Otc - Active Ingredient
Procaine 5%
Tktx Numb
FDA Label NDC 84353-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Usa Minger Inc. for the product Tktx Numb (NDC 84353-004). 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 - when using, otc - stop use, 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
Topical anesthetic
Indications & Usage
Tattoo, waxing and hair removal etc.
Warnings
For external use only.
Otc - Do Not Use
on open skin wounds. in ornear the eyes. in case of contact, rinse eyes thoroughlywith water and stop using.
Otc - When Using
keep out of eyes, ears, andmouth. Incase of contact witheyes, rinse eyes thoroughly with water.
Otc - Stop Use
and ask a doctor if irritationor rash occurs. These may be signs of allergy.
Otc - Keep Out Of Reach Of Children
If swallowed, get medicalhelp or contact a Poison Control Center right away.
Dosage & Administration
1. Wnscrew the cap and tear off the seal before using, Tighten the cap in time after use.
2. Wash the skin with soap and warm water making sure it's clean and free of bacteria.
3. Put the cream evenly on the skin (1 mm thick), and cover it with a plastic wrap for 50-60 minsto achieve 4-6 hours of numbness.
4. Before starting the operation, remove the cream and let the skin breathe for 5-10 mins. Whenapplving this cream, Please keep the skin warm for faster absorption.
Inactive Ingredient
WATER
PROPYLENE GLYCOL
CARBOMER
GLYCERIN
DISODIUM EDTA
HYDROXYACETOPHENONE
1,2-HEXANEDIOL
MENTHA ARVENSIS LEAF EXTRACT
CHRYSANTHELLUM INDICUM EXTRACT
PORTULACA OLERACEA EXTRACT
PEG-40 HYDROGENATED CASTOR
Package Label.Principal Display Panel
Label (Label)
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