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 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
* Please review the disclaimer below.