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
  • 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 March 29, 2021

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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 not finalpart34812/01/2012
    Labeler - Chattem, Inc. (003336013)
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