SODIUM SULFACETAMIDE AND SULFUR EXTERNAL LIQUID- sulfacetamide sodium and sulfur liquid
Cameron Pharmaceuticals, LLC
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.
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Sulfacetamide Sodium-Sulfur 10-2% External Liquid
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 Liquid contains 100 mg of sulfacetamide sodium and 20 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, phenoxyethanol, propylene glycol, purified water, sodium lauryl sulfate, sodium magnesium silicate, sodium thiosulfate, stearyl alcohol and xanthan gum.
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.
INDICATIONS
Sulfacetamide Sodium-Sulfur 10-2% External Liquid is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS
Sulfacetamide Sodium-Sulfur 10-2% External Liquid 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.
WARNINGS
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.
PRECAUTIONS:
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
General
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 Liquid. It is also not known whether Sulfacetamide Sodium-Sulfur 10-2% External Liquid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide Sodium-Sulfur 10-2% External Liquid should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether sodium sulfacetamide is excreted in human milk following topicaI use of Sulfacetamide Sodium-Sulfur 10-2% External Liquid. 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 Liquid is administered to a nursing woman.
ADVERSE REACTIONS
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..
DOSAGE AND ADMINISTRATION
Wash affected areas with Sulfacetamide Sodium-Sulfur 10-2% External Liquid 1 to 2 times daily or as directed by a licensed medical practitioner. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10 to 20 seconds working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing cleanser off sooner or using cleanser less often.
HOW SUPPLIED
Sulfacetamide Sodium-Sulfur 10-2% External Liquid is supplied in an 8 oz. (227 g) bottle, NDC 42494-334-08.
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
Rx Only
Manufactured for:
Cameron Pharmaceuticals, LLC
1009 Twilight Trail
Frankfort, Kentucky 40601
Rev. 2/2015
| SODIUM SULFACETAMIDE AND SULFUR EXTERNAL LIQUID
sulfacetamide sodium and sulfur liquid |
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| Labeler - Cameron Pharmaceuticals, LLC (078371442) |
| Registrant - Cameron Pharmaceuticals, LLC (078371442) |