Label: ICY HOT ADVANCED RELIEF- menthol topical analgesic patch

  • 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 November 9, 2012

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

View All SectionsClose All Sections
  • Active Ingredient

    Menthol 7.5%

    Close
  • Purpose

    Topical analgesic

    Close
  • Uses

    Temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
    • cramps
    Close
  • Warnings

    For external use only

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin
    • do not use at the same time as other topical analgesics

    Stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant of 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.

    Close
  • Directions

    adults and children over 12 years:

    • gently fold the path 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
    • use 1 patch for up to 12 hours, once a day

    Children 12 years and younger: ask a doctor

    Close
  • Inactive ingredients

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

    Close
  • 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

    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

    Close
  • INGREDIENTS AND APPEARANCE
    ICY HOT ADVANCED RELIEF 
    menthol topical analgesic patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0805
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 210 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0805-0 1 in 1 CARTON
    1 4 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 12/01/2012
    Labeler - Chattem, Inc. (003336013)
    Close
View All SectionsClose All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Label Archives, RxNorm, Get Label RSS Feed