Otc - Active Ingredient
Lidocaine 4%
Kingly 4% Lidocaine Patches Patch
FDA Label NDC 87394-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Huayuan Hengsheng Technology Co., Ltd. for the product Kingly 4% Lidocaine Patches (NDC 87394-002). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical analgesic
Indications & Usage
For temporary relief of pain
Warnings
For external use only
Otc - 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
Otc - When Using
use only as directed
avoid contact with the eyes, mucous membranes or rashes
do not bandage tightly
Otc - 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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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
Inactive Ingredient
Aluminum Glycinate
Disodium EDTA
Ethylhexylglycerin
Glycerin
Phenoxyethanol
Polyvinyl pyrrolidone
Polysorbate 80
Sodium carboxymethyl cellulose
Sodium polyacrylate
Sorbitol
Tartaric Acid
Titanium Dioxide
Water
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Label (Label)
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