Tktx Numb

Tktx Numb
SPL v1
SPL
SPL Set ID 30acbc73-7b90-2de2-e063-6394a90a242e
Route
TOPICAL
Published
Effective Date 2025-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Procaine (5 g)
Inactive Ingredients
Water Purslane Chrysanthellum Indicum Top Hydroxyacetophenone Glycerin Carbomer Propylene Glycol 1,2-hexanediol Edetate Disodium Mentha Arvensis Leaf Peg-40 Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-19

Description

Procaine 5%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Tattoo, waxing and hair removal etc.

Dosage and 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.

Description

Procaine 5%

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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

Section 50570-1

on open skin wounds. in ornear the eyes. in case of contact, rinse eyes thoroughlywith 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%


Structured Label Content

Indications and Usage (34067-9)

Tattoo, waxing and hair removal etc.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

on open skin wounds. in ornear the eyes. in case of contact, rinse eyes thoroughlywith 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%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)