Otc - Active Ingredient
Lidocaine 4% (w/w)
Assielf Numbing Topical Anorectal Cream
FDA Label NDC 87418-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Yuanbang International Logistics Co., Ltd for the product Assielf Numbing Topical Anorectal (NDC 87418-001). 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
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 CHILDREN
If swallowed, get medical help or contact a poison control
center right away.
Dosage & Administration
DIRECTIONS
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.
Inactive Ingredient
Water,Carbomer 934,Propylene Glycol,Soybean Lecithin, AlphTocopherol Acetate,Benzyl Alcohol.
Warnings
DO NOT USE
on large areas of the body. on broken, blistered, orabraded skin. if allergic to local anesthetics such aslidocaine, benzocaine, or other"caine" derivatives.WHEN USINGavoid contact with the eyes- do not bandage tightly or usewith heating pad - use only as directed
Package Label.Principal Display Panel
Labeling (87418 001 01)
* Please review the disclaimer below.
