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MATERIAL SAFETY DATA SHEET
National Fire Protection Association (NFPA) Rating: Health: 1 Flammability: 3 Reactivity: 0 Special: 0
TELEPHONE CONTACTS:
Product Technical and Medical Information: (800) 433-8871
Transportation Emergency 24-Hour Response (CHEMTREC): (800) 424-9300
SECTION 1: PRODUCT IDENTIFICATION
Compound Name: M.D. FORTE庐 Glycare Perfection Gel
Chemical Class: N/A
Manufacturer's Name: Allergan, Inc.
Address: 2525 Dupont Drive
Irvine, CA 92612
June 20, 2001 (Supersedes September 17, 1999)
Preparation Date:
SECTION 2: COMPOSITION/HAZARDOUS INGREDIENTS
Percent Exposure Limits in Air
Chemical Name CAS Number (by weight) OSHA PEL ACGIH - TLV
Ethyl Alcohol 64-17-5 35.0 1000 ppm 1000 ppm
SECTION 3: HAZARDS IDENTIFICATION
Emergency Overview: M.D. FORTE庐 Glycare Perfection Gel may cause moderate to severe
irritation to eyes. Do not allow contact with eyes. Product is flammable. Keep away from flames or
other ignition sources.
Potential Health Effects
Eye Contact: Contact with the eyes may result in moderate to severe irritation.
Skin Contact: Prolonged contact with skin may result in moderate irritation.
Inhalation: Not likely to occur under normal conditions of use.
Ingestion: May cause irritation, nausea and vomiting if swallowed.
M.D. FORTE庐 Glycare Perfection Gel
June 20, 2001
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M.D. FORTE庐 Glycare Perfection Gel has been shown to be non-
Chronic Effects:
sensitizing, non-phototoxic and non-photoallergic, and non-comedogenic in
humans.
No ingredient in this product is regulated or listed as a carcinogen by OSHA,
IARC, or NTP.
Conditions Which May None known.
Aggravate Exposure:
SECTION 4: FIRST AID MEASURES
Eye Contact: If contact occurs, immediately flush eyes with plenty of water for at least 15
minutes. Obtain medical attention immediately if irritation develops.
Skin Contact: Wash skin with soap and water. If irritation or other symptoms develop, consult
a physician.
Inhalation: Not likely to occur under normal conditions of use.
Ingestion: Consult a physician or poison control center immediately.
SECTION 5: FIRE FIGHTING MEASURES
O
Flash Point and (Method): 82 F (Pensky Martens Closed Cup)
Flammable Limits: Not determined
Autoignition Temperature: No data for this product
Fire-Extinguishing Materials: Use extinguishing media suitable for materials supporting combustion
such as water fog, CO2, foam or dry chemical.
Firefighting Procedures: Use self-contained breathing apparatus in enclosed or confined spaces
or as otherwise needed.
Unusual Fire and Explosion Product is flammable. Keep away from flames or other ignition
Hazards: sources.
SECTION 6: ACCIDENTAL RELEASE MEASURES
Sweep up or take up with absorbent material and wash with water. If large quantities are spilled, flush
spill area with water.
SECTION 7: HANDLING AND STORAGE
Handling: Avoid unintentional contact with skin surfaces. Do not allow contact with eyes.
Wash thoroughly after handling. Observe all labeling precautions and protective
equipment recommendations.
Storage: Store in a cool, dry location out of direct sunlight. Keep container closed when
not in use.
M.D. FORTE庐 Glycare Perfection Gel
June 20, 2001
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SECTION 8: EXPOSURE CONTROLS AND PERSONAL PROTECTION
Engineering Controls: None necessary for normal product handling.
Respiratory Protection: None necessary for normal product handling.
Eye Protection: None necessary for normal product handling. Avoid eye contact.
Protective Clothing: None necessary for normal product handling. Clinicians repeatedly
applying the product to patients should wear latex gloves when handling
M.D. FORTE庐 Glycare Perfection Gel
Hygienic Work Practices: Wash hands thoroughly after handling. No eating, drinking, or smoking in
area.
SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES
Vapor Density (Air = 1): No data on this product
O
Boiling Point: 80 C (Ethyl Alcohol)
Solubility in Water: Dispersible
O
Specific Gravity 0.95 鈥? 0.97 @ 25 C
O
pH: 3.6 鈥? 3.9 @ 25 C
O
Vapor Pressure (mm Hg at 20掳 C): 30 mm @ 25 C (Ethyl Alcohol)
Appearance and Odor: Clear to Slightly Hazy Gel With a Mild Alcohol Odor
SECTION 10: STABILITY AND REACTIVITY
General: This product is stable and hazardous polymerization will not occur.
O
Incompatible Materials and Store away from oxidizers and heat. Store below 30 C.
Conditions to Avoid:
Hazardous Decomposition : Carbon Dioxide and/or Carbon Monoxide.
SECTION 11: TOXICOLOGICAL INFORMATION
The oral LD50 for M.D. FORTE庐 Glycare Perfection Gel, based on its alcohol content,
Oral:
can be calculated to be between 7.06 and 10.6 g/Kg when tested in rats.
Reproduction: Not Tested
Mutagenicity: Not Tested
M.D. FORTE庐 Glycare Perfection Gel
June 20, 2001
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Cumulative Irritation Testing: Twenty-three subjects participated in the study and were
Skin:
patch tested, on the upper back, with each of the test products daily for 14 days.
Approximately 0.2 ml of each test material was applied onto a 2 cm x 2 cm
semi-occlusive patch which was left in place for 24 hours Monday through Friday and 48
hours on Saturday for two consecutive weeks. Test sites were evaluated daily for
erythema on a 0 (none) to 4 (severe) scale directly after patch removal and the scores
were calculated via summation of the irritation values for each day. Maximum score per
product was 1176.
Results/Conclusion: Table 1 depicts the cumulative irritation data curve for the
experimental formulas tested. Based on the data obtained and the product鈥檚 pH level of
3.8, M.D. FORTE庐 Glycare Perfection Gel can be considered practically non-irritating
and suitable for consumer use.
Table 1
Conc. pH Cumulative Value
10.0% 2.00 768/1176
10.0% 2.50 746/1176
10.0% 3.00 631/1176
10.0% 3.25 404/1176
10.0% 3.80 38/1176
15.0% 3.80 14/1176
20.0% 3.80 37/1176
10.0% 4.40 18/1176
In Vitro Acute Ocular Irritation Assay M.D. FORTE庐 Glycare Perfection Gel was
Ocular:
applied to a semi-permeable cellulose membrane and placed into a cubette filled with a
protein reagent. The sample reacts with the reagent producing turbidity, the turbidity
measured, and the irritancy potential projected based on a correlation of a standard set
of known points produced by the positive control.
Results/Conclusion: Due to the sensitivity of the assay to acid based products M.D.
FORTE庐 Glycare Perfection Gel produced a mild to moderate amount of irritation.
However, in comparison to other commercially available products containing Glycolic
Acid (with a known history of safe use in the market place) this product鈥檚 irritation
potential was considered either equal to or less than those currently being marketed.
200 Subject Repeat Insult Patch Teat: Induction Period - Approximately 0.2 ml of M.D.
Sensitization:
FORTE庐 Glycare Perfection Gel was applied to a 2 cm x 2 cm square of Webril cotton
fabric (affixed to Scanpor semi-occlusive surgical tape) and placed on the back of each
subject between the scapulae and waist, adjacent to the spinal mid-line. The first
induction patch was worn for a 48 hour period and was removed by a technician just
prior to application of the second induction patch. Induction patches 2 through 9 were
remove 24 hours after each application and the test site was allowed to rest for an
additional 24 hours prior to repatching. All test sites were graded for erythema and
edema prior to reapplication of the next patch. Rest Period - After the last induction
reading, no patches were applied for 10 - 14 days. Challenge Period - After the rest
period, subjects were patched M.D. FORTE庐 Glycare Perfection Gel, as outlined
above, at a naive site; Patches were removed by a technician after 48 hours;
Erythema/edema were evaluated upon removal and at 96 hours post application.
Results/Conclusion: Scattered, transient, barely perceptible to moderate non-specific
irritation was observed in approximately 5% (11/207) of the subjects during the induction
and/or challenge periods. None of these non-specific responses was considered to be
irritant or allergic in nature
M.D. FORTE庐 Glycare Perfection Gel
June 20, 2001
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SECTION 12: ECOLOGICAL INFORMATION
Persistence and Degradability: Readily and rapidly degradable.
Aquatic Toxicity: No data available on this product.
SECTION 13: DISPOSAL CONSIDERATIONS
For small amounts of M.D. FORTE庐 Glycare Perfection Gel, discard as ordinary trash. For
large quantities, contact Allergan for information on disposal options.
SECTION 14: TRANSPORT INFORMATION
Domestic (Land, D.O.T.)
Consumer Commodity (containing flammable solution), ORM-D
International (Air, I.C.A.O.)
ID 8000 Consumer Commodity (containing flammable solution), Class 9
International (Water, I.M.O.)
UN 1993 Flammable Liquid, N.O.S. (Ethyl Alcohol Solution), Class 3.3, Pkg. Group III
o
(Flash pt. 82 F), Limited Quantity
SECTION 15: REGULATORY INFORMATION
TSCA (Toxic Substances Control Act):
Components of this product are listed on the TSCA Inventory.
CERCLA (Comprehensive Environmental Response, Compensation, and Liability Act:
This product contains no components subject to reporting or notification requirements.
SARA Title III (Superfund Amendments and Reauthorization Act):
311/312 Hazard Categories: Immediate Health, Fire
313 Reportable Ingredients: None
WHMIS (Workplace Hazardous Materials Information System - Canada):
Not Regulated (Product is regulated by the Food and Drugs Act)
SECTION 16: OTHER INFORMATION
____________
The preceding information is based on available data and is believed to be correct. However, no
warranty is expressed or to be implied regarding the accuracy of this information, the results to
be obtained from the use thereof, or the hazards connected with the use of the material. Since
the information contained herein may be applied under conditions beyond our control and with
which we may be unfamiliar, we do not assume any responsibility for the results of its use. This
information is furnished upon the condition that the persons receiving it shall make their own
determinations of the effects, properties, and protections which pertain to their particular
conditions.
M.D. FORTE庐 Glycare Perfection Gel
June 20, 2001
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