Label: ICY HOT ADVANCED RELIEF- menthol topical analgesic patch

  • NDC Code(s): 41167-0805-0, 41167-0805-1
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredient

    Menthol 7.5%

  • Purpose

    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

    Do not use

    ■ on wounds, damaged, broken or irritated skin

    ■ with a heating pad or apply local heat to the area of use

    When using this product

    ■ use only as directed

    ■ do not bandage tightly

    ■ avoid contact with eyes and mucous membranes

    ■ 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

    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

    ■ you 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:

    ■ gently fold the patch in half to remove center section of film backing. Apply the exposed adhesive portion to the site of pain.

    ■ remove remaining film backing from both sides and finish applying to skin

    ■ apply to affected area not more than 3 to 4 times daily

    children under 12 years of age: consult a doctor

  • Inactive ingredients

    glyceryl hydrogenated rosinate, hydrated silica, mineral oil, PEG-400, polyisobutene, styrene/isoprene copolymer

  • Principal Display Panel

    ICY HOT®
    ADVANCED RELIEF
    PAIN RELIEF PATCH
    ADVANCED RELIEF at the POINT of PAIN
    50% MORE MEDICINE
    LONG LASTING RELIEF
    FLEXIBLE, NO MESS FABRIC
    Easy to Apply and Remove
    Contains 4 Patches in 1 Resalable Pouch
    3 15/16” x 5 ½” (10 cm x 14 cm) each

    Principal Display Panel ICY HOT® ADVANCED RELIEF PAIN RELIEF PATCH ADVANCED RELIEF at the POINT of PAIN 50% MORE MEDICINE LONG LASTING RELIEF FLEXIBLE, NO MESS FABRIC Easy to Apply and Remove Contains 4 Patches in 1 Resalable Pouch 3 15/16” x 5 ½” (10 cm x 14 cm) each

  • INGREDIENTS AND APPEARANCE
    ICY HOT ADVANCED RELIEF 
    menthol topical analgesic patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL210 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    GLYCEROL ESTER OF HYDROGENATED ROSIN (UNII: XH62RP786N)  
    STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0805-01 in 1 CARTON12/01/201203/31/2017
    14 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:41167-0805-15 in 1 CARTON; Type 0: Not a Combination Product10/22/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/01/2012
    Labeler - Chattem, Inc. (003336013)
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