Label: ICY HOT PRO PAIN RELIEF CREAM W/ MICROBEADS- menthol, camphor cream

  • NDC Code(s): 41167-0078-0, 41167-0078-2
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

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  • SPL UNCLASSIFIED SECTION

    ICY HOT PRO CREAM

    Drug Facts

  • Active ingredients

  • Purpose

    Camphor 11%, Menthol 16%...........................................................................................................Topical analgesic

  • Uses

    temporarily relieves minor aches and pains of muscles and joints associated with: ■ arthritis ■ simple backache ■ strains ■ sprains ■ bruises

  • Warnings

    For external use only

    Do not use

    ■ on wounds or on irritated or damaged skin

    ■ with a heating pad

    When using this product

    ■ use only as directed

    ■ do not bandage tightly

    ■ avoid contact with eyes and mucous membranes

    ■ do not expose the area to local heat or direct sunlight

    ■ rare cases of serious burns have been reported with products of this type

    ■ a transient burning sensation may occur upon application but generally disappears in several days

    ■ avoid applying into skin folds

    Stop use and ask a doctor if

    ■ condition worsens or symptoms persist for more than 7 days

    ■ symptoms clear up and occur again within a few days

    ■ redness is present or excessive skin irritation occurs

    ■ you experience severe burning 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 12 years of age and older:
      ▪ apply a thin layer to affected area not more than 3 to 4 times daily
      ▪ massage until thoroughly absorbed into skin
      ▪ wash hands thoroughly with soap and water after each use
    • children under 12 years of age: ask a doctor
  • Inactive ingredients

     

    water, propanediol, steareth-21, alcohol denat., glyceryl stearate, cetyl alcohol, farnesol, stearic acid, aloe barbadensis leaf juice, acrylates/C10-30 alkyl acrylate crosspolymer, menthyl lactate, jojoba esters, diisopropyl adipate, pentylene glycol, 4-t-butylcyclohexanol, potassium hydroxide, allantoin, fragrance, citrus paradisi (grapefruit) peel oil, mentha piperita (peppermint) oil, mentha viridis (spearmint) leaf oil, ethoxydiglycol, glyceryl dilaurate, polysorbate 80, PEG-150 stearate, glycine soja (soybean) sterols, phenoxyethanol, methylparaben, glycerin, disodium EDTA, xanthan gum, ferric ferrocyanide, citric acid

    357-102

    Close cap tightly after use.

    Keep carton as it contains important information.

  • PRINCIPAL DISPLAY PANEL

    IcyHot
    Pro Pain Relief Cream
    Net Wt 2 OZ (56 g)

    PRINCIPAL DISPLAY PANEL IcyHot Pro Pain Relief Cream Net Wt 2 OZ (56 g)

  • INGREDIENTS AND APPEARANCE
    ICY HOT PRO PAIN RELIEF CREAM W/ MICROBEADS 
    menthol, camphor cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0078
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.16 g  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.11 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    STEARETH-21 (UNII: 53J3F32P58)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    FARNESOL (UNII: EB41QIU6JL)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    FERRIC FERROCYANIDE (UNII: TLE294X33A)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PEG-150 STEARATE (UNII: 7BSG7DF10Q)  
    SOY STEROL (UNII: PL360EPO9J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0078-056 g in 1 TUBE; Type 0: Not a Combination Product02/21/2022
    2NDC:41167-0078-228 g in 1 TUBE; Type 0: Not a Combination Product06/12/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/21/2022
    Labeler - Chattem, Inc. (003336013)
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