Label: BP CLEANSING WASH- sodium sulfacetamide and sulfur liquid
- NDC Code(s): 42192-103-16
- Packager: Acella Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated September 19, 2018
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DESCRIPTION: Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
Each mL of Sodium Sulfacetamide 10% and Sulfur 4% contains 100 mg of sodium sulfacetamide and 40 mg of sulfur in an emulsion base containing urea 10%, butylated hydroxytoluene, cetyl alcohol, disodium EDTA, disodium oleamido MEA sulfosuccinate, glyceryl stearate and PEG 100 stearate, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, white petrolatum 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 & USAGE
WARNINGS AND PRECAUTIONS
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. FOR EXTERNAL USE ONLY. Keep bottle tightly closed. Keep away from eyes. Keep out of reach of children.
PRECAUTIONS: If irritation develops, use of the product should be discontinued and appropriate therapy started. 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.
- INFORMATION FOR PATIENTS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
Pregnancy - Category C. Animal reproduction studies have not been conducted with BP Cleansing Wash. When administered to a pregnant woman, it also is not known whether BP Cleansing Wash can affect reproduction capacity or cause fetal harm. BP Cleansing Wash 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 topical use of BP Cleansing Wash. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised when BP Cleansing Wash is administered to a nursing woman.
- PEDIATRIC USE
- ADVERSE REACTIONS
DOSAGE & ADMINISTRATION
DOSAGE AND ADMINISTRATION: BP Cleansing Wash: Wash affected area once or twice daily or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10-20 seconds, working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off cleansing wash sooner or using less often.
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY - 473 mL bottle label
INGREDIENTS AND APPEARANCE
BP CLEANSING WASH
sodium sulfacetamide and sulfur liquid
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42192-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM 100 mg in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETYL ALCOHOL (UNII: 936JST6JCN) EDETATE DISODIUM (UNII: 7FLD91C86K) DISODIUM OLEAMIDO MEA-SULFOSUCCINATE (UNII: 5M1101WGSY) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) SODIUM THIOSULFATE (UNII: HX1032V43M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PETROLATUM (UNII: 4T6H12BN9U) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42192-103-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/23/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/23/2008 Labeler - Acella Pharmaceuticals, LLC (825380939) Establishment Name Address ID/FEI Business Operations Acella Pharmaceuticals, LLC 825380939 manufacture(42192-103)