Label: ICY HOT ORIGINAL FOAM- menthol liquid

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

Drug Label Information

Updated October 24, 2023

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  • SPL UNCLASSIFIED SECTION

    ICY HOT FOAM

    (MENTHOL 16%)

    Drug Facts

  • Active ingredient

  • Purpose

    Menthol 16%......................................................................................................................................Topical analgesic

  • Uses

    for the temporary relief of minor aches and pains of muscles and joints associated with:

    ■ arthritis    ■ simple backache    ■ strains    ■ sprains ■ bruises

  • Warnings

    For external use only    

    Flammable

    ■ keep away from heat and open flame

    Do not use

    ■ on wounds, damaged, broken or irritated skin

    ■ with a heating pad

    When using this product

    ■ use only as directed

    ■ do not bandage tightly

    ■ do not expose the area to local heat or to 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 contact with the eyes and mucous membranes

    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

    ■ severe burning sensation, redness or irritation develop

    ■ experience signs of skin injury, such as 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:

    ■ pump slowly and apply to the affected area not more than 3 to 4 times daily

    ■ wash hands thoroughly with soap and water after each use

    children under 12 years of age:  consult a doctor

  • Inactive ingredients

    alcohol denat. (50%), bis-PEG-8 dimethicone, bis-PEG-12 dimethicone, propylene glycol, water

  • PRINCIPAL DISPLAY PANEL

    ICY HOT
    ORIGINAL
    PAIN RELIEF
    FOAM
    MENTHOL 16%
    4 FL OZ (118 mL)

    ICY HOT ORIGINAL PAIN RELIEF FOAM MENTHOL 16% 4 FL OZ (118 mL)

  • INGREDIENTS AND APPEARANCE
    ICY HOT ORIGINAL FOAM 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL140.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    BIS-PEG-12 DIMETHICONE (500 MPA.S) (UNII: 2CNS542YRT)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0090-1118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/15/2021
    Labeler - Chattem, Inc. (003336013)
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