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

  • NDC Code(s): 58980-340-61, 58980-340-85
  • Packager: Stratus Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 04/12

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  • SPL UNCLASSIFIED SECTION

    Rx only

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  • DESCRIPTION

    Each gram of SODIUM SULFACETAMIDE 10% and SULFUR 5% CLEANSER contains ACTIVES: sodium sulfacetamide 10% (100mg) and sulfur 5% (50 mg) in a cleanser base of INACTIVES: butylated hydroxytoluene, disodium EDTA, disodium laureth sulfosuccinate and disodium lauryl sulfoacetate, emulsifying wax, hydrochloric acid, methyl paraben, mineral oil, PPG-hydroxyethyl coco isostearamide, propyl paraben, purified water, sodium cocoyl isethionate and sodium thiosulfate

    Sodium Sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically, Sodium Sulfacetamide is N-{(4-aminophenyl)sulfony}-acetamide, monosodium salt, monohydrate.

    The structural formula is:

    Chemical Structure
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  • CLINICAL PHARMACOLOGY

    The most widely accepted mechanism of action of sulfonamides in 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.

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  • INDICATIONS AND USAGE

    SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

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  • CONTRAINDICATIONS

    SODIUM SULFACETAMIDE 10% AND 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% AND SULFUR 5% CLEANSER is not to be used by patients with kidney disease.

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  • 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 out of reach of children. Keep bottle tightly closed.

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  • PRECAUTIONS

    General

    If irritation develops, use of this product should be discontinued and appropriate therapy instituted. Patients should be very carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy i s 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.

    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% AND SULFUR 5% CLEANSER. It is also not known whether SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER 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 SODIUM SULFACETAMIDE 10% AND 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% AND SULFUR 5% CLEANSER is administered to a nursing woman.

    Pediatric Use

    Safety and effectiveness in children under the age of 12 has not been established.

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  • ADVERSE REACTIONS

    Although rare, sodium sulfacetamide may cause local irritation.

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  • DOSAGE AND ADMINISTRATION

    Wash affected areas 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 treated, 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 wash off sooner or using less often.

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  • HOW SUPPLIED

    SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER is available in:

     
    6 oz. (170.3g) bottles - NDC 58980-340-61
     
    12 oz. (340.2g) bottles - NDC 58980-340-85

    STORAGE

    Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F), however such exposure should be minimized. Protect from freezing.

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  • SPL UNCLASSIFIED SECTION

    Distributed by
    STRATUS

    PHARMACEUTICALS INC

    Manufactured by
    Sonar Products, Inc.
    Carlstadt, NJ 07072
    for
    Stratus Pharmaceuticals Inc.
    12379 Southwest 130th Street
    Miami, Florida 33186-6727

    Customer Service
    Telephone: 1-800-442-7882
    Fax: 305-254-6875

    ©2011 Stratus Pharmaceuticals Inc.

    Rev. SSSC-IN2011-343.

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  • PRINCIPAL DISPLAY PANEL - 170.3 g Bottle Label

    NDC 58980-340-61

    FOR EXTERNAL USE ONLY

    SODIUM
    SULFACETAMIDE 10%
    & SULFUR 5%
    CLEANSER

    Rx only

    STRATUS
    PHARMACEUTICALS INC

    Net WT. 6 OZ (170.3 g)

    PRINCIPAL DISPLAY PANEL - 170.3 g Bottle Label
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  • INGREDIENTS AND APPEARANCE
    SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER 
    sulfacetamide sodium and sulfur rinse
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-340
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sulfacetamide Sodium (Sulfacetamide) Sulfacetamide Sodium 10 mg  in 1 g
    Sulfur (Sulfur) Sulfur 5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Butylated Hydroxytoluene  
    Edetate Disodium  
    Disodium Laureth Sulfosuccinate  
    Sodium Lauryl Sulfoacetate  
    Hydrochloric Acid  
    Methylparaben  
    Mineral Oil  
    Propylparaben  
    Sodium Cocoyl Isethionate  
    Sodium Thiosulfate  
    Product Characteristics
    Color YELLOW Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58980-340-85 1 in 1 BOX
    1 340.2 g in 1 BOTTLE
    2 NDC:58980-340-61 1 in 1 BOX
    2 170.3 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 04/30/2012
    Labeler - Stratus Pharmaceuticals (789001641)
    Registrant - Sonar Products, Inc (104283945)
    Establishment
    Name Address ID/FEI Business Operations
    Sonar Products, Inc 104283945 MANUFACTURE(58980-340)
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