Label: 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

  • NDC Code(s): 41167-0087-9, 41167-0088-1, 41167-0088-5, 41167-0088-8, view more
    41167-0089-8
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 March 30, 2021

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  • 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. 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.

  • 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 STICK
EXTRA STRENGTH
Net wt 1.75 oz (49 g)

  • PRINCIPAL DISPLAY PANEL

    ICYHOT® PAIN RELIEVING BALM
    Net
    wt 3.5 oz (99.2 g)

    PRINCIPAL DISPLAY PANEL
ICYHOT® PAIN RELIEVING BALM
Net wt 3.5 oz (99.2 g)
 PRINCIPAL DISPLAY PANEL
ICYHOT® PAIN RELIEVING BALM
Net wt 3.5 oz (99.2 g)


  • PRINCIPAL DISPLAY PANEL

    ICYHOT® PAIN RELIEVING CREAM
    Net wt
    1.25 oz (35.4 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0089
    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
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0089-849 g in 1 JAR; Type 0: Not a Combination Product06/01/1991
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/1991
    ICY HOT  PAIN RELIEVING BALM
    menthol and methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0087
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.6 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE29 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0087-999 g in 1 JAR; Type 0: Not a Combination Product06/01/1991
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/1991
    ICY HOT  PAIN RELIEVING CREAM
    menthol and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:41167-0088-11 in 1 CARTON06/01/1991
    185 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:41167-0088-51 in 1 CARTON06/01/1991
    235.4 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:41167-0088-81 in 1 CARTON06/01/1991
    344 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 - Chattem, Inc. (003336013)