Label: PAINLESS TATTOO NUMBING- lidocaine hydrochloride liquid

  • NDC Code(s): 54723-019-01
  • Packager: Sambria Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 14, 2024

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  • Drug Facts

  • Active ingredient

    Lidocaine HCL 4.0% 

  • Purpose

    External Analgesic

  • Uses

    For temporary relief of pain and itching.

  • Warnings

    For external use only.

    Flammable: Do not use near heat, flame, or while smoking.

    Do not useon wounds or damaged skin, in large quantities, or if you are allergic to any ingredients of this product.

    When using this productuse only as directed. Keep away from face to avoid breathing it. Avoid contact with eyes. Do not store at temperatures above 120°F. Do not puncture or incinerate.

    Stop use and ask doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    Keep out of reach of childrenand pets If swallowed get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Shake well. Do not spray on face. Adults and children 12 years of age and over: Clean and dry affected area, apply to affected area not more than 3 to 4 times daily. Children 12 years of age or younger: ask a doctor.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Aqua (Deionized Water), Dimethyl Sulfone, Disodium EDTA, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Propylene Glycol, SD Alcohol 40-B

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    PAINLESS TATTOO NUMBING 
    lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54723-019-0141 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/09/2024
    Labeler - Sambria Pharmaceuticals, LLC (078676259)
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