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 A-S Medication Solutions. 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.

HOW SUPPLIED

Product: 50090-4357

NDC: 50090-4357-0 35.4 g in a TUBE / 1 in a CARTON

Menthol and Methyl Salicylate

INGREDIENTS AND APPEARANCE

ICY HOT  PAIN RELIEVING CREAM
menthol and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-4357(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: 50090-4357-0	1 in 1 CARTON	06/14/2019
1		35.4 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 - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-4357)