Otc - Active Ingredient
Lidocaine 4%
4% Lidocaine Pain Relief Patch
FDA Label NDC 87278-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangxi Keyun E-commerce Co., Ltd. for the product 4% Lidocaine Pain Relief Patch (NDC 87278-003). 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 anesthetic
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 are allergic to any ingredients of this product
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
condition 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
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adult 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-hour application
Children under 12 years of age: consult a doctor
Inactive Ingredient
Glycerin
Dihydroxyaluminum aminoacetate anhydrous
Edetate disodium
Tartaric acid
Povidone K90
DMDM Hydantoin
Polysorbate 80
Propylene glycol
Carboxymethylcellulose sodium
Kaolin
Carbomer
Sodium polyacrylate
Water
Package Label.Principal Display Panel
Label (Label)
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