Active Ingredients
Lidocaine 4%
Menthol 1%
Icy Hot With Lidocaine Patch
FDA Label NDC 41167-1720
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Icy Hot With Lidocaine (NDC 41167-1720). 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 active ingredients, purposes, use, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Topical anesthetic
Topical analgesic
Use
temporarily relieves minor pain
Warnings
For external use only
Do Not Use
■ more than 1 patch on your body at a time or on cut, irritated or swollen skin
■ on puncture wounds
■ for more than one week without consulting a doctor
When Using This Product
■ avoid contact with the eyes and mucous membranes
■ use only as directed. Read and follow all directions and warnings on this carton/label.
■ 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) to the area of use
■ do not use at the same time as other topical analgesics
■ a transient burning sensation may occur upon application but generally disappears in several days
■ if severe burning sensation occurs, discontinue use immediately
■ dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
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 And Pets.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
adults and children over 12 years:
■ clean and dry affected area
■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
■ use 1 patch for up to 12 hours
children 12 years or younger: ask a doctor
Inactive Ingredients
aluminum glycinate, aluminum hydroxide, cellulose gum, glycerin, methylparaben, PEG-40 hydrogenated castor oil, polyacrylic acid, polysorbate 80, propylene glycol, ricinus communis (castor) seed oil, silica, sodium polyacrylate, tartaric acid, titanium dioxide, urea, water
Child-resistant packaging.
Keep carton as it contains important information.
Principal Display Panel
ICYHOT
LIDOCAINE PATCH
PLUS MENTHOL
Principal Display Panelicyhotlidocaine Patchplus Menthol (Icy Hot With Lidocaine Patch 01)
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