LIDOCAINE TOPICAL 5% PATCH

ACTAVIS, INC

Revision date : 2015-08-03

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Health risk rating
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Note: Ingredients listed on restricted chemical lists

EC/CAS

205-302-8/137-58-6

Name of the chemical

Lidocaine (INN)

Concentration

5.0%

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

310-194-1/1332-58-7

Name of the chemical

kaolin

Concentration

Proprietary

EC/CAS

202-785-7/99-76-3

Name of the chemical

4-hydroxybenzoic acid, methyl ester

Concentration

Proprietary

EC/CAS

200-338-0/57-55-6

Name of the chemical

1,2-propanediol

Concentration

Proprietary

EC/CAS

202-307-7/94-13-3

Name of the chemical

Propylparaben; propyl 4-hydroxybenzoate

Concentration

Proprietary

EC/CAS

200-061-5/50-70-4

Name of the chemical

D-glucitol C6H14O6

Concentration

Proprietary

EC/CAS

201-766-0/87-69-4

Name of the chemical

L-(+)-tartaric acid

Concentration

Proprietary

EC/CAS

200-315-5/57-13-6

Name of the chemical

urea

Concentration

Proprietary

EC/CAS

231-791-2/7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

Proprietary

General Information

Revision date

2015-08-03

Product name

LIDOCAINE TOPICAL 5% PATCH

Product Synonyms

FORMULA (for active ingredient): C14H22N2O

Chemical name

For

1.2.2. Uses advised against

Non-Pharmaceutical Use

supplier name

U.S

Emergency telephone

1-800-424-9300, +1-703-527-3887

Icons in SDS

Company Information

company name

ACTAVIS, INC

e-mail address of the competent person responsible for the Safety Data Sheet

SDS@Actavis.com

Section 2

SECTION 2: Hazards identification

Product definition

This product consists is comprised of an adhesive material containing 5% Lidocaine in an aqueous base, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner, and is packaged in a foil-backed pouch.

Health hazards

The chief health hazard associated with exposure during normal use and handling is the potential for irritation of contaminated skin. Prolonged skin contact may cause symptoms of therapeutic use. In therapeutic use, the most common adverse effects reported are mild irritation, redness, or swelling where the medication is applied; or numbness in places patch is supplied. Adverse effects on the central nervous and cardiovascular system have been reported. Persons who are allergic to amide-type local anesthetics such as Lidocaine, may experience allergic reactions to this product. Severe allergic reactions can occur and can include anaphylactic reactions and shock. More information on adverse effects from therapeutic use is described in Section 11 (Toxicological Information). Reactivity Hazards: This product is not reactive. Flammability Hazards: This product may be combustible and may ignite if involved in a fire and the water evaporates. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon and nitrogen oxides, acrolein).

Environmental hazards

Large quantities released to the aquatic and terrestrial environment may have an adverse effect. Emergency Considerations: Emergency responders should wear appropriate protection for situation to which they respond.

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