Label: FRANKLYNUMB 3- tetracaine cream

  • NDC Code(s): 54723-004-01
  • Packager: Sambria Pharmaceuticals, LLC
  • 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 December 8, 2021

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Tetracaine 2% 

  • Purpose

    External Analgesic

  • Uses

    For temporary relief of pain and itching due to minor skin irritations.

  • warnings

    For external use only.
    Avoid contact with eyes.

    Do not use in large quantities, particularly over the raw surfaces or blistered area 

    Stop use and ask a doctor if

    condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within the few days. Discontinue use.

  • Keep out of reach of children 

    If product is swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    For adults and children two-years or older: Apply to affected area not more than 3 or 4 times
    daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.

  • Inactive ingredients

    Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate,
    Emu Oil, Ethoxydiglycol, Ethylhexyglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7,
    Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol,Polyacrylamide, Propylene Glycol,StearicAcid,Triethanolamine.

  • Other information

    Protect this product from excessive heat and direct sun.

  • Questions or comments?

    support@franklynumb.com

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    FRANKLYNUMB 3 
    tetracaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV) TETRACAINE2 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 (10000 MW) (UNII: E2KR9C9V2I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54723-004-014 mL in 1 POUCH; Type 0: Not a Combination Product12/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/08/2021
    Labeler - Sambria Pharmaceuticals, LLC (078676259)