Active Ingredient
Lidocaine 5%
Lidocaine 5% Cream
FDA Label NDC 84007-335
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medhome Pharma Inc for the product Lidocaine 5% (NDC 84007-335). 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, use, warnings, do not use, stop use, ask doctor, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical anesthetic
Use
For temporary relief of local discomfort, itching, pain, soreness, or burning related to the tattoo process
Warnings
For external use only.
Do Not Use
Do not exceed the recommended daily dosage unless directed by a doctor
Stop Use
Do not exceed the recommended daily dosage unless directed by a doctor.
Avoid contact with eyes. lf this happens, rinse thoroughly with water.
lf symptoms persist for more than 7 days or subside but occur again within 3 days, stop use and consult a physician.
Stop use and seek medical attention if signs of an allergy occur, such as redness,iritation, sweling, pain, or other severe symptoms. fsymptoms do not subside completely within 7 days, seek medica help.
Ask Doctor
Stop use and sek meditcal attention if signs of an alerqy occur,such as rednes,irtation,sweling, pain, or other severe symptoms.If symptoms do not subside completely within 7 days, seek medical help.
Directions
Before applying the numbing cream, thoroughly wash your hands and wear disposable tattoo gloves.
Clean the area of the body receivina the tattoo,Dry completely.
Apply a generous amount of numbing cream to the cleaned area and rub it inthoroughly in a circlar motion for30 to 60 seconds,Then. cover with plastic wrap.
Leave the cream and wrap in place for 30 to 45 minutes,Wipe away the cream and thoroughly clean the area to prepare for a pain-free tattoo.
Keep Out Of Reach Of Children
Keep out of reach of children
Other Information
Store between 15-30℃(59-86F). Avoid freezing and excessive heat above 40 ℃(104°F).
Inactive Ingredients
Water,Carbomer934, propylene Glycol,soybean Lecithin,.Alpha.-Tocopherol Acetate,Benzyl Alcohol.
Package Label.Principal Display Panel
1 (Cream)
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