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Icy Hot (Chattem, Inc.)

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OINTMENT 99 g in 1 JAR (41167-0087-9) Label Information

Complete Icy Hot Information

  • 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.






  • 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
    EXTRA STRENGTH

    Net wt 3.5 oz (99.2 g)

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


  • PRINCIPAL DISPLAY PANEL

    ICYHOT® PAIN RELIEVING CREAM
    Net wt
    1.25 oz (35.4 g)
    EXTRA STRENGTH

    PRINCIPAL DISPLAY PANEL
ICYHOT® PAIN RELIEVING CREAM
Net wt 1.25 oz (35.4 g)
EXTRA STRENGTH


  • INGREDIENTS AND APPEARANCE
    ICY HOT 
    menthol and methyl salicylate stick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0089
    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) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 30 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0089-8 49 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 06/01/1991
    ICY HOT 
    menthol and methyl salicylate ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0087
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 7.6 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 29 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0087-9 99 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 06/01/1991
    ICY HOT 
    menthol and methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) 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) (METHYL SALICYLATE - UNII:LAV5U5022Y) 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:41167-0088-1 1 in 1 CARTON
    1 85 g in 1 TUBE
    2 NDC:41167-0088-5 1 in 1 CARTON
    2 35 g in 1 TUBE
    3 NDC:41167-0088-8 1 in 1 CARTON
    3 44 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 06/01/1991
    Labeler - Chattem, Inc. (003336013)
    Establishment
    Name Address ID/FEI Business Operations
    Chattem Plant 1 003336013 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Chattem Plant 2 830410721 MANUFACTURE