Active Ingredient
Lidocaine 4.0%
Purpose
Topical anesthetic
Arthcal 4% Lidocaine Patches Patch
FDA Label NDC 85212-0004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beijing Junge Technology Co., Ltd. for the product Arthcal 4% Lidocaine Patches (NDC 85212-0004). 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 active ingredient, use, warnings, directions, other information, inactive ingredients, questions?, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
For temporary relief of pain
Warnings
For external use only
Do not use
more than 1 patch at a time
with a heating pad
on wounds or damaged skin
ir you are allergic to any ingredients of this product
When using this product
use only as directed
do not bandage tightly
avoid contact with the eyes, mucous membranes or rashes
Stop use and ask a doctor if
symptoms persist for more than 7 days
conditions worsen
symptoms clear up and occur again within a few days
localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop
If pregnant or breast feeding,
ask a health professional before use
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
apply 1 patch at a time to affected area, not more than 3 to 4 times daily
remove film from patch and apply to the skin
Children under 12 years of age: consult a doctor
Other Information
store in a clean, dry place outside of direct sunlight, Protect product from excessive moisture
Inactive Ingredients
Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone K90, Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
Questions?
1-888-655-1558
Package Label.Principal Display Panel
4% Lidocaine Patches (20250217 160838)
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