Kaisasa Tattoo Numbing
FDA Label NDC 83603-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Langmi Technology Co., Ltd. for the product Kaisasa Tattoo Numbing (NDC 83603-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)

Lidocaine 5%

Purpose

For temporary relief of local discomfort, itching,pain, soreness or burning related to the tattooprocess.

Use

For temporary relief of local discomfort, itching, pain,soreness or burning related to the tattoo process.

Warnings

For external use only.

Do Not Use

Do not exceed the recommended daily dosage unless directed by a doctor.

Otc - When Using

Avoid contact with eyes. If this happens, rinse thoroughly with water.

Otc - Stop Use

lf symptoms persist for more than 7 days or subside but occur again within 3 days, stop use and consult a physician.
Stop use and get to a doctor if allergy occurs such as redness, irritation, swelling, pain or other symptoms become severe or does not subside completely within 7 days.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. 

Directions

1. Clean the specific area, thendry.
2.Apply cream to the area to betattooed with a thick coat (near 2mm) . Wrap the applied area tightly with plasticwrap and waitfor 45~65 minutes.
3.Tear off the plastic wrap, wipeoff cream, wait for 25 minutesmore to start your tattoo work.

Storage And Handling

  • Store between 15-30℃(59-86F).Avoid freezing and excessive heat above 40℃(104F).

Inactive Ingredients

WATER,PROPYLENE GLYCOL,GLYCERIN,CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE,EDETATE DISODIUM ANHYDROUS,
HYDROXYACETOPHENONE,1,2-HEXANEDIOL,Tocopherol,MENTHAARVENSIS LEAF,CHRYSANTHELLUM INDICUM TOP, PURSLANE,POLYOXYL40 HYDROGENATED CASTOR OIL

Package Label - Principal Display Panel

Image Description (Kaisasa60g)

Image Description (Kaisasa60g)

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