FDA Label for Icy Hot With Lidocaine No-mess

View Indications, Usage & Precautions

Icy Hot With Lidocaine No-mess 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.

Purposes



Lidocaine HCl 4%............................................................................................................................Topical anesthetic

Menthol 1%.......................................................................................................................................Topical analgesic


Use



temporarily relieves minor pain


Warnings



For external use only


Do Not Use



 on large areas of the body or on cut, irritated or swollen skin

 on puncture wounds

 for more than one week without consulting a doctor


When Using This Product



 use only as directed. Read and follow all directions and warnings on this carton.

■ avoid contact with eyes and mucous membranes

 rare cases of serious burns have been reported with products of this type

■ do not apply to wounds or damaged, broken or irritated skin

■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

■ a transient burning sensation may occur upon application but generally disappears in several days

 avoid applying into skin folds


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

■ 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 over 12 years:

■ apply a thin layer to affected area not more than 3 to 4 times daily

■ massage into painful area until thoroughly absorbed into skin

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 12 years or younger: ask a doctor


Inactive Ingredients



alcohol denat. (40%), aminomethyl propanol, citric acid, glycerin, hydroxypropyl methylcellulose, water


Principal Display Panel



ICY HOT
LIDOCAINE
Plus Menthol
NO MESS

Applicator
NET WT 2.5 oz (70.8 g)


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