Label: SUMADAN WASH- sulfacetamide sodium and sulfur cream
SUMADAN- sulfacetamide sodium and sulfur kit

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 16, 2020

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  • SPL UNCLASSIFIED SECTION

    Rx Only

    In a Moisturizing
    Novasome® Vehicle

  • DESCRIPTION

    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

    Each mL of Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation consisting of: butylated hydroxytoluene, C12-15 alkyl benzoate, caprylyl glycol, cetyl alcohol, cholesterol, chrysanthemum dendranthema, dimethicone, disodium oleamido MIPA sulfosuccinate, edetate disodium, ethylene brassilate, glyceryl stearate, hexylene glycol, lemon oil, magnesium aluminum silicate, magnesium chloride, magnesium nitrate, methylchloroisothiazolinone, methylisothiazolinone, niacinamide, nonoxynol-20, octoxynol-5, purified water, PEG-100 stearate, phenoxyethanol, propylene glycol, sodium cocoyl isotheionite, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, 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

    Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

  • CONTRAINDICATIONS

    Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash 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.

    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 Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash. It is also not known whether Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash should be given to a pregnant woman only if clearly needed.

    NURSING MOTHERS

    It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash. 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 Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is administered to a nursing woman.

    PEDIATRIC USE

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

  • ADVERSE REACTIONS:

    Although rare, sodium sulfacetamide may cause local irritation.

  • DOSAGE AND ADMINISTRATION

    Apply Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash 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 Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash sooner or using less often.

  • HOW SUPPLIED

    Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is available in a Net wt. 16 oz. (454 g) bottle, NDC 43538-190-16.

    Sumadan® KIT contents one unit of Sumadan® Wash, Net wt. 16 oz. (454 g) and one unit of Rehyla® Wash, 16 oz. bottle, NDC 43538-191-16.

    Store at controlled room temperature 15°- 30° C (59°- 86° F). Protect from freezing.

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

    To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc., at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    MEDIMETRIKS
    PHARMACEUTICALS, INC.

    383 Route 46 West
    Fairfield, NJ 07004-2402 USA

    www.medimetriks.com

    IP022-R4
    Rev. 08/20

  • PRINCIPAL DISPLAY PANEL - 454 g Bottle Carton

    NDC 43538-190-16

    Rx Only
    Sumadan®
    (Sodium Sulfacetamide 9% & Sulfur 4.5%)
    WASH
    In a moisturizing
    Novasome® vehicle

    Net Wt. 16 oz. (454 g)

    MEDIMETRIKS
    PHARMACEUTICALS, INC.

    PRINCIPAL DISPLAY PANEL - 454 g Bottle Carton
  • PRINCIPAL DISPLAY PANEL - Kit Carton

    NDC 43538-191-16

    Rx Only
    Sumadan®
    (Sodium Sulfacetamide 9% & Sulfur 4.5%)
    KIT

    CONTENTS:
    1 - Sumadan® (Sodium Sulfacetamide 9% & Sulfur 4.5%) Wash (Net Wt. 16 oz.)
    1- Rehyla® Wash Moisturizing Daily Wash (16 fl. oz.)

    MEDIMETRIKS
    PHARMACEUTICALS, INC.

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    SUMADAN WASH 
    sulfacetamide sodium and sulfur cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43538-190
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    sulfacetamide sodium (UNII: 4NRT660KJQ) (sulfacetamide - UNII:4965G3J0F5) sulfacetamide sodium90 mg  in 1 g
    sulfur (UNII: 70FD1KFU70) (sulfur - UNII:70FD1KFU70) sulfur45 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    caprylyl glycol (UNII: 00YIU5438U)  
    cetyl alcohol (UNII: 936JST6JCN)  
    cholesterol (UNII: 97C5T2UQ7J)  
    dimethicone (UNII: 92RU3N3Y1O)  
    edetate disodium (UNII: 7FLD91C86K)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    hexylene glycol (UNII: KEH0A3F75J)  
    lemon oil (UNII: I9GRO824LL)  
    magnesium aluminum silicate (UNII: 6M3P64V0NC)  
    magnesium chloride (UNII: 02F3473H9O)  
    magnesium nitrate (UNII: 77CBG3UN78)  
    methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    methylisothiazolinone (UNII: 229D0E1QFA)  
    niacinamide (UNII: 25X51I8RD4)  
    nonoxynol-20 (UNII: 60ZT1XYO5N)  
    octoxynol-5 (UNII: TJ327E1R1V)  
    water (UNII: 059QF0KO0R)  
    PEG-100 stearate (UNII: YD01N1999R)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    sodium methyl cocoyl taurate (UNII: JVL98CG53G)  
    sodium thiosulfate (UNII: HX1032V43M)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43538-190-161 in 1 CARTON07/10/2011
    1454 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER07/10/2011
    SUMADAN 
    sulfacetamide sodium and sulfur kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43538-191
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43538-191-161 in 1 CARTON; Type 0: Not a Combination Product08/01/2011
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PUMP 454 g
    Part 21 BOTTLE, PUMP 454 g
    Part 1 of 2
    SUMADAN WASH 
    sulfacetamide sodium and sulfur cream
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sulfacetamide Sodium (UNII: 4NRT660KJQ) (Sulfacetamide - UNII:4965G3J0F5) Sulfacetamide Sodium90 mg  in 1 g
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur45 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    caprylyl glycol (UNII: 00YIU5438U)  
    cetyl alcohol (UNII: 936JST6JCN)  
    cholesterol (UNII: 97C5T2UQ7J)  
    dimethicone (UNII: 92RU3N3Y1O)  
    disodium oleamido mipa-sulfosuccinate (UNII: 0MBZ20845F)  
    edetate disodium (UNII: 7FLD91C86K)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    hexylene glycol (UNII: KEH0A3F75J)  
    lemon oil (UNII: I9GRO824LL)  
    magnesium aluminum silicate (UNII: 6M3P64V0NC)  
    magnesium chloride (UNII: 02F3473H9O)  
    magnesium nitrate (UNII: 77CBG3UN78)  
    methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    methylisothiazolinone (UNII: 229D0E1QFA)  
    niacinamide (UNII: 25X51I8RD4)  
    nonoxynol-20 (UNII: 60ZT1XYO5N)  
    octoxynol-5 (UNII: TJ327E1R1V)  
    water (UNII: 059QF0KO0R)  
    PEG-100 stearate (UNII: YD01N1999R)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    sodium methyl cocoyl taurate (UNII: JVL98CG53G)  
    sodium thiosulfate (UNII: HX1032V43M)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    xanthan gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    1454 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other06/01/2011
    Part 2 of 2
    REHYLA WASH 
    moisturizing cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRwater (UNII: 059QF0KO0R)  
    INGRglyceryl monostearate (UNII: 230OU9XXE4)  
    INGRglycerin (UNII: PDC6A3C0OX)  
    INGRcetyl alcohol (UNII: 936JST6JCN)  
    INGRdisodium oleamido mipa-sulfosuccinate (UNII: 0MBZ20845F)  
    INGRcholesterol (UNII: 97C5T2UQ7J)  
    INGRdisodium laureth sulfosuccinate (UNII: D6DH1DTN7E)  
    INGRhelianthus annuus seed wax (UNII: 42DG15CHXV)  
    INGRcaprylyl glycol (UNII: 00YIU5438U)  
    INGRpropylene glycol (UNII: 6DC9Q167V3)  
    INGRphenoxyethanol (UNII: HIE492ZZ3T)  
    INGRsodium cocoyl isethionate (UNII: 518XTE8493)  
    INGRcocamidopropyl betaine (UNII: 5OCF3O11KX)  
    INGRsodium methyl cocoyl taurate (UNII: JVL98CG53G)  
    INGRC13-14 isoparaffin (UNII: E4F12ROE70)  
    INGRsodium chloride (UNII: 451W47IQ8X)  
    INGRniacinamide (UNII: 25X51I8RD4)  
    INGRedetate disodium (UNII: 7FLD91C86K)  
    INGRhexylene glycol (UNII: KEH0A3F75J)  
    INGRlaureth-7 (UNII: Z95S6G8201)  
    INGRchamaemelum nobile flower (UNII: O2T154T6OG)  
    INGRhyaluronate sodium (UNII: YSE9PPT4TH)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    1454 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic08/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other08/01/2011
    Labeler - Medimetriks Pharmaceuticals Inc. (019903816)
    Establishment
    NameAddressID/FEIBusiness Operations
    IGI Laboratories011036910MANUFACTURE(43538-190, 43538-191)
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