Label: COMFORTOX TETRACAINE- tetracaine hcl cream

  • NDC Code(s): 54723-997-01
  • Packager: Sambria Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 January 14, 2022

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  • ​Active Ingredients

    Tetracaine HCL     2.0% w/w

  • ​Purpose

    External Analgesic

  • ​Uses

    For temporary relief of pain and itching due to minor skin irritation

  • WARNINGS

    ​For external use only

    Avoid contact with eyes

  • DO NOT USE

    ​Do not use​ in large quantities, particularly over raw surfaces or blistered areas

  • STOP USE

    ​Stop use and ask a doctor if

    • Condition worsens, or if symptoms persist for more then 7 days or clear up and occur again within a few days.  Discontinue use.

  • KEEP OUT OF REACH OF CHILDREN

    ​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 to 4 times daily.  Children under 2 years of age: consult a physician.

  • ​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

  • ​Other Information

    Protect this product from excessive heat and direct sun.

  • ​Questions or Comments?

    FDA Registered: NDC No. 54723-997-01

    800-693-9067

  • PRINCIPAL DISPLAY PANEL

    packet

  • INGREDIENTS AND APPEARANCE
    COMFORTOX TETRACAINE 
    tetracaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-997
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV) TETRACAINE HYDROCHLORIDE20 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CHONDROITIN SULFATE SODIUM (BOVINE) (UNII: 8QTV3DTT8W)  
    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)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54723-997-011500 mg in 1 PACKET; Type 0: Not a Combination Product09/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/14/2016
    Labeler - Sambria Pharmaceuticals, Inc. (078676259)
    Establishment
    NameAddressID/FEIBusiness Operations
    A.I.G. Technologies, Inc.086365223manufacture(54723-997)
    Establishment
    NameAddressID/FEIBusiness Operations
    JP Packaging LLC151369456repack(54723-997)