FDA Label for Lidocaine Pain Relief Patch
View Indications, Usage & Precautions
Lidocaine Pain Relief Patch Product Label
The following document was submitted to the FDA by the labeler of this product Henan Enokon Medical Instrument Co., Ltd.. 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
Lidocaine 4%
Purpose
Topical analgesic
Use
For temporary relief of pain
Warnings
For external use only
Do Not Use
more than 1 patch at a time
on wounds or damaged skin
with a heating pad
if you have ever had an allergic reaction to this product or any of its ingredients
When Using
use only as directed
avoid contact with the eyes, mucous membranes or rashes
do not bandage tightly
Stop Use
localized skin reactions occur, such as rash, itching, redness, irritation, pain swelling and blistering conditions worsen
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
Ask Doctor
If pregnant or breast-feeding, ask a health professional before use.
Children under 12 years of age: consult a doctor
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 over
clean and dry affected area
remove film from patch and apply to the skin (see illustration)
apply 1 patch at a time to affected area, not more than 3 to 4 times daily
remove patch from the skin after at most 8 hours of application
Children under 12 years of age: consult a doctor
Other Information
avoid storing product in direct sunlight
protect product from excessive moisture
store at 20-25°C(68-77°F)
Inactive Ingredients
Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Kaolin, Phenoxyethanol, Polyvinylpyrrolidone, Propylene Glycol, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Tartaric Acid, Water
Questions
1-800-910-6874
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