Label: SODIUM SULFACETAMIDE - SULFUR CLEANSING PADS- sodium sulfacetamide, sulfur swab

  • NDC Code(s): 42192-113-60
  • Packager: Acella Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 12, 2018

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  • DESCRIPTION

    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:


    productformula

    Each pad of Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are coated with a cleanser-based formulation. Each gram of this cleanser-based
    formulation contains 100 mg of Sodium Sulfacetamide and 40 mg of Sulfur. The cleanser base consists of: purified water, sodium cocoyl isethionate
    disodium oleamido MEA sulfosuccinate, green tea extract, cetyl alcohol, stearyl alcohol, glycerol stearate and PEG 100 stearate methyl paraben, propyl
    paraben, butylated hydroxytoluene, aloe vera gel, sodium thiosulfate, disodium EDTA, magnesium aluminum silicate, xanthan gum, sodium methyl cocoyl
    taurate, white petrolatum.

  • 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 4% Cleansing Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS: Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are contraindicated for use by patients having known hypersensitivity
    to sulfonamides, sulfur or ony other component of this preparation. Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are 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.
    FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.

  • PRECAUTIONS

    PRECAUTIONS: General - If irritaition 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 desqamation withour
    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 vulfaris, 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.

  • PREGNANCY

    PREGNANCY: Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% - Sulfur 4% Cleansing
    Pads. It is not known whether Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads can cause fetal harm when administered to a pregnant woman or
    can affect reproduction capacity. Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads 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 4% Cleansing Pads. 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 4% Cleansing Pads are
    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: Wash affected area(s) with cleansing pad once or twice dialy, or as directed by your physician. Wet area(s) with
    water. Wet pad with a little water and work into a full lather. Cleanse area(s) with pad for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry.
    Discard pad. Do not flush.

  • HOW SUPPLIED

    HOW SUPPLIED: Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are available in boxes of 60 cloths (3.7 g), (NDC 42192-113-60).
    Store at controlled room temperature, 15° - 25° (59° - 77°F).
    All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book
    product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. 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, incipients, inactive ingredients and chemical formulation information provided herein.

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED FOR: Acella Pharmaceuticals, LLC
    9005 Westside Parkway
    Alpharetta, GA 30009
    1-800-541-4802

  • PRINCIPAL DISPLAY PANEL

    Sodum Sulfacetamide 10%-

    Sulfur 4% Cleansing Pads

    In a vehicle containing Green Tea and Aloe
    Rx Only
    60 cleansing pads
    Net wegith 3.7g each
    Acella pharmaceuticals

    Directions: Wash affected areas with Sodium Sulfacetamide 10% - Sulfur 4% once or twice daily or as direted by your physician.
    1. Wet affected areas with water
    2. Wet Sodium Sulfacetamide 10% - Sulfur 4% cleansing pad with water and work into a full lather.
    3. Cleanse face with Sodium Sulfacetamide 10% - Sulfur 4% for 10 -20 seconds, avoiding eyes
    4. Rinse thoroughly and pat dry
    5. Discard pad. Do not flush.

    Warnings for external use only. Keep out of reach of children. Avoid contact with eyes.

    Indications: for the typical control of acne vulgaris and seborrheic dermatitis. See package insert for full prescribing information.

    Contraindications: Sodium Sulfacetamide 10% - Sulfur 4% cleansing pads are contraindicated for use in patients having known hypersensitivity to sulfonamides, sulfur or anyother component of the preparation. Sodium Sulfacetamide 10% - Sulfur 4% cleansing pads are not to be used by patients with kidney disease.

    Contents: Sodium Sulfacetamide 10% - Sulfur 4%. Other Ingredients: purified water, sodium cocoyl isethionate, disodium oleamido MEA sulfosuccinate, green tea extract, cetyl alcohol, stearyl alcohol, glycerol stearate and PEG 100 stearate methyl paraben, propyl paraben, butylated hydroxytoluene, aloe vera gel, sodium thiosufate, disodium EDTA, magnesium aluminum siliate, xanthan gum, sodium methyl cocoyl l-taurate, white petrolatum

    Acella Pharmaceuticals

    Store at 15 degrees to 25 degrees C or 59-77 degrees F)

    All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE. This is not an Orange Book product. No representation is made as to generic status or bioequivalency. Please see package insert for more information.

    Manufactured For:
    Acella Pharmaceuticals, LLC
    9005 Westside Parkway
    Alpharetta, GA 30009
    1-800-541-4802

  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

    outerlabel

  • INGREDIENTS AND APPEARANCE
    SODIUM SULFACETAMIDE - SULFUR CLEANSING PADS 
    sodium sulfacetamide, sulfur swab
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42192-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM10 g  in 100 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM THIOSULFATE (UNII: HX1032V43M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42192-113-6060 in 1 BOX07/30/2009
    13.7 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/30/2009
    Labeler - Acella Pharmaceuticals, LLC (825380939)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acella Pharmaceuticals, LLC825380939manufacture(42192-113)