MATERIAL SAFETY DATA SHEET

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MSDS – Debacterol® Canker Sore Pain Relief FM-134,A 03/09
Page 1 of 4
MATERIAL SAFETY DATA SHEET
(In accordance with OSHA 29 CFR 1910.1200, ANSI Z 400.1-2003)
SECTION 1: COMPANY AND CHEMICAL INFORMATION
PRODUCT NAME: DEBACTEROL® Canker Sore Pain Relief
MANUFACTURER NAME AND ADDRESS:
EPIEN Medical, Inc.
4225 White Bear Parkway
Suite 600
St. Paul, MN. 55110
FOR PROFESSIONAL USE ONLY
EPIEN MEDICAL CUSTOMER SERVICE PHONE NUMBER:
(888) 884-4675 (8:00 a.m. – 4:30 p.m. Central Time)
651-653-3380
WEBSITE: www.epien.com
www.debacterol.com
24 HOUR EMERGENCY PHONE NUMBER:
SafetyCall International (866) 516-0243/(952) 852-4659
SECTION 2: HAZARDS IDENTIFICATION
POTENTIAL ADVERSE HEALTH EFFECTS: 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 mucosal ulcers. Debacterol is not intended
for treatment of vesicular lesions, such as Cold Sores or Fever Blisters. Do not us if allergic to a material that contains sulfur in any form.
DERMAL: When the product is used according to the “instructions for use” on the oral mucosa for the treatment of recurrent apththous stomatitis (oral
ulcers) the product will cause an “eschar” to form over the affected area. Irritation in the form of a “stinging” sensation will be experienced during the
5-10 second application. A water rinse following the application will immediately cause this stinging sensation to disappear.
Product applied to healthy tissue, adjacent to an ulcerated lesion, causes that tissue to temporarily appear white. Tissues will return to a normal
pink color in a matter of hours. Again, when used as directed, no adverse effects are expected. The small amount of acid equivalents contained in
a single product dose is self neutralized after reaction with the ulcer lesion and rinsing.
INGESTION: Harmful if swallowed.
OCULAR: Irritant to eyes.
CHRONIC HEALTH EFFECTS: None known.
CARCINOGENICITY: None of the ingredients are considered to be carcinogenic by IARC, NTP, or OSHA.
TARGET ORGANS: Topical.
PHYSICAL DESCRIPTION: Brown liquid.
ODOR: Smoky creosote odor.
NOTE: This is a medical product, packaged in small quantities, and intended for direct application to the inside of the mouth (for oral ulcers).
SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS
Hazardous ingredients*
Weight %
CAS #
Sulfonated phenolics
30-60 %
1333-39-7 & 50855-43-1
Sulfuric Acid
25-35 %
7664-93-9
Water
Balance
7732-18-5
*all ingredients in quantities >1.0 % that are potentially hazardous per OSHA definitions NE=not established NA=not applicable NDA=no data
available
SECTION 4: FIRST AID MEASURES
INTENDED SKIN CONTACT: 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 healthcare professional. Do not use if the patient is allergic to a
material that contains sulfur in any form.
UNINTENDED SKIN CONTACT: Flush affected area with water. Seek medical attention if irritation develops and persists.
INGESTION: Rinse out mouth and dilute with fluids (no more than 8 ounces in adults and 4 ounces in children).
Do not induce vomiting. Call a healthcare professional or SafetyCall International.
EYE CONTACT: Flush thoroughly with water. If contact lenses present, remove and flush for additional 15 minutes with water, contact a
healthcare professional.
INHALATION: Move to fresh air; seek medical attention if breathing difficulty develops.
MSDS – Debacterol® Canker Sore Pain Relief FM-134,A 03/09
Page 2 of 4
SECTION 5: FIRE FIGHTING MEASURES
SUITABLE EXTINGUISHING MEDIA: Alcohol foam, dry chemical or CO2.
UNSUITABLE EXTINGUISHING MEDIA: Water stream.
UNUSUAL FIRE AND EXPLOSION HAZARDS: Material may spatter when water is first applied.
PROTECTION OF FIREFIGHTERS
HAZARDOUS COMBUSTION PRODUCTS: Carbon monoxide and carbon dioxide, sulfur oxides
SPECIAL PROTECTIVE EQUIPMENT AND PRECAUTIONS FOR FIREFIGHTERS: Use NIOSH/MSHA approved SCBA and bunker or turnout gear.
SECTION 6: ACCIDENTAL RELEASE MEASURES
Steps to be taken in case the material is spilled: Do not attempt to clean up chemical spills without appropriate personal protective
equipment (see section 8). Do not touch or walk through spilled material. Soak material up with inert sorbent (DO NOT use organic materials
such as sawdust), and transfer to plastic containers for disposal. Keep waste out of sewers, watersheds, and waterways.
SECTION 7: HANDLING AND STORAGE
Handling: Avoid eye contact. Avoid skin contact. Avoid breathing mists, sprays or vapors. See comments regarding personal protective
equipment (see Section 8).
Storage: Store upright in a cool, dry, well ventilated area out of direct sunlight. Protect container from damage to avoid spills. Keep containers
tightly closed at all times. Do not reuse container. Store away from incompatible materials (see Section 10). Keep out of reach of children.
SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
Hazardous ingredients*
Sulfonated phenolics
Sulfuric acid
OSHA PEL**
TWA
NE
1.0 mg/m3
OSHA PEL STEL/C
ACGIH TLV TWA
ACGIH TLV STEL/C
NE
NE
NE
0.2 mg/m3
NE
NE
*all ingredients in quantities > 1.0 % (0.1 % for carcinogens) that are potentially hazardous per OSHA definitions
(skin) - indicates harmful amounts may be absorbed through the skin
** Some States enforce the PEL’s that OSHA promulgated in 1989, which were subsequently vacated by the U.S. Supreme
Court. Check with your State OSHA agency to determine which PEL is enforced in your jurisdiction.
NE = not established NA = not applicable NDA = no data available
ENGINEERING CONTROLS: Transient use of small quantities, as directed, is unlikely to require the use of any engineering (ventilation)
controls.
SKIN: Wear chemically resistant gloves (polyethylene) when handling large quantities (i.e., >1 gallon) if splash potential exists.
BODY PROTECTION: Prevent skin contact. Consumer: If spilled on clothing, remove immediately, flush skin area and rinse garment thoroughly.
EYE PROTECTION: Wear goggles and faceshield if potential exists for direct splash to eye tissue.
RESPIRATORY: NIOSH approved respiratory protection is necessary if any of the occupational exposure limits in Section 2 are exceeded. Seek
professional advice prior to respirator selection or use. Follow OSHA respirator regulations (29 CFR 1910.134).
MSDS – Debacterol® Canker Sore Pain Relief FM-134,A 03/09
Page 3 of 4
SECTION 9: PHYSICAL CHEMICAL PARAMETERS
PHYSICAL STATE: Liquid
ODOR: Smoky creosote odor.
FLASHPOINT: None
AUTOIGNITION TEMPERATURE: NE
% VOLATILE BY VOLUME: NA
BOILING POINT: NE
SPECIFIC GRAVITY: NE
SOLUBILITY IN WATER: Miscible
MELTING POINT: NE
APPEARANCE: Brown
VAPOR PRESSURE: NA
FLAMMABLE LIMITS: UEL NA
LEL: NA
VAPOR DENSITY (air=1): >1
EVAPORATION RATE (n-butyl acetate=1): <1
FREEZING POINT: NE
VISCOSITY: NE
BULK DENSITY: NE
PH: <2
SECTION 10: STABILITY AND REACTIVITY
STABILITY: Stable at STP (standard temperature and pressure)
INCOMPATIBILITIES/MATERIALS AND CONDITIONS TO AVOID: Strong oxidizing and reducing agents, potassium
chlorate/perchlorate/permanganate, sodium, lithium, bases, organic material, halogens, metal acetylides, oxides and hydrides, metals (evolves
hydrogen gas). Large quantities of product should not be allowed to contact water.
POSSIBILITY OF HAZARDOUS REACTIONS: Hazardous polymerization will not occur.
HAZARDOUS DECOMPOSITION PRODUCTS: Sulfur oxides
SECTION 11: TOXICOLOGICAL INFORMATION
PRODUCT BASED INFORMATION: When the product is applied to normal, healthy tissue, the product can cause a minor chemical burn with
slight irritation. When the product is used according to product directions, it will cause the intended formation of a small amount of scar tissue
with the potential for local irritation at the application site. Do not use if the patient is allergic to a material that contains sulfur in any form.
INGREDIENT BASED INFORMATION: Call SafetyCall International for additional toxicity information on ingredients.
POSSIBLE TARGET ORGANS: Eyes and skin.
MEDICAL CONDITIONS THAT MAY BE AGGRAVATED BY EXPOSURE: Persons with pre-existing skin disorders may be more susceptible
to the effects of this material. Do not use if the patient is allergic to a material that contains sulfur in any form.
CARCINOGENS: IARC – No*; NTP – None; OSHA – None [* Significant exposure by inhalation to this product is unlikely – IARC has stated
that “occupational exposure to strong-inorganic-acid mists is carcinogenic to humans (Group 1)”.]
SECTION 12: ECOLOGICAL INFORMATION
ECOTOXICITY: Would be expected to be toxic to aquatic
organisms but not with the small quantities contained in a single
product dose.
PERSISTENCE/DEGRADABILITY: NDA
BIOACCUMULATION/ACCUMULATION: NDA
MOBILITY IN SOIL: NDA
SECTION 13: DISPOSAL INFORMATION
DISPOSAL COMMENTS: This material (as packaged) is most likely considered a RCRA hazardous waste (D002, Corrosive). Be aware that the
waste owner has responsibility for final disposal. Regulations may also apply to empty containers, liners or rinsate. Laws may change or be
reinterpreted; state and local regulations may be different from federal regulations. This information applies to materials as manufactured;
contamination or processing may change waste characteristics and requirements
SECTION 14: TRANSPORT INFORMATION
DOT SHIPPING NAME: : Phenolsulfonic acid, liquid
HAZARD CLASS: 8
SUBSIDIARY CLASS: None
UN NUMBER: 1803
PACKING GROUP: II
MARINE POLLUTANT INFORMATION: NDA
MSDS – Debacterol® Canker Sore Pain Relief FM-134,A 03/09
Page 4 of 4
SECTION 15: REGULATORY INFORMATION
CHEMICAL INVENTORIES: All components of this product listed in section 2 are listed on the TSCA inventory list, the DSL/NDSL and the
EINECS.
REPORTABLE QUANTITIES: Sulfuric acid = 1000 lbs.
SARA TITLE III (Superfund Amendments and Reauthorization Act)
Section 302 Extremely Hazardous Materials: Sulfuric acid
Section 304 Notification of Accidental Release: None
Sections 311/312 Hazard Categories: Immediate (acute) Health Effects: Yes
Delayed (Chronic) Health Effects: Yes
Fire Hazard: Yes
Sudden Release of Pressure Hazard: No
Reactivity Hazard: Yes
California Proposition 65 Warning: None
SECTION 16: OTHER INFORMATION
This MSDS replaces all previous versions for this product. Please discard all previous versions as they may contain changed or obsolete
information. The information in this MSDS was obtained from sources we believe are reliable. However, the information is provided without any
representation or warranty, expressed or implied, regarding its accuracy or completeness. Prepared by SafetyCall International, PLLC,
Bloomington, MN USA.

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