Otc - Active Ingredient
ACTIVE INGREDIENT
Lidocaine 4% (w/w)
PURPOSE External analgesic
Numbing Cream
FDA Label NDC 87267-020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yiyangyuan Life Sciences (hong Kong) Co., Limited for the product Numbing (NDC 87267-020). 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, warnings, inactive ingredient, 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
USE
Temporarily relieves pain and itching due to: minor burns,sunburn, insect bites, scrapes, minor skin irritations.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDRENIf swallowed, get medical help or contact a Poison ControlCenter right away.
Dosage & Administration
Cleanse targeted skin area, pat dry. · Apply a thin layer tothe affected area, not more than 3-4 times daily.
Indications & Usage
Condition worsens or does not improve within 7 days.·Allergic reaction occurs to ingredients in this product.Symptom being treated does not subside or if redness,irritation.
Warnings
WARNINGSFor external use only.
Inactive Ingredient
INACTIVE INGREDIENTS
Water,Carbomer 934,Propylene Glycol,Arnica montana,SoybeanLecithin,Alpha-Tocopherol Acetate,Benzyl Alcohol.
Package Label.Principal Display Panel
Labeling (87267 020 01)
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