Label: XESSO NEO- benzocaine spray

  • NDC Code(s): 81777-106-04
  • Packager: PREMIUM NATURAL COSMETICS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 16, 2024

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

  • Warning Section

    Warning

    • METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of

    breath, dizziness or lightheadedness, fatigue, or lack of energy.

    • Sore Throat Warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. For adult use only.
    • Keep this and all drugs out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away.
    • As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.
    • Stop use and consult a doctor if difficulty in breathing occurs, swelling or fever develops, or if sore mouth or throat symptoms do not improve within 7 days.
    • Do not exceed the recommended dosage.
    • Keep away from fire or flames.

    Keep out of reach of children section

    Keep this and all drugs out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away.

  • Directions

    Apply to the affected area (one spray).
    Allow to remain in place for at least 15 seconds then spit out.
    May be repeated every two hours as needed or as directed by a health care professional.

  • Inactive Ingredients

    Alcohol, FD&C RED NO. 40, Glycerinm, Natural Flavors, PEG-40 Hydrogenated Castor Oil, Polyvinylpryyolidone (PVP), Sucralose), Water

  • Use Section

    For temporary relief of minor throat irritation, pain, and sore throat.

  • Active Ingredient

    Benzocaine 5%

  • Purpose

    Oral Anesthetic

  • Other Information

    Tamper-Evident: Do not use if tamper evident seal on the outside of the container is broken or missing.
    Store at room temperature 20 - 25 C (68 - 77 F)

  • PDP and Back Panel

    PDP

  • INGREDIENTS AND APPEARANCE
    XESSO NEO 
    benzocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81777-106
    Route of AdministrationTOPICAL, ORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) 0.1 g  in 100 mL
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) 2 g  in 100 mL
    SUCRALOSE (UNII: 96K6UQ3ZD4) 1 g  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 33 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 18 g  in 100 mL
    ALCOHOL 95% (UNII: 7528N5H79B) 40 g  in 100 mL
    FD&C RED NO. 40 (UNII: WZB9127XOA) 0.0006 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81777-106-0459 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/16/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/16/2024
    Labeler - PREMIUM NATURAL COSMETICS INC (051403646)
    Registrant - Creative Essences Inc (079120182)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creative Essences Inc079120182manufacture(81777-106)