The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Icy Hot With Lidocaine No-mess (NDC 41167-1715). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding purposes, use, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Lidocaine HCl 4%............................................................................................................................Topical anesthetic
Menthol 1%.......................................................................................................................................Topical analgesic
temporarily relieves minor pain
For external use only
■ 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
■ 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
■ 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
ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away.
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
alcohol denat. (40%), aminomethyl propanol, citric acid, glycerin, hydroxypropyl methylcellulose, water
ICY HOT
LIDOCAINE
Plus Menthol
NO MESS
Applicator
NET WT 2.5 oz (70.8 g)
Principal Display Panelicy Hotlidocaineplus Mentholno Messapplicatornet Wt 2.5 Oz (70.8 G) (Icy Hot With Lidocaine No Mess Applicator 01)
* Please review the disclaimer below.
