Label: JUANCHI TATTOO NUMBING- lidocaine cream

  • NDC Code(s): 83603-001-03
  • Packager: Shenzhen Langmi Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated August 6, 2023

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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.

  • WHEN USING

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

  • 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.

  • 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

  • INGREDIENTS AND APPEARANCE
    JUANCHI TATTOO NUMBING 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83603-001
    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:83603-001-031 in 1 PACKAGE08/07/2023
    160 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(83603-001)
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