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Lidocaine Patch
Lidocaine Patch
FDA Label NDC 81484-901
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Anhui Miao De Tang Pharmaceutical Co., Ltd. for the product Lidocaine Patch (NDC 81484-901). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Lidocaine 4%,Menthol 1%
Otc - Purpose
For the temporary relief of palin
Indications & Usage
For the temporary relief of palin, TOPICAL ANESTHETIC
Warnings
For external use only
Otc - Do Not Use
more than 1 patch on your body at a time or on cut, irritated or swollen skin
Otc - When Using
use only as directod. Read and follow all directions and warnings on this label.
rare cases of serious bums have been reported with products of this type
do not apply to wounds or damaged, broken or irritated skin
do not allow contact with the eyes and mucous membranes
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
Otc - Stop Use
condition worsens
rodness is present
irritation develops
symptoms persist for more than 7 days or clear up and occur again within a few days
you experience sians ot skin injury, such as pain, swelling, or blistering where the product was applied
Otc - Keep Out Of Reach Of Children
it swallowed, get medical help or contact Poison Control Center right away.
Dosage & Administration
Adults and children 12 years of age and over:
clean and dry aftecied area
remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
carefully remave smaller portion of backing from patch and apply exposed portion of patch to atlected area
once exposed portion of patch is positioned, carefully remove remaining backing to completely applypatch to aitected area
use 2 patch tor up to 24 hours
Children under 12 years of age:consult a doctor
Storage And Handling
Store in a clean, dry place outside of direct sunlight. Protect product from excessive moisture.
Inactive Ingredient
Aluminum Glycinate
Aluminum Hydroxide
Cellulose Gum
Glycerin
Methylparaben
PEG-40 Hydrogenated Castor Oil
Polyacrylic Acid
Polysorbate 80
Propylene Glycol
Ricinus Communis Seed Oil (Castor)
Silica
Sodium Polyacrylate
Tartaric Acid
Titanium Dioxide
Urea
Water
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Label (14)
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