Label: AOBBIY TATTOO NUMBING CREAM- tattoo numbing cream cream

  • NDC Code(s): 82739-016-01, 82739-016-02, 82739-016-03, 82739-016-04, view more
    82739-016-05
  • Packager: Shenzhen Situya Trading Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 16, 2023

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  • Active Ingredient

    LIDOCAINE 4%

  • Purpose

    Local Anesthetic

  • Use

    temporarily relieves local and anorectal discomfort associated with the anorectal disorder or swelling.

  • 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 sensitive individuals may have an allergic reaction to some of the ingredients of this product.
    do not put this cream into the rectum using your fingers, applicators, or any medical devices.

  • 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.

  • Keep Oot Of Reach Of Children

    In case of accidental ingestion, seek medical help right away.

  • 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

    Keep away from direct sunlight or heat.
    Store at room temperature 59°-86°F (15°-30°C).

  • Inactive ingredients

    Aqua, Propylene Glycol, Carbomer 934, Lecithin (Soybean), Tocopheryl Acetate, Benzyl Alcohol.

  • Correct Use Steps Before Tattooing

    1. Clean your hands and the treatment area with soft soap and warm water, rinse thoroughly, then gently pat dry.
    2. Apply a thick layer of the numbing cream onto
    the treatment area.
    3. Wrap tightly with plastic wrap and wait 45-60 minutes for the numbness to peak. (The peak lasts up to 6 hours.) 4. Wipe away the residue with a soft cloth or tissue.
    5. Begin the procedure.

  • Notice

    Due to the difference in temperature and skin type, the numbness effect duration will differ. Testing in a small area first is recommended to ensure the best numbness effect.

  • PRINCIPAL DISPLAY PANEL

    010203

  • INGREDIENTS AND APPEARANCE
    AOBBIY TATTOO NUMBING CREAM 
    tattoo numbing cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82739-016
    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
    CARBOMER 934 (UNII: Z135WT9208)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82739-016-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2023
    2NDC:82739-016-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2023
    3NDC:82739-016-0375 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2023
    4NDC:82739-016-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2023
    5NDC:82739-016-05150 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/15/2023
    Labeler - Shenzhen Situya Trading Co., Ltd. (706154255)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Situya Trading Co., Ltd.706154255manufacture(82739-016) , label(82739-016)
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