Warnings
For external use only
Signature Numbing Cream
FDA Label NDC 84019-034
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shengnan (guangzhou) Cosmetics Co., Ltd for the product Signature Numbing Cream (NDC 84019-034). 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 warnings, otc - purpose, otc - stop use, otc - active ingredient, otc - when using, inactive ingredient, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Temporary relief of pain, itching, soreness, or burning in the perianal area from anorectal disorders.
Otc - Stop Use
Allergic reaction or rectal bleeding occurs.Redness,irritation, swelling, or pain increases.Condition worsens or lasts >7 days
Otc - Active Ingredient
5% Lidocaine
Otc - When Using
Wash the area with soap and water
Inactive Ingredient
Benzyl Alcohol, Carbomer 934, Lecithin (Soybean), Mentha Arvensis Leaf Extract, Chrysanthemum Indicum
Extract, Portulaca Oleracea Extract, Propylene Glycol, Tocopheryl Acetate, Water
Dosage & Administration
Apply 1-3 times a week
Indications & Usage
Adults and children 12 years and older: When practical, cleanse the affected area with mild soap andwarm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft clothbefore application of this product.Apply to the affected area up to 6 times daily.Children under 12 years: Consult a doctor.
Package Label.Principal Display Panel
1 (543a9392eb752b9612c244a563a8ccf)
* Please review the disclaimer below.
