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 Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0089
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 30 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
CERESIN (UNII: Q1LS2UJO3A)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41167-0089-8 49 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 06/01/1991
ICY HOT 
menthol and methyl salicylate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0087
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 7.6 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 29 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41167-0087-9 99 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 06/01/1991
ICY HOT 
menthol and methyl salicylate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0088
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 30 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
CETYL ESTERS WAX (UNII: D072FFP9GU)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41167-0088-1 1 in 1 CARTON
1 85 g in 1 TUBE
2 NDC:41167-0088-5 1 in 1 CARTON
2 35 g in 1 TUBE
3 NDC:41167-0088-8 1 in 1 CARTON
3 44 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 06/01/1991
Labeler - Chattem, Inc. (003336013)
Establishment
Name Address ID/FEI Business Operations
Chattem Plant 1 003336013 MANUFACTURE
Establishment
Name Address ID/FEI Business Operations
Chattem Plant 2 830410721 MANUFACTURE

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