Label: BP CLEANSING WASH- sodium sulfacetamide and sulfur liquid

  • NDC Code(s): 42192-103-16
  • Packager: Acella Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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.

Drug Label Information

Updated September 19, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • DESCRIPTION

    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:

    Chemical Structure

    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

    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

    INDICATIONS: BP Cleansing Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS: BP Cleansing Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. BP Cleansing Wash is not to be used by patients with kidney disease.

  • 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

    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

    Information for Patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.

  • CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

    Carcinogenesis, Mutagenesis and Impairment of Fertility - Long-term studies in animals have not been performed to evaluate carcinogenic potential.

  • PREGNANCY

    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

    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

    Pediatric Use - Safety and effectiveness in children under the age of 12 have not been established.

  • ADVERSE REACTIONS

    ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.

  • 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

    HOW SUPPLIED: BP Cleansing Wash is available in a 16 fl. oz. (473 mL) bottle, NDC 42192-103-16. Store BP Cleansing Wash at controlled room temperature 15°-30° C (59°-86° F). Protect from freezing.

  • SPL UNCLASSIFIED SECTION

    KEEP OUT OF REACH OF CHILDREN.

    MANUFACTURED FOR: Acella Pharmaceuticals, LLC
    Alpharetta, GA 30009
    1-800-541-4802
    Rev. 1209

  • PACKAGE LABEL.PRINCIPAL DISPLAY - 473 mL bottle label

    NDC 42192-103-16

    R x Only BP
    Cleansing
    Wash

    (Sodium Sulfacetamide 10%
    and Sulfur 4%)

    In a Urea Vehicle

    For Topical Use Only

    Acella
    PHARMACEUTICALS, LLC

    16 fl. oz. (473 mL)

    label

  • INGREDIENTS AND APPEARANCE
    BP CLEANSING WASH 
    sodium sulfacetamide and sulfur liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42192-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM100 mg  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42192-103-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/23/2008
    Labeler - Acella Pharmaceuticals, LLC (825380939)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acella Pharmaceuticals, LLC825380939manufacture(42192-103)