Label: ICY HOT PRO DRY- camphor, menthol spray

  • 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 DRY SPRAY 

    Drug Facts

  • Active ingredients

  • Purpose

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

  • Use

    temporarily relieves minor aches and pains of muscles and joints associated with:

    ■ arthritis     ■ simple backache     ■ strains  ■ sprains     ■ bruises                                

  • Warnings

    For external use only

    Extremely flammable: keep away from fire, sparks, and heated surfaces. Contents under pressure, do not puncture or incinerate container. Exposure to temperatures above 120°F may cause bursting.

    Do not use

    ■ on wounds or on irritated or damaged skin

    ■ with a heating pad

    When using this product

    ■ use only as directed. Intentional misuse by deliberately concentrating or inhaling the contents can be harmful or fatal.

    ■ do not bandage tightly

    ■ avoid contact with eyes and mucous membranes. Do not spray in face or mouth.

    ■ 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:
      ▪ spray the affected area not more than 3 to 4 times daily
      ▪ product will dry quickly on its own, and does not need to be rubbed in
      ▪ wash hands thoroughly with soap and water after each use
    • children under 12 years of age: ask a doctor
  • Inactive ingredients:

    alcohol denat., glycerin, isobutane, propylene glycol, water

                                                                                  357-097

  • PRINCIPAL DISPLAY PANEL

    ICY HOT
    PRO
    Pain Relief

    DRY SPRAY
    NET WT 4 oz (113g)

    PRINCIPAL DISPLAY PANEL ICYHOT PRO Pain Relief DRY SPRAY NET WT 4 oz (113g)

  • INGREDIENTS AND APPEARANCE
    ICY HOT PRO DRY 
    camphor, menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)11 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0080-4118 mL in 1 CAN; Type 0: Not a Combination Product02/21/2022
    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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