DEBACTEROL CANKER SORE PAIN RELIEF- phenolsulfonic acid

DEBACTEROL CANKER SORE PAIN RELIEF- phenolsulfonic acid and sulfuric

acid solution

EPIEN Medical Inc

Reference Label Set Id: 22b16c69-598a-432b-aa23-971b4e9e7ad5

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.

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DEBACTEROL Canker Sore Pain Relief

Debacterol is a dark brown, semi-viscous liquid. It contains sulfonated phenolics and

sulfuric acid, which are tissue denaturants, in an aqueous solution.

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

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.

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.

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.

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.

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.

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

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

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

FRONT LABEL

EPIEN Medical Inc

Active Ingredient/Active Moiety

Ingredient Name

Basis of

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

NDC:62942-

101-12

12 in 1 BOX 09/01/1996

NDC:62942-

101-02

0.2 mL in 1 APPLICATOR; Type 6: Drug/Biologic

Combination

NDC:62942-

101-03

1 in 1 BOX 09/01/1996

1.5 mL in 1 VIAL, GLASS; Type 6: Drug/Biologic

Combination

Marketing Information

Marketing