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
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Updated December 1, 2020
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- SPL UNCLASSIFIED SECTION
- DOSAGE FORMS & STRENGTHS
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.
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.
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.
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.
- ADVERSE REACTIONS
- HOW SUPPLIED
- STORAGE AND HANDLING
- Principal Display Panel - DEBACTEROL SINGLE USE APPLICATOR FRONT LABEL
- Principal Display Panel - DEBACTEROL SINGLE USE APPLICATOR BACK LABEL
- PRINCIPAL DISPLAY PANEL - DEBACTEROL 12 PACK LABEL
- PRINCIPAL DISPLAY PANEL - DEBACTEROL VIAL LABEL
- PRINCIPAL DISPLAY PANEL - DEBACTEROL VIAL BOX LABEL
INGREDIENTS AND APPEARANCE
DEBACTEROL CANKER SORE PAIN RELIEF
phenolsulfonic acid and sulfuric acid solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62942-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENOLSULFONIC ACID (UNII: L74LRO149A) (PHENOLSULFONIC ACID - UNII:L74LRO149A) PHENOLSULFONIC ACID 0.5 g in 1 mL SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID 0.3 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 0.2 g in 1 mL Product Characteristics Color brown (Dark) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62942-101-12 12 in 1 BOX 09/01/1996 1 NDC:62942-101-02 0.2 mL in 1 APPLICATOR; Type 6: Drug/Biologic Combination 2 NDC:62942-101-03 1 in 1 BOX 09/01/1996 2 1.5 mL in 1 VIAL, GLASS; Type 6: Drug/Biologic Combination Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/01/1996 Labeler - EPIEN Medical Inc (128678765) Establishment Name Address ID/FEI Business Operations EPIEN Medical Inc 128678765 manufacture(62942-101)