Other
Lidocaine Patch
Lidocaine Patch
FDA Label NDC 84273-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hunan En Pu Pharmaceutical Co., Ltd. for the product Lidocaine Patch (NDC 84273-002). 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 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
Topical Anesthetic
Indications & Usage
For the temporary relief of minor aches and pains of muscles and joints
Warnings
For external use only
Otc - Do Not Use
use only as directed
avoid contact with eyes
do not apply to wounds or damaged skin
do not bandage tightly or apply any other heating pads to the affected area
Otc - When Using
use only as directed
avoid contact with eyes
do not apply to wounds or damaged skin
do not bandage tightly or apply any other heating pads to the affected area
Otc - Stop Use
if condition worsens
if symptoms clear up and occur again within a few days
if redness and irritation develop
if symptoms persist for more than 7 days, consult a doctor
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Dosage & Administration
Adults and children 2 years of age and older
clean and dry affected area
remove backing trom patch and firmly grasp both ends, gently pull backing until it separates up to the middle
slowly apply the patch to the affected area and gently remove any remaining backing from the patch
apply to affected area not more than 3 to 4 times daily
Storage And Handling
Store in a clean, and dry place outside of direct sunlight.
Inactive Ingredient
Aluminum Glycinate
Aluminum Hydroxide
Cellulose Gum
DMDM hydantoin
Glycerin
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
Package Label.Principal Display Panel
Label2 (Label2)
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