FDA Label for Icy Hot Advanced Relief

View Indications, Usage & Precautions

Icy Hot Advanced Relief Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Menthol 16%

Camphor 11%


Purpose



Topical analgesic


Uses



Temporarily relieves minor pain associated with:

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

Warnings



For external use only


When Using This Product



  • use only as directed
  • do not bandage tightly or use with a heating pad, or medicated patch
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears within a few days 

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.


Directions



adults and children over 12 years:

  • apply a thin layer to affected area
  • message into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 3 to 4 times daily, allowing a minimum of 2-3 hours between applications
  • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER
  • Children 12 years and younger: ask a doctor


Inactive Ingredients



acrylates/C10-30 alkyl acrylate crosspolymer,  allantoin, aloe barbadensis leaf juice, cetyl alcohol, diisopropyl adipate, disodium EDTA, ethoxydiglycol, fragrance, glycerin, glyceryl stearate, menthyl lactate, methylparaben, PEG-150 sterate, pentylene glycol, 4-t-butylcyclohexanol, phenoxyethanol, polysorbate 80, propanediol, SD alcohol (5% w/w), glycine soja (soybean) sterols, steareth-21, stearic acid, triethanolamine, water, xanthan gum (309-018)


Principal Display Panel



ICY HOT®
ADVANCED
PAIN RELIEF CREAM
Net WT 2 OZ (56 g)


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