Label: DEBACTEROL CANKER SORE PAIN RELIEF- phenolsulfonic acid and sulfuric acid solution

  • NDC Code(s): 62942-101-02, 62942-101-03, 62942-101-12
  • Packager: EPIEN Medical Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 19, 2019

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

  • SPL UNCLASSIFIED SECTION

    DEBACTEROL Canker Sore Pain Relief

  • DESCRIPTION

    Debacterol is a dark brown, semi-viscous liquid. It contains sulfonated phenolics and sulfuric acid, which are tissue denaturants, in an aqueous solution.

  • DOSAGE FORMS & STRENGTHS

    Contains 50% Sulfonated phenolics and 30% sulfuric acid in an aqueous solution.

  • INDICATIONS & USAGE

    Debacterol is indicated in the topical treatment of ulcerating lesions of the oral cavity such as Recurrent Aphthous Stomatitis (Canker Sores). Debacterol provides relief from the pain and discomfort of oral mucosal ulcers. Debacterol is not intended for the treatment of vesicular lesions, such as Cold Sores or Fever Blisters.

  • INSTRUCTIONS FOR USE

    Immediately before applying Debacterol thoroughly dry the ulcerated area of oral mucosa that is to be treated using a cotton-tipped applicator, or by usiing some similar method.

    For Swab:

    After drying the lesion, hold the Debacterol applicator swab with the colored ring end up. Bend the colored ring tip gently to the side until it "snaps" to release the liquid inside. Liquid flows down into the white cotton tip applicator. Apply the Debacterol - coated applicator tip to the dried ulcer area for at least 5 seconds.

    For Vial:

    After drying the lesion, dip the tip of a cotton tipped applicator into the Debacterol, until it is coated with sufficient agent to coat the entire ulcerated area. Apply the Debacterol - coated applicator tip to the dried ulcer area for at least 5 seconds.

    Use a rolling motion to completely cover the entire ulcer bed and ulcer rim. A "stinging" sensation is experienced immediately upon application of the Debacterol to the ulcer. Do not hold the applicator on the ulcer for more than 10 seconds. Debactorol will not harm the normal oral mucosa when used as directed. Thoroughly rinse out the mouth with water and spit out the rinse water. The stinging sensation and ulcer pain will subside almost immediately after the water rinse. One application per ulcer treatment is usually sufficient. However, if the ulcer pain returns shortly after rinsing with water, it is an indication that some part of the ulcer was not covered. Repeat application one more time following the directions above.

    It is not recommended that more than one treatment session be performed on an individual mucosal ulcer.

  • WARNINGS

    Keep out of reach of children. Do not use if allergic to a material that contains sulfur in any form. Because of its nature, prolonged use of Debacterol on normal tissue should be avoided. Debacterol will eventually necrotize and slough all tissue to which it is applied sufficient volume and should be applied carefully. Debacterol may be harmful with swallowed. If ingested do not induce vomiting. Immediately get medical help or contact a Poison Control Center. If eye exposure occurs, immediately remove any contact lenses and irrigate eyes for at least 15 minutes with lukewarm water and contact a physician.

  • PRECAUTIONS

    Debacterol is for use in the oral cavity only. Avoid eye contact. Saftey and effectiveness in pregnant women and children under the age of 12 has not been established.

  • ADVERSE REACTIONS

    Debacterol may cause local irritation upon administration. If excess irritation occurs during use, a rinse with sodium bicarbonate (baking soda) solution will neutralize the reaction (use 0.5 teaspoon in 120ml of water). If condition persists contact a health care professional.

  • HOW SUPPLIED

    Swab contains 0.2 ml of product. (NDC-62942-101-02)

    Vial contains 1.5 ml of product. (NDC-62942-101-03)

  • STORAGE AND HANDLING

    Store at room temperature, 15°C-30°C or 59°F-86°F.

  • Principal Display Panel - DEBACTEROL SINGLE USE APPLICATOR FRONT LABEL

    Debacterol Single Use Applicator - DEBACTEROL SINGLE USE APPLICATOR FRONT LABEL DEBACTEROL SINGLE USE APPLICATOR FRONT LABEL FRONT LABEL

  • Principal Display Panel - DEBACTEROL SINGLE USE APPLICATOR BACK LABEL

    DEBACTEROL SINGLE USE APPLICATOR BACK LABELDEBACTEROL SINGLE USE - DEBACTEROL SINGLE USE APPLICATOR BACK LABEL

  • PRINCIPAL DISPLAY PANEL - DEBACTEROL 12 PACK LABEL

    DEBACTEROL 12 PACK LABELDEBACTEROL 12 PACK LABEL

  • PRINCIPAL DISPLAY PANEL - DEBACTEROL VIAL LABEL

    DEBACTEROL VIAL LABEL DEBACTEROL VIAL LABEL

  • PRINCIPAL DISPLAY PANEL - DEBACTEROL VIAL BOX LABEL

    DEBACTEROL VIAL BOX LABEL

  • INGREDIENTS AND APPEARANCE
    DEBACTEROL CANKER SORE PAIN RELIEF 
    phenolsulfonic acid and sulfuric acid solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62942-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOLSULFONIC ACID (UNII: L74LRO149A) (PHENOLSULFONIC ACID - UNII:L74LRO149A) PHENOLSULFONIC ACID0.5 g  in 1 mL
    SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID0.3 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 0.2 g  in 1 mL
    Product Characteristics
    Colorbrown (Dark) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62942-101-1212 in 1 BOX09/01/1996
    1NDC:62942-101-020.2 mL in 1 APPLICATOR; Type 6: Drug/Biologic Combination
    2NDC:62942-101-031 in 1 BOX09/01/1996
    21.5 mL in 1 VIAL, GLASS; Type 6: Drug/Biologic Combination
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/01/1996
    Labeler - EPIEN Medical Inc (128678765)
    Establishment
    NameAddressID/FEIBusiness Operations
    EPIEN Medical Inc128678765manufacture(62942-101)