Otc - Active Ingredient
Lidocaine:5%
Tattoo Numbing Cream
FDA Label NDC 85342-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Sanshisan Cosmetics Co., Ltd. for the product Tattoo Numbing (NDC 85342-002). 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, inactive ingredient, otc - purpose, warnings, otc - stop use, otc - do not use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Menthol
Chrysanthellum indicum extract
Portulaca oleracea extract
Vitamin E
Aloe Vera
Glycerin
Lecithin
Purified Water
Otc - Purpose
Local Anesthetic
Warnings
WARNING
For external use only.lf an allergic reaction occursdiscontinue use and consult adoctor.
lf pregnant or breastfeeding,consult a healthcare professionalbefore use.
Do not use if the seal is brokenor missing
Otc - Stop Use
Do not use if the seal is brokenor missing
Otc - Do Not Use
lf pregnant or breastfeeding,consult a healthcare professionalbefore use.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACHOF CHIDREN
If swallowed, go to the nearesthospital and seek immediatemedical help.
Indications & Usage
USESTemporarily relieves localdiscomfort, itching, pain, soreness,or burning on the skin surface.
Otc - When Using
WHEN USING THIS PRODUCTDo not exceed the recommended daily dosage unless directed bya doctor.
In case of accidental ingestionor overdose, seek medical helpimmediately or contact a PoisonControl Center.
Dosage & Administration
to an appropriate extent for product
Package Label.Principal Display Panel
85342-002-01labeling (Labeling 85342 002 01)
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