Dibucaine Ointment USP, 1.0%

FOUGERA PHARMACEUTICALS INC

Revision date : 2015-09-06

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Health risk rating
Safety risk rating
Environmental risk rating

Note: Ingredients listed on restricted chemical lists

EC/CAS

201-632-1/85-79-0

Name of the chemical

Cinchocaine (INN) and its salts

Concentration

1.0%

EC/CAS

231-791-2/7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

Proprietary

EC/CAS

232-373-2/8009-03-8

Name of the chemical

Petrolatum

Concentration

Proprietary

Listed in

General Information

Revision date

2015-09-06

Product name

Dibucaine Ointment USP, 1.0%

Chemical name

for active ingredient

1.2.1 Relevant identified uses

Pharmaceutical for Human Use

Emergency telephone

1(813) 676-1670

Icons in SDS

Company Information

company name

FOUGERA PHARMACEUTICALS INC

Section 2

SECTION 2: Hazards identification

1272/2008 GLOBAL HARMONIZATION AND EU CLP REGULATION (EC)

Product definition

This product is a pale yellow ointment with a mild petroleum jelly and lanolin odor. Health Hazards: Prolonged skin contact may cause irritation. Ingestion may be harmful. Inhalation is unlikely due to viscous product form. Contact with eyes may cause temporary blurring of vision and irritation. The active ingredient is toxic by subcutaneous route of exposure. The active ingredient is a photosensitizing agent which can cause skin reactions in persons who have UV exposure doing use. Although rare, the Lanolin component may cause skin sensitization and allergic reaction in susceptible individuals. Due to presence of sulfite compound, persons susceptible to sulfites may experience severe anaphylaxis or other asthmatic reactions to this product. In therapeutic use, the most common adverse effects reported have included rash and irritation. Refer to Section 11 (Toxicological Information) for

Additional information

on possible effects from therapeutic use. Under certain conditions, skin contact may cause adverse systemic effects (refer to Section 11 for additional information on possible effects). Flammability Hazards: This product must be substantially heated for ignition to become a hazard. When involved in an intense fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon, sodium, sulfur and nitrogen oxides). Reactivity Hazards This product is not reactive.

Environmental hazards

This product has not been tested for

Environmental effects

however, all release to the environment should be avoided. Emergency Considerations Emergency responders should wear appropriate protection for situation to which they respond.

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