Tktx Numb

Drug Facts

Composition & Product

Active Ingredients

Tetracaine (1 g) Procaine (5 g) Prilocaine

Inactive Ingredients

Carbomer Hydroxyacetophenone Water Propylene Glycol Glycerin Edetate Disodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-02-27

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Tattoo, waxing and hair removal etc.

Dosage and Administration

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

Description

PROCAINE 5% TETRACAINE 1% PRILOCAINE 1%

Section 44425-7

No data available

Section 50565-1

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

away.

Section 50566-9

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

Section 50567-7

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

thoroughly with water.

Section 50570-1

on open skin wounds. in or near the eyes. In case of contact, rinse eyes

thoroughly with water and stop using.

Section 51727-6

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.

Section 51945-4

Section 55105-1

Topical anesthetic

Section 55106-9

PROCAINE 5%

TETRACAINE 1%

PRILOCAINE 1%

Structured Label Content

Indications and Usage (34067-9)

Tattoo, waxing and hair removal etc.

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)

No data available

Section 50565-1 (50565-1)

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

away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

thoroughly with water.

Section 50570-1 (50570-1)

on open skin wounds. in or near the eyes. In case of contact, rinse eyes

thoroughly with water and stop using.

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical anesthetic

Section 55106-9 (55106-9)

PROCAINE 5%

TETRACAINE 1%

PRILOCAINE 1%

Advanced Ingredient Data

[{"name": "TETRACAINE", "unii": "0619F35CGV", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PROCAINE", "unii": "4Z8Y51M438", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CARBOMER", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYACETOPHENONE", "unii": "G1L3HT4CMH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PRILOCAINE", "unii": "046O35D44R", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Tattoo, waxing and hair removal etc.", "34068-7": "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", "34071-1": "For external use only.", "44425-7": "No data available", "50565-1": "If swallowed, get medical help or contact a Poison C ontrol Center right away.", "50566-9": "and ask a doctor if irritation or rash occurs. These may be signs of allergy.", "50567-7": "keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "50570-1": "on open skin wounds. in or near the eyes. In case of contact, rinse eyes thoroughly with water and stop using.", "51727-6": "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.", "55105-1": "Topical anesthetic", "55106-9": "PROCAINE 5% TETRACAINE 1% PRILOCAINE 1%"}