Label: ICY HOT ORIGINAL FOAM- menthol liquid

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 January 18, 2021

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

  • 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)

    PRINCIPAL DISPLAY PANEL
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 NOT FINALpart34801/15/2021
    Labeler - Chattem, Inc. (003336013)