KAISASA TATTOO NUMBING- lidocaine cream 
Shenzhen Langmi Technology Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

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

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.

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

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

KAISASA TATTOO NUMBING 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83603-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
TOCOPHEROL (UNII: R0ZB2556P8)  
MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)  
CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)  
PURSLANE (UNII: M6S840WXG5)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83603-002-021 in 1 PACKAGE08/07/2023
150 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01708/07/2023
Labeler - Shenzhen Langmi Technology Co., Ltd. (636993410)
Establishment
NameAddressID/FEIBusiness Operations
Shenzhen Langmi Technology Co., Ltd.636993410manufacture(83603-002)

Revised: 8/2023
Document Id: 024d79ae-b2fd-29e7-e063-6294a90ad00b
Set id: 6caec60b-8faf-4238-8e66-4f2569436517
Version: 1
Effective Time: 20230806
 
Shenzhen Langmi Technology Co., Ltd.