Label: ULCEREASE- phenol 0.6% anesthetic oral rinse rinse

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • ACTIVE INGREDIENT

    0.6 % Phenol

  • PURPOSE

    Anesthetic/Analgesic

  • INDICATIONS & USAGE

    Temporary relief of occasional minor irritation, pain, sore mouth, sore throat, canker sores and teething.

  • WARNINGS

    • Keep out of reach of children. • Not for ingestion.
    • If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    • Shake well prior to use.

    • Use full strength as a mouth rinse, rinsing affected area for 15 seconds and spitting out the remainder of the product.
    • For upper throat, gargle for 15 seconds and spit out.
    • For adults and children over 12 years of age use every 2 hours or as needed; do not use more than 12 times per day.
    • Children ages 4 months to under 12 years of age, apply to affected area with clean swab. Use up to 6 times daily or as directed by physician or dentist.
    • For teething and hard to reach areas, apply directly to area with tip of clean swab, repeat up to 6 times daily.

  • STORAGE AND HANDLING

    Store at room temperature 20°–25°C (68°–77°F) [See USP Controlled Room Temperature].

  • INACTIVE INGREDIENT

    Glycerin, Purified Water, Sodium Bicarbonate and Sodium Borate.

  • SAFE HANDLING WARNING

    TAMPER RESISTANT SEAL–IF SEAL IS BROKEN DO NOT USE.

  • PRINCIPAL DISPLAY PANEL

    NDC 0316-0100-06

    Ulcerease ®

    Anesthetic Mouth Rinse

    Quick pain relief for mouth and upper throat irritations

    CONTAINS: NO SUGAR, NO ALCOHOL, NO ARTIFICIAL DYES OR COLORINGS.
    PLEASANT TO USE.

    Manufactured and Distributed by: Crown Laboratories Inc.,

    Johnson City, TN 37604

    800.334.4286

    www.crownlaboratories.com

    P6028.03

    p602803

  • INGREDIENTS AND APPEARANCE
    ULCEREASE 
    phenol 0.6% anesthetic oral rinse rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-0100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-0100-06178 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/1977
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02203/28/197708/29/2025
    Labeler - Crown Laboratories (079035945)
    Registrant - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture(0316-0100)