Label: ICY HOT ADVANCED RELIEF- camphor and menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Menthol 16%

    Camphor 11%

  • 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, or medicated patch
    • 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 within a few days 

    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 of 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
    • message into painful area until thoroughly absorbed into skin
    • repeat as necessary, but no more than 3 to 4 times daily, allowing a minimum of 2-3 hours between applications
    • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

    Children 12 years and younger: ask a doctor

  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer,  allantoin, aloe barbadensis leaf juice, cetyl alcohol, diisopropyl adipate, disodium EDTA, ethoxydiglycol, fragrance, glycerin, glyceryl stearate, menthyl lactate, methylparaben, PEG-150 sterate, pentylene glycol, 4-t-butylcyclohexanol, phenoxyethanol, polysorbate 80, propanediol, SD alcohol (5% w/w), glycine soja (soybean) sterols, steareth-21, stearic acid, triethanolamine, water, xanthan gum (309-018)

  • Principal Display Panel

    ICY HOT®
    ADVANCED
    PAIN RELIEF CREAM
    Net WT 2 OZ (56 g)

    Principal Display Panel ICY HOT® ADVANCED PAIN RELIEF CREAM Net WT 2 OZ (56 g)

  • INGREDIENTS AND APPEARANCE
    ICY HOT ADVANCED RELIEF 
    camphor and menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.11 g  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-150 STEARATE (UNII: 7BSG7DF10Q)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SOY STEROL (UNII: PL360EPO9J)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0801-01 in 1 CARTON12/01/2012
    156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/01/2012
    Labeler - Chattem, Inc. (003336013)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHATTEM, INC.830410721analysis(41167-0801) , label(41167-0801) , manufacture(41167-0801) , pack(41167-0801)
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