FDA Label for Icy Hot Original Foam

View Indications, Usage & Precautions

Icy Hot Original Foam 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.

Purpose



Menthol 16%......................................................................................................................................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    

Flammable

■ keep away from heat and open flame


Do Not Use



■ on wounds, damaged, broken or irritated skin

■ with a heating pad


When Using This Product



■ use only as directed

■ do not bandage tightly

■ do not expose the area to local heat or to direct sunlight

■ 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

■ avoid contact with the eyes and mucous membranes


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

■ 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:

■ pump slowly and apply to the affected area not more than 3 to 4 times daily

■ wash hands thoroughly with soap and water after each use

children under 12 years of age:  consult a doctor


Inactive Ingredients



alcohol denat. (50%), bis-PEG-8 dimethicone, bis-PEG-12 dimethicone, propylene glycol, water


Principal Display Panel



ICY HOT
ORIGINAL

PAIN RELIEF

FOAM

MENTHOL 16%

4 FL OZ (118 mL)


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