 100 g
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ESTERS WAX 
OLETH-3 PHOSPHATE 
STEARIC ACID 
WATER 
TROLAMINE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0088-11 in 1 CARTON
185 g in 1 TUBE
2NDC:41167-0088-51 in 1 CARTON
235 g in 1 TUBE
3NDC:41167-0088-81 in 1 CARTON
344 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34806/01/1991
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIBusiness Operations
Chattem Plant 1003336013MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Chattem Plant 2830410721MANUFACTURE

Revised: 4/2011
Document Id: bb41ab75-a2c0-4a26-a056-4de05e67e45c
Set id: 40c8c02f-fa5f-4e80-81a0-48271fa6f94b
Version: 3
Effective Time: 20110422
 
Chattem, Inc.