Sodium Sulfacetamide and Sulfur Cream
Dosage Form: cream
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Sodium Sulfacetamide and Sulfur Cream Description
Sulfacetamide sodium is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
Each gram of Sulfacetamide Sodium-Sulfur 10-2% External Cream contains 100 mg of sulfacetamide sodium and 20 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum.
Sodium Sulfacetamide and Sulfur Cream - Clinical Pharmacology
The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours.
The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.
Sulfacetamide Sodium-Sulfur 10-2% External Cream is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Sulfacetamide Sodium-Sulfur 10-2% External Cream is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sulfacetamide Sodium-Sulfur 10-2% External Liquid is not to be used by patients with kidney disease.
Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.
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 REACH OF CHILDREN.
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.
Avoid contact with eyes or mucous membranes.
Carcinogenesis, Mutagenesis and Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Pregnancy: Category C.
Animal reproduction studies have not been conducted with Sulfacetamide Sodium-Sulfur 10-2% External Cream It is also not known whether Sulfacetamide Sodium-Sulfur 10-2% External Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide Sodium-Sulfur 10-2% External Cream should be given to a pregnant woman only if clearly needed.
It is not known whether sodium sulfacetamide is excreted in human milk following topicaI use of Sulfacetamide Sodium-Sulfur 10-2% External Cream However, small amounts of orally administered sulfonamides have been reported to be excreted in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sulfacetamide Sodium-Sulfur 10-2% External Cream is administered to a nursing woman.
Safety and effectiveness in children under the age of 12 has not been established.
Although rare, sodium sulfacetamide may cause local irritation. Call your licensed medical practitioner for medical advice about side effects. To report a serious adverse event, call 1-888-767-7913..
Sodium Sulfacetamide and Sulfur Cream Dosage and Administration
Wash hands. Cleanse affected area. Apply a thin layer 1 to 3 times daily or as directed by a licensed medical practitioner. Massage the cream completely and uniformly into the skin. Avoid contact with eyes or mucous membranes.
How is Sodium Sulfacetamide and Sulfur Cream Supplied
Sulfacetamide Sodium-Sulfur 10-2% External Cream is supplied in an 2 oz (57 g) bottle, NDC 42494-333-02.
Store at controlled room temperature 20°C - 25°C (68°F -77°F); excursions permitted to between 15°C to 30°C (59°F to 86°F).
Protect from freezing and excessive heat. Keep container tightly closed.
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product has not been evaluated for therapeutic equivalence.
KEEP OUT OF REACH OF CHILDREN
Cameron Pharmaceuticals, LLC
Frankfort, Kentucky 40601
PRINCIPAL DISPLAY PANEL - 57 g Bottle Label
WARNINGS: FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Net Wt. 2 oz (57 g)
|SODIUM SULFACETAMIDE AND SULFUR EXTERNAL CREAM
sulfacetamide sodium and sulfur cream
|Labeler - Cameron Pharmaceuticals, LLC (078371442)|
|Registrant - Cameron Pharmaceuticals, LLC (078371442)|
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