Label: SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER- sulfacetamide sodium and sulfur rinse

  • NDC Code(s): 42192-136-06, 42192-136-08, 42192-136-12
  • Packager: Acella Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 11, 2018

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  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION

    DESCRIPTION: Each mL of Sodium Sulfacetamide 10% - Sulfur 5% Cleanser contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur in a formulation containing butylated hydroxytoluene, cetyl alcohol, disodium EDTA, glyceryl stearate, 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.

    Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

    Chemical Structure
  • 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 not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

  • INDICATIONS & USAGE

    INDICATIONS: Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS: Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is not to be used by patients with kidney disease.

  • WARNINGS

    WARNINGS: Although rare, sensitivity to sodium sulfacetaminde 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.

  • SPL UNCLASSIFIED SECTION

    FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.

  • PRECAUTIONS:

    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.

    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 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 Sodium Sulfacetamide 10% - Sulfur 5% Cleanser. It is not known whether Sodium Sulfacetamide 10% - Sulfur 5% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% - Sulfur 5% Cleanser 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 the human milk following topical use of Sodium Sulfacetamide 10% - Sulfur 5% Cleanser. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 10% - Sulfur 5% Cleanser 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: Apply Sodium Sulfacetamide 10% - Sulfur 5% Cleanser once or twice daily to affected areas, or as directed by your physician. 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 Sodium Sulfacetamide 10% - Sulfur 5% Cleanser sooner or using less often.

  • HOW SUPPLIED

    HOW SUPPLIED: Sodium Sulfacetamide 10% - Sulfur 5% Topical Suspension is available in 6 oz (170.3 g) bottles, NDC 42192-136-06, 8 oz (227 g) bottles, 42192-136-08 and 12 oz (340.2 g) bottles, NDC 42192-136-12.

    Store at 15° - 25°C (59° - 77°F). Protect from freezing.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

    All prescription substitutions using this product shall be made subject to state and federal statutes as applicable.

    NOTE: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED FOR:
    Acella Pharmaceuticals, LLC
    Alpharetta, GA 30009 • 1-800-541-4802

    Rev. 0616-03

  • PRINCIPAL DISPLAY PANEL - 170.3 g Bottle Label

    NDC 42192-136-06

    Sodium Sulfacetamide 10% -
    Sulfur 5%
    Cleanser

    Rx Only

    SHAKE WELL BEFORE USE

    6 oz (170.3 g)

    Acella
    PHARMACEUTICALS, LLC

    PRINCIPAL DISPLAY PANEL - 170.3 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER 
    sulfacetamide sodium and sulfur rinse
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42192-136
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM10 mg  in 1 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    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)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42192-136-06170.3 g in 1 BOTTLE; Type 0: Not a Combination Product04/20/2012
    2NDC:42192-136-08227 g in 1 BOTTLE; Type 0: Not a Combination Product09/19/2016
    3NDC:42192-136-12340.2 g in 1 BOTTLE; Type 0: Not a Combination Product04/20/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/20/2012
    Labeler - Acella Pharmaceuticals, LLC (825380939)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acella Pharmaceuticals, LLC825380939manufacture(42192-136)