Warnings
For external use only.
Dr Wellskin Numbing Cream
FDA Label NDC 84019-042
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 Dr Wellskin Numbing Cream (NDC 84019-042). 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
Topical Anesthetic
Otc - Stop Use
Allergic reaction occurs.
Rectal bleeding occurs.
Condition worsens or does not improve within 7 days.
Redness, irritation, sweling, pain, or other symptoms begin or increase.
Otc - Active Ingredient
4% Lidocaine
Otc - When Using
Do not exceed the recommended daily dosage unless directed by adoctor
Do not insert into the rectum using fingers or any mechanical device orapplicator
Inactive Ingredient
Water, Propylene Glycol, Glycerin, Carbomer, Disodium EDTA, Hydroxyacetophenone, 1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Mentha Arvensis Leaf Extract, Chrysanthellum Indicum Extract, Portulaca Oleracea Extract,Tocopheryl Acetate.
Dosage & Administration
Adults and children 12
years and older: Apply a
thin layer to the affected
area 1-3 times daily or
as directed by a
healthcare provider.
Indications & Usage
Adults and children 12 years and older: When practical, cleanse theaffected area with mild soap and warm water and rinse thoroughly.Gently dry by patting or blotting with toilet tissue or a soft cloth before application.
Apply a thin layer of cream to the affected area up to 6 times daily as needed.
Children under 12 years: Consult a doctor.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right
away.
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