FDA.reportPublic FDA data

TKTX NUMB

Manufacturer
USA MINGER Inc.
Effective date
2025-02-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:40:58

Label at a glance#

ProductTKTX NUMB
Active ingredientTETRACAINE, PROCAINE, PRILOCAINE
Label structure12 sections

Storage and handling

No data available

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

PROCAINE 5%
TETRACAINE 1%
PRILOCAINE 1%

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 or near the eyes. In case of contact, rinse eyes
thoroughly with water and stop using.

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes
thoroughly with water.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison C ontrol Center right
away.

DOSAGE & ADMINISTRATION SECTION

After cleaning the skin [warm water is better), apply appropriate amount of
tattoo cream to the area to be tattooed, cover the plastic wrap,
Wait 50 mins to 60 mins for the numbing cream to take effect,
then get tattooed.
All Submissions Drug Listing and Certification Products Content of Labeling

STORAGE AND HANDLING SECTION

No data available

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
84353-002TKTX NUMB (PROCAINE, TETRACAINE, PRILOCAINE) CREAM [USA MINGER INC.]1Unmatched20250228_2f1c3a39-8d7f-28ad-e063-6394a90aa566.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84353-00284353-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
TETRACAINE0619F35CGVACTIB
PROCAINE4Z8Y51M438ACTIB
CARBOMER0A5MM307FCIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
WATER059QF0KO0RIACT
PRILOCAINE046O35D44RACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM7FLD91C86KIACT

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
523ab6f8-6986-f2de-e063-6394a90a512d2f1c3a39-8d7f-28ad-e063-6394a90aa5662025-02-28WarningsExact identifier
spl set id: 2f1c3a39-8d7f-28ad-e063-6394a90aa566

Reported adverse events (FAERS/openFDA)#

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