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Icy Hot Naturals (Chattem, Inc.)

Available Formats

Dosage Form Package Information Links
CREAM 1 TUBE in 1 CARTON (41167-0093-8) > 70.8 g in 1 TUBE Label Information
CREAM 14.1 g in 1 TUBE (41167-0093-7) Label Information
CREAM 2.8 g in 1 POUCH (41167-0093-6) Label Information

Complete Icy Hot Naturals Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    Menthol 7.5%


  • Purpose

    Topical analgesic


  • Uses

    temporarily relieves minor pain associated with:

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

  • Warnings

    For external use only

    When using this product
    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin
    • 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 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 1 years:

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary, but no more than 3 to 4 times daily
    • WASH HANDS WITH SOAP AND WATER AFTER APPLYING

    children 12 years or younger: ask a doctor


  • Inactive ingredients

    aloe barbadensis leaf juice, beeswax, benzyl alcohol, capsaicin, cetearyl alcohol, cetyl alcohol, cetyl esters, cetyl palmitate, citrus paradise (grapefruit) peel oil, di-PEG-2 soyamine IPDI, disodium EDTA, distearyldimonium chloride, eucalyptus globules leaf oil, glycerin, hydrogenated olive oil, jojoba esters, melaleuca alternifolia (tea tree) leaf oil, menthe viridis (spearmint) leaf oil, olea europaea (olive) fruit oil, olea europaea (olive) oil unsaponifiables, polysorbate 60, potassium hydroxide, propanediol, sorbitan olivate, sorbitan palmitate, steareth-2, steareth-21, stearyl alcohol, water (283-109)

    Close cap tightly after use. Keep carton as it contains important information about this product.


  • PRINCIPAL DISPLAY PANEL

    ICYHOT® NATURALS
    pain relief cream
    MENTHOL 7.5%
    Net wt 2.5 oz (70.8 g)

    PRINCIPAL DISPLAY PANEL
ICYHOT® NATURALS
pain relief cream
MENTHOL 7.5%
Net wt 2.5 oz (70.8 g)


  • INGREDIENTS AND APPEARANCE
    ICY HOT NATURALS 
    menthol cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0093
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.075 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    GRAPEFRUIT PEEL (UNII: 3582N05Q44)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    CORYMBIA CITRIODORA LEAF OIL (UNII: M63U6N96EB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    TEA LEAF (UNII: GH42T47V24)  
    SPEARMINT (UNII: J7I2T6IV1N)  
    FRUIT (UNII: C2AIY4ERZC)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0093-8 1 in 1 CARTON
    1 70.8 g in 1 TUBE
    2 NDC:41167-0093-6 2.8 g in 1 POUCH
    3 NDC:41167-0093-7 14.1 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 12/01/2010
    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
    Establishment
    Name Address ID/FEI Business Operations
    Span Packaging Services 557434805 PACK