FDA Label for Sodium Sulfacetamide
View Indications, Usage & Precautions
Sodium Sulfacetamide Product Label
The following document was submitted to the FDA by the labeler of this product Exact-rx, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Description
DESCRIPTION: Each gram contains 100 mg of sodium sulfacetamide USP in a vehicle consisting of: cocamidopropyl betaine, disodium EDTA, methyl paraben, PEG-60 almond triglyceride, PEG-6 caprylic/capric glycerides, PEG-150 pentaerythrityl tetrastearate, purified water, sodium laureth sulfate, and sodium thiosulfate.
Chemically, it is Acetamide N-[4-aminophenyl)sulfonyl]-, monosodium salt, monohydrate, with the following structural formula:
Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform, and in ether.
Clinical Pharmacology
CLINICAL PHARMACOLOGY: Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There are no clinical data available on the degree and rate of systemic competition with para-aminobenzoic acid absorption of Sodium Sulfacetamide 10% Wash when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported. The following in vitro data are available but their clinical significance is unknown. Organisms which show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.
Indications & Usage
INDICATIONS AND USAGE: Sodium Sulfacetamide 10% Wash is intended for topical application in the following scaling dematoses: seborrheic dermatitis and sebonthea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.
Contraindications
CONTRAINDICATIONS: Sodium Sulfacetamide 10% Wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.
Warnings
WARNINGS: Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically.
Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. Keep out of the reach of children.
Precautions
PRECAUTIONS: For external use only. Not for ophthalmic use. General: Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration, and cross hypersensitivity between different sulfonamides may occur. If Sodium Sulfacetamide 10% Wash produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded, or severely burned areas. Under these circumstances, potentially any of the adverse effects produced by the systemic administration of these agents could occur and appropriate observations and laboratory determinations should be performed.
Storage And Handling
STORAGE: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing.
Note: Store upright. Protect from freezing and excessive heat. The wash may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product.
Occasionally, a slight yellowish discoloration may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration is readily removed by ordinary laundering without bleaches.
Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747
00-0100-99-205-00
Iss:5/11
Package Label - 12 Oz (354.8 Ml)
For External Use Only
NDC 42808-0100-06 Rx Only
Sodium
Sulfacetamide
10%
WASH
Exact-Rx.
INCORPORATED
Net Wt. 12 oz (354.8 ml)
* Please review the disclaimer below.