Active Ingredient
Lidocaine 4.0%
Lidocaine 4% Patch
FDA Label NDC 55154-7813
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Lidocaine 4% (NDC 55154-7813). 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, purpose, indications and usage, warnings, do not use, when using this product, stop use and consult a doctor, if pregnant or breastfeeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical anesthetic
Indications And Usage
Temporarily relieves minor pain.
Warnings
For external use only.
Do Not Use
■ More than one patch on your body at a time
■ On cut, irritated or swollen skin
■ On puncture wounds
■ For more than one week without consulting a doctor
■ If you are allergic to any active or inactive ingredients
■ If pouch is damaged or opened.
When Using This Product
■ Use only as directed
■ Read and follow all directions and warnings on this carton
■ Do not allow contact with the eyes
■ Do not use at the same time as other topical analgesics
■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use
■ Do not microwave
■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Stop Use And Consult A Doctor
■ Redness is present
■ Irritation develops
■ Symptoms persist for more than 7 days or clear up and occur again within a few days
■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.
If Pregnant Or Breastfeeding,
ask a health professional before use
Keep Out Of Reach Of Children And Pets.
If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.
Directions
Directions Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not more than use one patch in a 12 hour period. Maximum 2 patches per day. Discard patch after single use. Children under 12 years of age: consult a physician.
Other Information
Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.
Inactive Ingredients
aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water
Questions Or Comments
Call 1-866-326-1313
This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Aspercreme®.
Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
Distributed By:
Cardinal Health
Dublin, OH 43017
Made in China
Questions or comments?
Call 1-800-616-2471
www.majorpharmaceuticals.com
Principal Display Panel
LIDOCAINE PATCH 4%
MAXIMUM OTC STRENGTH
5 PATCHES
4% Bag Label (975031df D46d 4098 B1c0 1c0c92b41995 00)
* Please review the disclaimer below.
