Label: OHEAL TATTOO NUMBING CREAM- tattoo numbing cream cream

  • NDC Code(s): 83176-012-01
  • Packager: Dr.luke Healthcare LLC
  • 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 June 30, 2023

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  • Active Ingredient

    Lidocaine 4%

  • Purpose

    External Analgesic

  • Use

    For temporary relief of local and anorectal discomfort associated with anorectal discomfort or inflammation

  • Warnings

    For External Use Only
    Pregnant or breastfeeding, ask a health professional before use.
    In case of accidental overdose, contact a doctor or Poison Control Center immediately.
    Seal is broken or missing.

  • Do not use

    Pregnant or breastfeeding, ask a health professional before use.
    In case of accidental overdose, contact a doctor or Poison Control Center immediately.
    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 subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

  • Ask Doctor

    The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

  • Keep Oot Of Reach Of Children

    In case of accidental ingestion, seek medical attention immediately.

  • Directions

    Perform a patch test on the back of your hand before using it to check for skin sensitivity.When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
    Apply up to 2 times a day.（Children under 12 years of age: consult a doctor.)

  • Other information

    Keep away from direct sunlight or heat
    Store in room temperature (59-860F / 15-300C)

  • Inactive ingredients

    Glycerin, Butylene Glycol, Xanthan Gum, Sodium Hyaluronate, Butyrospermum Parkii (Shea Butter) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Dimethicone, Glyceryl Stearate, Cetearyl Glucoside, Cetearyl Alcohol, Tocopherol, Menthol, Borneol

  • Questions

    www.ohealpro.com

    Info@ohealpro.com
    669-588-4076

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    OHEAL TATTOO NUMBING CREAM 
    tattoo numbing cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83176-012
    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
    SHEA BUTTER (UNII: K49155WL9Y)  
    SQUALANE (UNII: GW89575KF9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    TETRACAINE (UNII: 0619F35CGV)  
    PROCAINE (UNII: 4Z8Y51M438)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BORNEOL (UNII: M89NIB437X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)  
    CENTELLA ASIATICA ROOT (UNII: 8MXU1P42J0)  
    PRILOCAINE (UNII: 046O35D44R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    RICE GERM (UNII: 7N2B70SFEZ)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83176-012-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01606/29/2023
    Labeler - Dr.luke Healthcare LLC (118868014)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr.luke Healthcare LLC118868014label(83176-012) , manufacture(83176-012)
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