Label: ICY HOT PRO PAIN MASSAGING BALM- camphor and menthol cream

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

Drug Label Information

Updated February 19, 2024

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  • SPL UNCLASSIFIED SECTION

    Icy Hot PRO Pain Relief Massaging Balm

    Drug Facts

  • Active ingredient                                                

    Camphor 11% 

    Menthol 16%

  • Purpose

    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. 

    This product is not a toy or intended for use by children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 12 years of age and older:
      • massage into affected area using the no-mess balm not more than 3 to 4 times daily
      • wash hands thoroughly with soap and water if product comes in contact with hands

    • children under 12 years of age: ask a doctor
  • Inactive ingredients

    prunus amygdalus dulcis (sweet almond) oil, helianthus annuus (sunflower) seed wax, theobroma cacao (cocoa) seed butter, cocos nucifera (coconut) oil, persea gratissima (avocado) oil, hydrogenated vegetable oil, copernicia cerifera (carnauba) wax, synthetic beeswax, citrus paradisi (grapefruit) peel oil, eucalyptus globulus leaf oil, mentha piperita (peppermint) oil, mentha viridis (spearmint) leaf oil

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

    Keep carton as it contains important information. 

         

  • PRINCIPAL DISPLAY PANEL

    ICY HOT Pro Pain Relief

    Massaging Balm
    NET WT 1.25 OZ (35 g)

    A blue box with white text and blue text Description automatically generated

  • INGREDIENTS AND APPEARANCE
    ICY HOT PRO PAIN MASSAGING BALM 
    camphor and menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0790
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.16 g  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC).11 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    HYDROGENATED AVOCADO OIL (UNII: JA69U4B4XI)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0790-01 in 1 CARTON01/15/2024
    135 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/15/2024
    Labeler - Chattem, Inc. (003336013)
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