Label: PRINUMB TATTOO NUMBING CREAM- tattoo numbing cream cream

  • NDC Code(s): 84555-002-01, 84555-002-02, 84555-002-03, 84555-002-04, view more
    84555-002-05, 84555-002-06
  • Packager: Shijiazhuang Auro Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2024

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  • Active Ingredient

    Lidocaine 4%

  • Purpose

    Local Anesthetic

  • Use

    For temporarily relieves pain and itching associated with minor burns, minor cuts or skin irritations

  • Warnings

    For External Use Only

  • Do not use

    Pregnant or breastfeeding, ask your doctor before use.
    in case of accidental overdose, seek immediate medical help or contact the Poison Control Center.
    seal is broken or missing.

  • When Using

    Do not exceed the recommended daily dosage unless directed by a doctor.
    Certain persons can develop allergic reactions to ingredients in this product.
    Do not put this product into the rectum by using fingers or any medical device or applicator.

  • Stop Use

    The symptom being treated does not improve, or if redness, irritation, swelling, pain, or other symptoms appear or worsen. Seek medical help right away.

  • Ask Doctor

    discomfort persists for 7 days.

  • Keep Oot Of Reach Of Children

    Avoid contact with the eyes.If swallowed,seek medical attention immediately.

  • Directions

    Apply up to 3 times a day.
    Children (under 12 years of age): consult a doctor.
    Adults: before applying this product, clean the affected area with mild soap and warm water and rinse thoroughly. Pat dry the area with a soft cloth or tissue.

  • Other information

    Store at room temperature and out of direct sunlight or heat.

  • Inactive ingredients

    .Alpha.-Tocopherol Acetate
    Carbomer 940
    Chrysanthemum Extract
    Glycerol，
    Lecithin, Soybean
    Portulaca Oleracea Extract
    Prilocaine
    Propylene Glycol
    Sodium Hyaluronate
    Water

  • PRINCIPAL DISPLAY PANEL

    1234

  • INGREDIENTS AND APPEARANCE
    PRINUMB TATTOO NUMBING CREAM 
    tattoo numbing cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84555-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CHRYSANTHEMUM INDICUM WHOLE (UNII: O9ECF2PL1F)  
    PRILOCAINE (UNII: 046O35D44R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    PURSLANE (UNII: M6S840WXG5)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84555-002-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/2024
    2NDC:84555-002-02100 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package07/17/2024
    3NDC:84555-002-03150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/2024
    4NDC:84555-002-04200 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/2024
    5NDC:84555-002-0530 mL in 1 TUBE; Type 0: Not a Combination Product07/17/2024
    6NDC:84555-002-0660 mL in 1 TUBE; Type 0: Not a Combination Product07/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/17/2024
    Labeler - Shijiazhuang Auro Technology Co., Ltd. (406846461)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shijiazhuang Auro Technology Co., Ltd.406846461manufacture(84555-002)
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