Label: NUPHARMISTO TATTOO NUMBING CREAM- tattoo numbing cream cream

  • 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 February 15, 2023

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  • Active Ingredient(s)

    Lidocaine 5%

  • Purpose

    Local Anesthetic

  • Use

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

  • Warnings

    For external use only

  • Do not use

    Pregnant or breastfeeding, ask a health professional before use.
    In case of accidental overdose, get medical help or contact the
    Poison Control Center immediately.
    Seal is broken or missing

  • WHEN USING

    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 finger or
    any medical device or applicator

  • STOP USE

    the symptom being treated does not subside, or if redness

  • KEEP OUT OF REACH OF CHILDREN

    Adults: When practical, cleanse the affected area with mild soap
    and warm water and rise thoroughly.
    Gently dry by patting with toilet tissue or a soft cloth, before
    application of this product.
    Apply up to 6 times a day.
    Children under 12 years of age: consult a doctor

  • Directions

    Adults: When practical, cleanse the affected area with mild soap
    and warm water and rise thoroughly.
    Gently dry by patting with toilet tissue or a soft cloth, before
    application of this product.
    Apply up to 6 times a day.
    Children under 12 years of age: consult a doctor

  • Other information

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

  • Inactive ingredients

    Carbomer 934, Emu Oil, Arnica, Lecithin(Soybean), Propylene
    Glycol, Tocopheryl Acetate, Benzyl Alcohol, Water

  • ASK DOCTOR

    irritation, swelling, pain, or other symptoms develop or increase

  • QUESTIONS

    service@nupharco.com

  • Package Label - Principal Display Panel

    81799-008-01 1

    81799-008-01 1

    81799-008-01 2

    81799-008-01 2

  • INGREDIENTS AND APPEARANCE
    NUPHARMISTO TATTOO NUMBING CREAM 
    tattoo numbing cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81799-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81799-008-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34802/15/2023
    Labeler - Ehy Holdings LLC (117322715)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ehy Holdings LLC117322715manufacture(81799-008)
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