Maxilene 5

MSDS Information

RGR PHARMA LTD.
MATERIAL SAFETY DATA SHEET (MSDS)


Maxilene 4

Maxilene 5

 

1. PRODUCT & COMPANY IDENTIFICATION
Product Identification:
Maxilene 5 (lidocaine 5%) Topical Anesthetic Cream
Manufacturer:
Ferndale Laboratories, Inc.
780 West Eight Mile Road
Ferndale, Michigan 48220-2498
U.S.A.
Telephone Number:
1-248-548-0900
Fax Number:
1-248-548-8427

2. INGREDIENTS/IDENTITY INFORMATION
Ingredient Sequence Number:
01
Ingredient:
Lidocaine
CAS Number:
137-58-6
RTECS Number:
AN7525000
Ingredient Sequence Number:
02
Ingredient:
Benzyl Alcohol
CAS Number:
100-51-6
RTECS Number:
DN315000
Ingredient Sequence Number:
03
Ingredient:
Carbomer 940
CAS Number:
9003-01-4
RTECS Number:
AT4680000
Ingredient Sequence Number:
04
Ingredient:
Cholesterol
CAS Number:
57-88-5
RTECS Number:
FZ8400000
Ingredient Sequence Number:
05
Ingredient:
Hydrogenated Soy Lecithin
CAS Number:
97281-48-6
RTECS Number:

Ingredient Sequence Number:
06
Ingredient:
Isopropyl Myristate
CAS Number:
9005-63-6
RTECS Number:
WG2932500
Ingredient Sequence Number:
07
Ingredient:
Polysorbate 80
CAS Number:
9005-63-6
RTECS Number:
WG2932500
Ingredient Sequence Number:
08
Ingredient:
Propylene Glycol
CAS Number:
57-55-6
RTECS Number:
TY2000000
Ingredient Sequence Number:
09
Ingredient:
Vitamin E Acetate
CAS Number:
7695-91-2, 58-95-7
Ingredient Sequence Number:
10
Ingredient:
Water
CAS Number:
7732-18-5
RTECS Number:
ZC0110000

3. HAZARD IDENTIFICATION
Emergency Overview
Appearance:
White to off-white, yellowish cream
Caution!
Possible eye, skin and respiratory tract irritation. May cause topical analgesia. Ingestion is toxic.
Hazardous Materials Identification (HMIS):
Health - 1    Flammability - 1    Reactivity - 0
National Fire Protection Association (NFPA):
Health - 1    Flammability - 1    Reactivity - 0
Potential Health Effects
Routes of Exposure:
Inhalation:
Unlikely route of exposure. May cause tingling/numbness in exposed areas (parasthesia). May produce a reduced heart rate and reduction in blood pressure with a resulting feeling of dizziness. May cause irritation to the respiratory tract. Symptoms may include coughing, sore throat, labored breathing, and chest pain.
Skin:
May cause numbness. May be absorbed through skin with possible side effects. May cause irritation or sensitization in sensitive individuals. Prolonged and/or repeated contact may cause defatting of the skin and dermatitis
Ingestion:
May produce numbness of the tongue and anesthetic effects on the stomach. May cause irritation of the digestive tract. Symptoms may include nausea, vomiting and diarrhea.
Eye:
May cause numbness. May cause eye irritation. May cause excessive watering of the eye (lacrimation).
Chronic Exposure:
Repeated exposure of animals to high levels of lidocaine produces adverse effects on the: liver, central nervous system. Prolonged or repeated exposure may cause dermatitis.

4. FIRST AID MEASURES
Take precautions to ensure your own health and safety before attempting rescue and providing first aid.
Inhalation:
Unlikely route of exposure. Remove from exposure to fresh air immediately. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical aid if cough or other symptoms appear.
Eye:
Flush with copious amounts of eyewash solution or clean water for at least 15 minutes. Assure adequate flushing by occasionally lifting the upper and lower eyelids with fingers. Obtain medical attention.
Skin:
Flush with copious amounts of soap and water for at least 15 minutes. Remove contaminated shoes and clothing. Get medical aid if irritation develops or persists. Wash clothing before reuse. Thoroughly clean shoes before reuse.
Ingestion:
If victim is conscious and alert, give 2-4 cupfuls or milk or water. Never give anything by mouth to an unconscious person. Get medical aid.
Note to Physician:
Treat symptomatically and supportively.

5. FIRE FIGHTING
Flash Point:
Not determined
Autoignition Temperature:
Not determined
Flammable or Explosive Limits (Approximate percent by volume in air) Lower Explosive Limit:
Not determined
Upper Explosive Limit:
Not determined
Extinguishing Media:
Foam, water spray (fog), dry chemical carbon dioxide and vaporizing liquid type fire extinguishing agents may all be suitable for extinguishing fires involving this type of product, depending on size or potential size of fire and circumstances related to the situation. Plan fire protection and response strategy through consultation with local fire protection authorities or appropriate specialists.
Fire Fighting Procedures:
Wear a self-contained breathing apparatus (SCBA) equipped with a full facepiece and operated in a pressure-demand mode (or other positive pressure mode) and approved protective clothing. Personnel without suitable respiratory protection must leave the area to prevent significant exposure to hazardous gases from combustion, burning, or decomposition. In an enclosed or poorly ventilated area, wear SCBA during cleanup immediately after a fire as well as during the attack phase of firefighting operations. During a fire, irritating and highly toxic gases may be generated by thermal decomposition or combustion.
Hazardous Decomposition Products:
Carbon irritating and highly toxic fumes and gases, carbon dioxide.

6. ACCIDENTAL RELEASE MEASURES
Steps To Be Taken In Case Material Is Released Or Spilled:
Ensure suitable personal protection during removal of spills. Scrape up material into waste container or absorb with dry sand or oil absorbent. Clean spill with detergent solution or safety solvent. Provide adequate ventilation during cleanup procedures.

7. HANDLING AND STORAGE
Handling:
Wash thoroughly after handling. Wash hand before eating. Remove contaminated clothing and wash before reuse. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation.
Storage:
Store in a tightly closed container. Keep from contact with oxidizing materials. Store in a cool, dry, well-ventilated area away from incompatible substances.
Waste:
Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Observe all federal, state and local environmental regulations.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Exposure limit for total product:
Not available
Ventilation:
A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersions of it into the general work area.
Respiratory Protection:
Not expected to require personal respirator usage.
Skin Protection:
Wear appropriate protective gloves to prevent skin exposure. Wear appropriate protective clothing to prevent skin exposure.
Eye Protection:
Wear appropriate protective eyeglasses or chemical safety goggles as described by OSHA’s eye and face protection regulations in 29 CFR 1910.134. Maintain eye wash fountain and quick-drench facilities in work area.
Personal Hygiene:
Clean PPE and work clothing contaminated with product prior to use.

9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:
White to off-white, yellowish cream.
Viscosity:
Not less than 5000 cP
pH (10% aqueous slurry):
8 to 10
Solubility in water:
Slightly soluble

10. STABILITY AND REACTIVITY
Stability:
Stable under ordinary conditions of use and storage. Hazardous polymerization will not occur.
Materials to avoid:
Oxidizing agents, acids, bases

11. TOXICOLOGICAL INFORMATION
Nature of Hazard and Toxicity Information
Lidocaine:
Oral median lethal dose 317 mg/kg (rat)
Benzyl Alcohol:
Draize test, rabbit skin: 100 mg/24H Moderate; oral, mouse: LD50 = 1360 mg/kg; Oral, rabbit: LD50 = 1040 mg/kg Oral, rat: LD50 =1230 gm/kg; Skin, rabbit: LD50 2 gm/kg. Not listed as a carcinogen by ACGIH, IARC, NIOSH, NTP, or OSHA. Mutagenicity: DNA repair (Bacteria= Bacillus subtilis) = 21 mg/disc Mutation in microorganisms (Mouse lymphocyte) = 250 mg/L Other studies: Standard Draize test (skin, Human) = 16 mg/48H; Mild Standard Draize test (skin, rabbit) = 100 mg/24H; Moderate.
Carbomer 940:
IARC: Group 3 carcinogen Oral mouse: LD50 = 4600 mg/kg; Oral, rat: LD50 = 2500 mg/kg
Cholesterol:
No LD50/LC information found relating to normal routes of occupational exposure. Investigated as tumorigen, mutagen, reproductive effector. NTP Carcinogen – Known: No Anticipated: No IARC Category: 3
Hydrogenated Soy Lecithin:
This product can be considered as nontoxic for human beings and animals.
Isopropyl Myristate:
Draize test, rabbit, skin: 426 mg/24H Mild Draise test, rabbi,t skin: 100 mg/24 H Severe Oral, mouse LD50 = 49700 mg/kg Skin, rabbit: LD50 = 5 g/kg Carcinogenicity: Not listed by ACGIH, IARC, NIOSH, NTP, or OSHA.
Polysorbate 80:
Irritation Data (std Draize, rabbit): Eye = 150 mg, mild Toxicity Data: IPR-RAT LD50: 6804 mg/kg IVN-RAT LD50: 1790 mg/kg ORL-RAT LD50: 34500 ul/kg ORL-MUS LD 50: 25 g/kg IPR-MUS LD50: 7600 mg/kg IVN-MUS LD50: 4500 mg/kg Investigated as a tumorigen, mutagen, reproductive effector.
Propylene Glycol:
Oral LD50 Rat >5 g/kg Dermal LD50 Rabbit >2 g/kg. Skin irritation: This material is expected to be slightly irritating. Eye irritation: This material is expected to be slightly irritating. Reproductive and Developmental Toxicity: No reproductive or developmental risk to humans is expected from exposure to this product. Developmental Toxicity: This chemical has been tested in laboratory animals and no evidence of teratogenicity, embryotoxicity or fetotoxicity was seen. Mutagenicity: This material has been shown not to be mutagenic.
Vitamin E Acetate:
Acute oral, single dose, rat: >16,000 mg/kg Acute, dermal, single dose, rat: >3000 mg/kg Irritation eye, single dose, rabbit: non-irritating Irritation skin, single dose, rabbit: practically non-irritating

12. ECOLOGICAL INFORMATION
Nature of Hazard and Ecological Information
Lidocaine:
Low toxicity to aquatic organisms. LC0 (zebra fish)(96 hour) 106 mg/L). EC50 (Daphnia magna) (48 hour) 112 mg/L EC 50 (green algae (72 hour) 780 mg/L EC50 (Microtox test) (15 minutes) > 1000 mg/L
Benzyl Alcohol:
Flathead Minnow: LC50 = 46.41 mg/L; 96 hr.; Static, Soft Flathead Minnow: LC50 = 59.30 mg/L, 96 hr.; Static, Hard Bluegill/Sunfish: LC50 = 25.05 mg/L 96 hr.; Static, Hard Goldfish: LC50 = 64.74 mg/L, 96 hr.; Static, Hard WasteWater flea Daphnia: EC50 = 400.0 mg/L 48 hr.; Unspecified/Water flea Daphnia: EC50 = 23.0 mg/L; 48 hr.; Unspecified/Bacteria Phytobacterium phosphoreum: EC50 = 71.4 mg/L 5,15,30 minutes Microtox test, 15 degrees Clog Pow: 1.1 Fish toxicity: LC5- (48-96 hr) flathead minnow 770-460 mg/L, static bioassay at 18-22°C
Carbomer 940:
Bluegill/Sunfish: LC50 = 580-2000 mg/L; 96 hr; Unspecified/Water flea Daphnia: EC50 = 168-280 mg/L; 96 hr; Unspecificed
Cholesterol:
No information found.
Hydrogenated Soy Lecithin:
Ecological completely harmless.
Isopropyl Myristate:
No information found.
Polysorbate 80:
No information found.
Propylene Glycol:
Goldfish 224 hr LC50: >5000 mg/L (Measured, Static) Rainbow Trout (Salmogairdneri) Lethal Dose (24 hr Exposure) >50000 mg/L (Nominal, Static) Brine Shrimp 24 hr LC50: >10000 mg/L (Nominal, Static) Daphine Magna, 48 hr EC50: >10000 mg/L (Nominal, Static)
Vitamin E Acetate:
n-octanol/water partition coefficient: 12.2
Clean Air Act:
This product does not contain any hazardous air pollutants. This product does not contain any Class 1 Ozone depletors. This product does not contain any Class 2 Ozone depletors.

13. DISPOSAL RECOMMENDATIONS
State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance with federal, state and local requirements.

14. TRANSPORT INFORMATION
Not regulated

15. REGULATORY INFORMATION
U.S. Federal Regulations: The following information may be useful in complying with various state and federal laws and regulations under various environmental statutes:
Threshold Planning Quantity (TPQ),
EPA Regulation 40 CFR 355 (SARA sections 301– 304) No TPQ for product or any constituents greater than 1% or 0.1% (carcinogen).
Toxic Chemical Release Reporting,
EPA Regulation 40 CFR 372 (SARA section 313) No toxic chemical is present in quantities greater than 1% or 0.1% (carcinogen).

16. OTHER INFORMATION
Date Issued:
September 2, 2004
Supersedes Date:
March 3, 2003
MSDS
3005, Maxilene 5 (lidocaine 5%) Topical Anesthetic Cream

Notice: The information in this data sheet has been assembled by the manufacturer based on its own studies and on the work of others. The manufacturer makes no warranties, expressed or implied, as to the accuracy, completeness or adequacy of the information contained herein. The manufacturer shall not be liable (regardless of fault) to the vendee, the vendee’s employees or anyone for any direct, special or consequential damages arising out of or in connection with the accuracy, completeness, adequacy or furnishing of such information. Persons obtaining shall make their own determination as to the suitability of the product for their particular use.