FDA.reportPublic FDA data

TXTK NUMB

Manufacturer
USA MINGER Inc.
Effective date
2025-03-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:40:30

Label at a glance#

ProductTXTK 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 ofcontact, rinse eyes thoroughlywith water and stop using.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

1. Unscrew 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. Whenapplying this cream, Please keep the skin warm for faster absorption.

INACTIVE INGREDIENT SECTION

AQUA
1,2-HEXANEDIOL
PROPYLENE GLYCOL
MENTHA ARVENSIS LEAF EXTRACT
CARBOMER
CHRYSANTHELLUM INDICUM EXTRACT
GLYCERIN
PORTULACA OLERACEA EXTRACT
DISODIUM EDTA
PEG-40 HYDROGENATED CASTOR
HYDROXYACETOPHENONE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84353-003TXTK NUMB (PROCAINE) OINTMENT [USA MINGER INC.]1Unmatched20250316_30481789-9d61-325b-e063-6394a90a9674.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
84353-00384353-003-01

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
PROPYLENE GLYCOL6DC9Q167V3IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
AQUA059QF0KO0RIACT
MENTHA ARVENSIS LEAFA4IWO4DDZ9IACT
CARBOMER0A5MM307FCIACT
CHRYSANTHELLUM INDICUM TOPSTJ856D1Z0IACT
GLYCERINPDC6A3C0OXIACT
PURSLANEM6S840WXG5IACT
EDETATE DISODIUM7FLD91C86KIACT
PEG-40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
PROCAINE4Z8Y51M438ACTIB

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
523a9baf-3149-c86c-e063-6394a90a871930481789-9d61-325b-e063-6394a90a96742025-04-01WarningsExact identifier
spl set id: 30481789-9d61-325b-e063-6394a90a9674

Reported adverse events (FAERS/openFDA)#

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