ICY HOT PAIN RELIEVING STICK- menthol and methyl salicylate stick ICY HOT PAIN RELIEVING BALM- menthol and methyl salicylate ointment ICY HOT PAIN RELIEVING CREAM- menthol and methyl salicylate cream

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

ICYHOT® PAIN RELIEVING STICK
Drug Facts

Active ingredient

Menthol 10%

Methyl salicylate 30%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

• arthritis
  
• simple backache
  
• muscle strains
  
• sprains
  
• bruises
  
• cramps

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:

• apply generously to affected area
  
• massage into painful area until thoroughly absorbed into skin
  
• repeat as necessary, but not more than 4 times daily

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:

• arthritis
  
• simple backache
  
• muscle strains
  
• sprains
  
• bruises
  
• cramps

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:

• apply generously to affected area
  
• massage into painful area until thoroughly absorbed into skin
  
• repeat as necessary, but not more than 4 times daily

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:

• arthritis
  
• simple backache
  
• muscle strains
  
• sprains
  
• bruises
  
• cramps

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:

• apply generously to affected area
  
• massage into painful area until thoroughly absorbed into skin
  
• repeat as necessary, but not more than 4 times daily

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 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

INGREDIENTS AND APPEARANCE

ICY HOT  PAIN RELIEVING STICK
menthol and methyl salicylate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0089
Route of Administration	TOPICAL

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) (SALICYLIC ACID - UNII:O414PZ4LPZ)	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; Type 0: Not a Combination Product	06/01/1991

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  PAIN RELIEVING BALM
menthol and methyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0087
Route of Administration	TOPICAL

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) (SALICYLIC ACID - UNII:O414PZ4LPZ)	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; Type 0: Not a Combination Product	06/01/1991

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  PAIN RELIEVING CREAM
menthol and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0088
Route of Administration	TOPICAL

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) (SALICYLIC ACID - UNII:O414PZ4LPZ)	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	06/01/1991
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 41167-0088-5	1 in 1 CARTON	06/01/1991
2		35.4 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 41167-0088-8	1 in 1 CARTON	06/01/1991
3		44 g in 1 TUBE; 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	06/01/1991

Labeler - Chattem, Inc. (003336013)