Label: ICY HOT ADVANCED RELIEF- camphor (synthetic) and menthol cream 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients

    Menthol 16%

    Camphor 11%

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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

    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.

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  • 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

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  • 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)

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  • Principal Display Panel

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

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

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  • INGREDIENTS AND APPEARANCE
    ICY HOT ADVANCED RELIEF 
    camphor and menthol cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41167-0801
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 0.11 g  in 1 g
    MENTHOL (MENTHOL) MENTHOL 0.16 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALLANTOIN  
    ALOE VERA LEAF  
    CETYL ALCOHOL  
    DIISOPROPYL ADIPATE  
    EDETATE DISODIUM  
    DIETHYLENE GLYCOL MONOETHYL ETHER  
    GLYCERIN  
    GLYCERYL MONOSTEARATE  
    MENTHYL LACTATE, (-)-  
    METHYLPARABEN  
    PEG-150 STEARATE  
    PENTYLENE GLYCOL  
    4-TERT-BUTYLCYCLOHEXANOL  
    PHENOXYETHANOL  
    POLYSORBATE 80  
    PROPANEDIOL  
    SOY STEROL  
    STEARETH-21  
    STEARIC ACID  
    TROLAMINE  
    WATER  
    XANTHAN GUM  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0801-0 1 in 1 CARTON
    1 56 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 12/01/2012
    Labeler - Chattem, Inc. (003336013)
    Establishment
    Name Address ID/FEI Business Operations
    Chattem Plant 2 830410721 ANALYSIS(41167-0801), LABEL(41167-0801), MANUFACTURE(41167-0801), PACK(41167-0801), RECOVERY(41167-0801), RELABEL(41167-0801), REPACK(41167-0801)
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