Sulfacetamide Sodium Ophthalmic Solution USP, 10%

BAUSCH & LOMB PHARMACEUTICALS, INC

Revision date : 2002-01-25

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Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

General Information

Revision date

2002-01-25

Product name

Sulfacetamide Sodium Ophthalmic Solution USP, 10%

Product Synonyms

Same

CAS No.

6209-17-2

1.2.1 Relevant identified uses

for dispensing, and overpacked inside a cardboard carton

Emergency telephone

(800) 227-1427

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Company Information

company name

BAUSCH & LOMB PHARMACEUTICALS, INC

Section 2

SECTION 2: Hazards identification

EMERGENCY OVERVIEW Plastic bottle in a cardboard box. Clear, colorless solution. *************************************************************************************************

Health hazards

Carcinogenicity: (NTP) No (IARC) No (OSHA) No Eye: May cause irritation, stinging and burning. While the irritation may be transient, occasionally the treatment must be discontinued. Can cause hypersensitivity (anaphylactic) in some individuals. Skin: May cause irritation and hypersensitivity in some individuals. Hypersensitivity reactions include headache, rash, hives (urticaria), photosensitivity and central nervous system effects. Ingestion: May cause irritation and hypersensitivity (anaphylactic) in some individuals. Hypersensitivity reactions include headache, rash, hives (urticaria), photosensitivity and central nervous system effects. Inhalation: May cause irritation and hypersensitivity in some individuals. Inhalation of a liquid preparation is not likely. Evaporation of this preparation is minimal.

Potential chronic health

Ophthalmic ointments may retard corneal healing. Non-susceptible organisms, including fungi, may proliferate with the use of these preparations. Sulfonamides are inactivated by the para-aminobenzoic acid present in purulent exudates. Sensitization may occur when a sulfonamide is re-administered irrespective of the route of administration, and cross reactivity between sulfonamides. Target Organs: Eyes, skin and central nervous system.

Medical Conditions Generally Aggravated by Exposure

Hypersensitivity to any of the components of the product. If the patient is sensitive to one sulfonamide they may be sensitive to sulfacetamide sodium. An isolated case of Stevens-Johnson syndrome was reported in a patient who had experienced a previous drug reaction to an orally administered sulfonamide. Also a single instance of local hypersensitivity was reported, which progressed to a fatal syndrome, resembling systemic lupus erythematosus.

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