Otc - Active Ingredient
LIDOCAINE 4%
Vbbv Numbing Cream
FDA Label NDC 84867-015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiashen International Trade Limited for the product Vbbv Numbing (NDC 84867-015). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, dosage & administration, indications & usage, inactive ingredient, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
For the temporary relief of local and anorectal itching and discomfortassociated with anorectal disorders.
Otc - Keep Out Of Reach Of Children
Children under 12 years of age: Consult a physician. keep out of reach of children
Dosage & Administration
Adults:1. When practical, cleanse the affected area with mild soap and warmwater and rinse thoroughly. Gently dry it by patting or blotting it withtoilet tissue or a soft cloth before applying this product.
2. Apply a thin layer to the affected area every 6 to 8 hours, not toexceed 3 applications in a 24-hour period.
Indications & Usage
Directions:
Children under 12 years of age: Consult a physician.
Inactive Ingredient
Inactive ingredientS:TETRACAINE PRILOCAINE AQUA PROPYLENEGLYCOL CARBOMER GLYCERIN DISODIUM EDTA HYDROXYACETOPHENONE1,2-HEXANEDIOL MENTHA ARVENSIS LEAF EXTRACT CHRYSANTHELLUMINDICUM EXTRACT PORTULACA OLERACEA EXTRACT PEG-40HYDROGENATED CASTOR OIL
Warnings
Warnings:For external use onlyAvoid contact with the eyes.Do not use in large quantities, particularly over raw surfaces or blistered areas anddo not exceed the recommended daily dosage unless directed by a doctor.
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ASK DOCTOR
Ask a doctor before use if you havelf pregnant or breast-feeding, ask a health professional before use.
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STOP USE
Stop use and ask a doctor if
lf symptoms of redness or allergy occur, discontinue use, and consult a physician.
Package Label.Principal Display Panel
Labeling (84867 015 01)
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