Otc - Active Ingredient
Salicylic Acid 10%
Chlorhexidine Diacetate 2%
Genital Warts Remover Cream
FDA Label NDC 87278-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangxi Keyun E-commerce Co., Ltd. for the product Genital Warts Remover Cream (NDC 87278-004). 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, indications & usage, warnings, otc - do not use, otc - stop use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Wart Remover
Indications & Usage
1.After washing the fecled area with warm water,take an apropriate amount of this product with a toothpick and apply it to the surface of the aflected area. Gently knead for 5-10 minutes to make it fully absorbed. Please do not to apply it fo the surrounding healthy skin andmucous membranes.
2.2-3 times a day, Use it continǔcusly fór 7 days.
If it does not fall off,it is recommended to continue to use it.
Scope of Application : Suitable for alleviating pain and discomfort caused by skin warts.
Warnings
1.External supplies, do not let it into the mouth and eye.
2.Use with caution for those of skin allergy and pregnant.
3.Place the product in a place where chil¤fen aré nöt easy to contact
4.This product is not a substitute for drugs.
Otc - Do Not Use
Do not use ifthe skin is hurt.Contrain dicated for pregnant women.
Otc - Stop Use
Discontinue use if signs ofirritation orrash occur
Otc - When Using
1. Avoid direct contact with the eyeslf product comes intocontact with eyes, rinse thoroughly.
2.if there isany discomfort or irritation, afterapplication,immediately discontinue use.
3. Not suitable for children orwomen who are pregnant orbreast feeding.
Otc - Keep Out Of Reach Of Children
Please keep out of reach ofchildren.
Dosage & Administration
1.After washing the fecled area with warm water,take an apropriate amount of this product with a toothpick and apply it to the surface of the aflected area. Gently knead for 5-10 minutes to make it fully absorbed. Please do not to apply it fo the surrounding healthy skin andmucous membranes.
2.2-3 times a day, Use it continǔcusly fór 7 days.
If it does not fall off,it is recommended to continue to use it.
Scope of Application : Suitable for alleviating pain and discomfort caused by skin warts.
Inactive Ingredient
Java Brucea Fruit (Brucea javanica Fruit)
Patrinia Scabiosaefolia
Zanthoxylum Bungeanum
Stemona Root (Stemona japonica Root)
Kochia Scoparia
Cnidium Monnieri
Gentian (Gentiana scabra root)
Alum (Potassium Alum)
Benzoic Acid
Glycerin
Stearic Acid
Cetearyl Alcohol
Methylparaben
Ethyl Hydroxybenzoate (Ethylparaben)
Water
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Label (Label)
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