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.

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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:

  • 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. Read and follow all directions and warnings on this label.

■ avoid contact with eyes and mucous membranes

■ rare cases of serious burns have been reported with products of this type

■ do not apply to wounds or damaged, broken or irritated skin

■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

■ a transient burning sensation may occur upon application but generally disappears in several days

■ if severe burning sensation occurs, discontinue use immediately

■ do not expose the area treated with product to heat or direct sunlight

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 a thin layer 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. Read and follow all directions and warnings on this label.

■ avoid contact with eyes and mucous membranes

■ rare cases of serious burns have been reported with products of this type

■ do not apply to wounds or damaged, broken or irritated skin

■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

■ do not use at the same time as other topical analgesics

■ a transient burning sensation may occur upon application but generally disappears in several days

■ if severe burning sensation occurs, discontinue use immediately

■ do not expose the area treated with product to heat or direct sunlight

■ avoid applying into skin folds

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

■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding,

ask a health 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 a thin layer to affected area

■ massage into painful area until thoroughly absorbed into skin

■ repeat as necessary, but no more than 4 times daily

■ AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

children 12 years or younger: ask a doctor

Inactive ingredients

paraffin, white petrolatum






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. Read and follow all directions and warnings on this carton.

■ avoid contact with eyes and mucous membranes

■ rare cases of serious burns have been reported with products of this type

■ do not apply to wounds or damaged, broken or irritated skin

■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

■ do not use at the same time as other topical analgesics

■ a transient burning sensation may occur upon application but generally disappears in several days

■ if severe burning sensation occurs, discontinue use immediately

■ do not expose the area treated with product to heat or direct sunlight

■ avoid applying into skin folds

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

■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding,

ask a health 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 a thin layer to affected area

■ massage into painful area until thoroughly absorbed into skin

■ repeat as necessary, but no more than 4 times daily

■ AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

children 12 years or younger: ask a doctor

Inactive ingredients

carbomer, cetearyl alcohol, cetyl esters, oleth-3 phosphate, polysorbate 60, stearic acid, triethanolamine, water

Close cap tightly after use.

HOW SUPPLIED

Product: 50090-4357

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 CARTON06/14/201909/30/2022
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 finalpart34806/01/199109/30/2022
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-4357)

Revised: 2/2023
Document Id: 591c2256-a5df-4735-8f7e-464be8892a41
Set id: fbe6178e-569d-42b1-80e1-3541b7cdb71c
Version: 5
Effective Time: 20230204
 
A-S Medication Solutions