Active Ingredient
Lidocaine 4% (w/w)
Puvida Numbing Cream
FDA Label NDC 85248-173
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Puvida Numbing (NDC 85248-173). 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, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Use
For temporary relief of local discomfort, itching, pain, soreness, or burning associated with minor skin procedures.
Warnings
For external use only.
Do Not Use
·In children under 2 years of age or on irritated or sensitive skin
·Do not exceed the recommended daily dosage unless directed by a doctor.
·Avoid contact with eyes. If this happens, rinse thoroughly with water.
·If symptoms persist for more than 7 days or subside but occur again within 3 days, stop use and consult a physician.
When Using
·Avoid contact with eyes, lf this happens, rinse thoroughly with water.
Stop Use
Stop use and seek medical attention if signs of an allergy occur, such as redness, irritation, swelling, pain, or other severe symptoms. If symptoms do not subside completely within 7 days, seek medical help.
Ask Doctor
Stop use and seek medical attention if signs of an allergy occur, such as redness, irritation, swelling, pain, or other severe symptoms. If symptoms do not subside completely within 7 days, seek medical help.
Keep Oot Of Reach Of Children
Keep out of reach of children.
Directions
·Before applying the numbing cream, make sure to wash your hands thoroughly and put on disposable procedure gloves.
·Clean the area of the body receiving the procedure. Dry completely.
·Apply a generous amount of numbing cream to the cleaned area and rub it in thoroughly in a circular 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 the upcoming procedure.
Other Information
Store between 15‑30°C (59‑86°F). Avoid freezing and excessive heat above 40°C (104°F).
Inactive Ingredients
Water, Carbomer 934, Propylene Glycol, Soybean Lecithin, Alpha-Tocopherol Acetate, Benzyl Alcohol.
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