FDA Label for Dermfree Tattoo Numbing
View Indications, Usage & Precautions
Dermfree Tattoo Numbing Product Label
The following document was submitted to the FDA by the labeler of this product Jiangxi Hemei Pharmaceutical Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Lidocaine 4%
Purpose
Local 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
■In children less than 2 months of age on open skin wounds,
■Do not exceed the recommended daily dosage unless directed by a doctor
When Using
■Avoid contact with eyes, lf this happens, rinse thoroughly with water.
Stop Use
■If symptoms persist for more than 7 days or subside but occur again within 3 days, stop use and consult a physician.
■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.
Ask Doctor
■If symptoms persist for more than 7 days or subside but occur again within 3 days, stop use and consult a physician.
■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.
Keep Out Of Reach Of Children
Keep out of reach of children
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 in thoroughly in a circlar motion for 30 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.
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.
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