Label: PAINLESS TATTOO 1- benzocaine cream

  • NDC Code(s): 54723-015-01
  • Packager: Sambria Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 9, 2024

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  • Drug Facts

  • Active ingredient

    Benzocaine 20%

  • Purpose

    External Analgesic

  • Uses

    For temporary relief of pain and itching.

  • Warnings

    For external use only.

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

    When using this productuse only as directed. Avoid contact with the eyes, rashes, or mucous membranes.

    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 children and petsIf swallowed get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    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

    Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    PAINLESS TATTOO 1 
    benzocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    EMU OIL (UNII: 344821WD61)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    LAURETH-7 (UNII: Z95S6G8201)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54723-015-013 mL in 1 PACKET; Type 0: Not a Combination Product09/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/26/2023
    Labeler - Sambria Pharmaceuticals, LLC (078676259)
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