PROGESTERONE CAPSULE

TEVA

Revision date : 2014-03-17

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Health risk rating
Safety risk rating
Environmental risk rating

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.

SDS Library

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Safety – One-click access to first aid information.
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Labels – Generate Secondary Container Labels with just one click.