Label: ICY HOT PAIN RELIEVING CREAM- menthol and methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated June 25, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    ICYHOT® PAIN RELIEVING STICK
    Drug Facts

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  • Active ingredient

    Menthol 10%

    Methyl salicylate 30%

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  • Purpose

    Topical analgesic

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  • Uses

    temporarily relieves minor pain associated with:

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

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  • 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

    Close
  • 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

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  • Active ingredient

    Menthol 7.6%

    Methyl salicylate 29%

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  • Purpose

    Topical analgesic

    Close
  • Uses

    temporarily relieves minor pain associated with:

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

    Close
  • 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

    Close
  • Inactive ingredients

    paraffin, white petrolatum (245-109)




    ICYHOT® PAIN RELIEVING CREAM
    Drug Facts

    Close
  • Active ingredient

    Menthol 10%

    Methyl salicylate 30%

    Close
  • Purpose

    Topical analgesic

    Close
  • Uses

    temporarily relieves minor pain associated with:

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

    Close
  • 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

    Close
  • Inactive ingredients

    carbomer, cetyl esters, emulsifying wax, oleth-3 phosphate, stearic acid, triethanolamine, water (245-110)

    Close cap tightly after use.





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  • HOW SUPPLIED

    Product: 50090-4357

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

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  • 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)
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