FDA.reportPublic FDA data

TKTX NUMB

Manufacturer
USA MINGER Inc.
Effective date
2025-03-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:40:20

Label at a glance#

ProductTKTX NUMB
Active ingredientPROCAINE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Procaine 5%

OTC - PURPOSE SECTION

Topical anesthetic

INDICATIONS & USAGE SECTION

Tattoo, waxing and hair removal etc.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

on open skin wounds. in ornear the eyes. in case of contact, rinse eyes thoroughlywith water and stop using.

OTC - WHEN USING SECTION

keep out of eyes, ears, andmouth. Incase of contact witheyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

and ask a doctor if irritationor rash occurs. These may be signs of allergy.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medicalhelp or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

labellabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84353-004TKTX NUMB (PROCAINE) OINTMENT [USA MINGER INC.]1Unmatched20250322_30acbc73-7b90-2de2-e063-6394a90a242e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84353-00484353-004-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PURSLANEM6S840WXG5IACT
CHRYSANTHELLUM INDICUM TOPSTJ856D1Z0IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
GLYCERINPDC6A3C0OXIACT
PROCAINE4Z8Y51M438ACTIB
CARBOMER0A5MM307FCIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
EDETATE DISODIUM7FLD91C86KIACT
MENTHA ARVENSIS LEAFA4IWO4DDZ9IACT
PEG-40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
523a46cd-03fa-d70b-e063-6294a90acb9730acbc73-7b90-2de2-e063-6394a90a242e2025-04-01WarningsExact identifier
spl set id: 30acbc73-7b90-2de2-e063-6394a90a242e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.