ICY HOT PAIN RELIEVING CREAM- menthol and methyl salicylate cream 
A-S Medication Solutions

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

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.





HOW SUPPLIED

Product: 50090-4357

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

Menthol and Methyl Salicylate

Label Image
ICY HOT  PAIN RELIEVING CREAM
menthol and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4357(NDC:41167-0088)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ESTERS WAX (UNII: D072FFP9GU)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-4357-01 in 1 CARTON06/14/2019
135.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34806/01/1991
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-4357)

Revised: 6/2019
Document Id: d4614dfc-8ed1-44a4-a777-299530abc5dd
Set id: fbe6178e-569d-42b1-80e1-3541b7cdb71c
Version: 1
Effective Time: 20190625
 
A-S Medication Solutions