Material Safety Data Sheet
Rx Pharmaceutical Product Regulated by the FDA
Product Name: Rx Tretinoin Cream, 0.1%
Rx Tretinoin Cream, 0.05%
Rx Tretinoin Cream, 0.025%
Synonyms: Generic for Brand Name Retin-A?br>
Category: Topical Acne Gel
Perrigo Product Number: Rx Tretinoin Cream, 0.1% 0A4
Rx Tretinoin Cream, 0.05% 2R6
Rx Tretinoin Cream, 0.025% 4R9
This is a pharmaceutical product manufactured in accordance with FDA requirements. The
information contained on this MSDS is based primarily on a review of the active pharmaceutical
ingredient(s). This product has not been tested as a whole.
SECTION I ?MANUFACTURER INFORMATION
Distributor:
Perrigo Company Emergency Number: 269-673-7600
515 Eastern Avenue
Allegan, MI 49010 MSDS Prepared by: Perrigo Corporate EHS
269-673-8451 MSDS Date: 03/05/08
www.perrigo.com MSDS Version: 01
SECTION II ?INFORMATION ON PRIMARY INGREDIENTS
Active Ingredients: Amount CAS #
Tretinoin 0.1%, 0.05%, 0.025% 302-79-4
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Inactive Ingredients:
Stearic Acid 10-20% 57-11-4
SECTION III - PERRIGO SAFETY & HEALTH RATINGS (HMIS?
Health: 2 Flammability: 1 Reactivity (Physical Hazards): 0
HMIS?Ratings: * = Chronic Health Hazard
0 = Minimal 1 = Slight 2 = Moderate 3 = Severe 4 = Extreme
SECTION IV - EMERGENCY/FIRST AID PROCEDURES:
CONTACT A POISON CONTROL CENTER AND/OR PHYSICIAN FOR OVEREXPOSURE
Eyes: Flush immediately with large amounts of water for at least 15 minutes.
Ingestion. Contact a doctor if irritation or other symptoms develop. Never give anything by
mouth to an unconscious person. Do not induce vomiting unless directed by medical personnel.
Inhalation: Remove to fresh air; support breathing (give oxygen or artificial respiration).
Skin: If overexposed, remove contaminated clothing; wash skin with mild soap and water.
SECTION V ?HEALTH HAZARD INFORMATION (Occupational Exposure)
Primary Route(s) of Entry: Dermal medication. Low or incidental inhalation or ingestion
hazard from occupational exposure. Handling this product in its final form presents minimal risk
from occupational exposure.
Rx Tretinoin Cream, 0.1%, 0.05%, 0.025% Page 2 of 3
Overexposure and Adverse Effects: The skin of certain sensitive individuals may become
excessively red, edematous, blistered or crusted. Temporary hyper-or hypopigmentation may
occur with overexposure. Central nervous system depression, dizziness, nausea or vomiting may
occur.
Target Organs: Skin & liver
Chronic Effects: Some people may be hypersensitive. Material is a photosensitizer.
Inhalation: May cause irritation to the upper respiratory tract. Inhalation of high vapor
concentrations can cause CNS -depression and narcosis.
Eyes: May cause irritation.
Skin: Direct contact may cause redness, dermatitis or skin rashes; skin sensitization or an
allergic reaction; material is a photosensitizer- causes sensitization to light.
Ingestion: Not anticipated during occupational exposure.
Medical Conditions Potentially Aggravated: Avoid direct sun exposure and weather extremes
such as wind and cold as much as possible whenever using this product. Avoid sunlamps
entirely while using this product. Do not use this product if sunburned or if the individual has
eczema or other chronic skin conditions. Product should not be used if inherently sensitive to
sunlight, or while taking other drugs that increase sensitivity to sunlight. Product should be kept
away from the eyes, the mouth, angles of the nose and mucous membranes.
Oral LD-50 Rat for API: 1960 mg/kg
Typical Adult Therapeutic Dose: Apply once per day.
Carcinogenicity: N/A
Pregnancy or Reproductive Effects: Pregnancy Category C. Risk cannot be ruled out.
Fetotoxic in rabbits. Do not use if you are pregnant, attempting to become pregnant or are at a
high risk of pregnancy.
SECTION VI ?PRECAUTIONS FOR SAFE HANDLING & USE
Handling & Storage: Store per labeled instructions. Keep away from heat, spark and open
flame. Keep in a well-ventilated place. Store at temperatures not exceeding 86F. Keep
container tightly closed and away from sources of ignition. No smoking. Ensure adequate
ventilation. Vapors may form explosive mixtures with air.
Personal Protective Equipment for Occupational Exposures:
Respiratory Protection: When working with small quantities in well-ventilated area,
respiratory protection is generally not required. If engineering controls are not sufficient
to control exposure, NIOSH-approved respiratory protection should be worn in
accordance with a comprehensive respiratory protection program (OSHA).
3
Perrigo OEL for API: Tretinoin = 0.5 礸/m (8 Hour TWA)
Skin Protection: Normal Hygiene & Gloves
Eye Protection: Normal Hygiene & Safety Glasses
Other Protective Clothing: As needed to prevent repeated/prolonged contact
Work/Hygiene Practices: Handling this product in its final form presents minimal risk
from occupational exposure. Wash hands after handling this product and before eating,
smoking, using the lavatory and at the end of the day.
SECTION VII ?PHYSICAL/CHEMICAL PROPERTIES
Appearance & Odor: Light yellow cream
Specific Gravity (H2O = 1): N/A Flash Point: NA
Vapor Pressure (mm Hg 20癈): N/A Boiling Point: N/A
Vapor Density (AIR = 1): N/A Evaporation Rate: N/A
Molecular Weight: N/A Solubility in Water: N/A
pH: 2.7-4.7 Solubility in Alcohol: N/A
Viscosity @ 25篊: N/A Solubility in Oil: N/A
% Volatile by Volume: N/A Melting Point: N/A
SECTION VIII ?FIRE AND EXPLOSION HAZARD DATA
Extinguishing Media: Water Spray or Foam, Dry Chemical, or Carbon Dioxide Fire
Extinguisher.
Rx Tretinoin Cream, 0.1%, 0.05%, 0.025% Page 3 of 3
Special Fire Fighting Procedures: Wear appropriate equipment, including self-contained
breathing apparatus during fire fighting activities.
Hazardous Combustion Products: Toxic, corrosive or flammable thermal decomposition
products may be encountered when this product is exposed to fire.
Flash Point (if Liquid): NA Auto-Ignition Temperature: N/A
LEL: NA UEL: NA Unusual Fire/Explosion Hazards: N/A
SECTION IV ?REACTIVITY DATA (Physical Hazards)
Stabile: YES
Conditions/Materials to Avoid: Avoid contact with heat, sparks, flames or other sources of
ignition. May form flammable/explosive vapor-air mixtures. Avoid strong oxidizers and strong
acids.
Hazardous Polymerization: Should Not Occur
SECTION X - SPILLS, RELEASES & DISPOSAL
Spills or Releases: Wipe up or absorb and put in appropriate container. Wash area.
Neutralizing Agent: N/A
Waste Disposal Methods: Dispose in accordance with applicable local, state and federal
regulations. Do not dump into sewers on the ground, or into any body of water. Dispose of
contaminated packaging as unused product.
SECTION XI - CONTAINER LABELING
Precautionary Labeling: Federal law prohibits dispensing without a prescription. For
dermatologic use only. Not for ophthalmic use.
IMO Hazard Class#: Not Available
UN/NA#: Not Available
Hazard Classification: Not Available
DOT Name: Not A vailable
Shipping Instructions: Not Available
SECTION XII - ENVIRONMENTAL RISKS
Aquatic Toxicity: Not Available
Biodegradability: Not Available
Partition Coefficient: Not Available
SECTION XIII - REGULATORY INFORMATION
OSHA Regulations: 29 CFR 1910 for occupational exposure
DOT Regulations: Consult 49 CFR 172.101 and applicable state and local regulations
EPA Regulations: Consult 40 CFR and applicable state and local regulations
FDA Regulations: Prescription Medication
DISCLAIMER OF LIABILITY
As the conditions or methods of use are beyond our control, we do not assume any responsibility
and expressly disclaim any liability for any use of this material. Information contained herein is
believed to be true and accurate but all statements or suggestions are made without warranty,
express or implied, regarding accuracy of the information, the hazards connected with the use of
the material or the results to be obtained from the use thereof. Compliance with all applicable
federal, state and local laws and regulations remains the responsibility of the user.
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