Note: Ingredients listed on restricted chemical lists
EC/CAS
232-554-6/9000-70-8
Name of the chemical
gelatin
Concentration
Proprietary
EC/CAS
200-289-5/56-81-5
Name of the chemical
glycerol
Concentration
Proprietary
EC/CAS
232-307-2/8002-43-5
Name of the chemical
Lecithins
Concentration
Proprietary
EC/CAS
500-038-2/25322-68-3
Name of the chemical
polyethyleneglycol
Concentration
038-2
EC/CAS
200-338-0/57-55-6
Name of the chemical
1,2-propanediol
Concentration
Proprietary
EC/CAS
13463-67-7
Name of the chemical
Reaction mass of titanium dioxide and silver chloride
Concentration
236-675-
EC/CAS
232-296-4
Name of the chemical
Peanut oil, extracts and derivatives
Concentration
Proprietary
EC/CAS
215-168-2
Name of the chemical
Iron Oxide Red
Concentration
Proprietary
General Information
Revision date
2014-03-17
Product name
PROGESTERONE CAPSULE
Chemical name
For Active Ingredient Pregn-4-ene-3 20-dione For
1.2.2. Uses advised against
Other than Relevant Use HOW SUPPLIED 100 mg Peach Capsule NDC 0093-5353-01 100 in 1 bottle; 200 mg Pale Yellow Capsule NDC 0093-5354-01 100 in 1 bottle
Manufacturer Name
TEVA
Emergency telephone
1-800/424-9300, 01-703-527-3887
Icons in SDS
Company Information
company name
TEVA
e-mail address of the competent person responsible for the Safety Data Sheet
TevaSDSRequest@tevapharm.com
Section 2
SECTION 2: Hazards identification
Product definition
This product is supplied as odorless capsules which are peach (100 mg) and pale yellow (200 mg). Health Hazards In the workplace, exposure via inhalation and skin contact may cause irritation. Eye contact with drug product can cause mechanical irritation. In men, exposure to female hormones has been associated with testicular atrophy, increased risk of prostate cancer, gynecomastia, loss of libido and potency. As a progesterone-only hormone, this material is possibly carcinogenic in humans. In therapeutic, the most common adverse effects reported include, headaches, breast pain, irregular vaginal bleeding or spotting, stomach or abdominal cramps, nausea, vomiting, hair loss, fluid retention, vaginal yeast infections. Due to the Peanut Oil component, ingestion of this product by persons with peanut allergies may cause sensitization and allergic reactions; reactions have the potential to be severe. These effects may be possible as a result of workplace exposure. Refer to Section 11 (Toxicological Information) for additional information on adverse effects. Flammability Hazards: This product requires substantial pre- heating before ignition occurs. When involved in a fire, this product may decompose and produce irritating vapors and toxic compounds (including acrolein, carbon, iron, titanium and nitrogen oxides). Reactivity Hazards: This product is not reactive. Environmental Hazards: Release of this product to the environment may cause harm to aquatic or terrestrial organisms. Emergency Recommendations: Emergency responders must wear personal protective equipment suitable for the situation to which they are responding.