Label: EXACT-RX SODIUM SULFACETAMIDE AND SULFER 10%/5% CLEANSER- sodium sulfacetamide, sulfur lotion

  • NDC Code(s): 42808-113-06, 42808-113-12
  • Packager: Exact-Rx, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated July 8, 2021

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  • INDICATIONS & USAGE

    INDICATIONS: Sodium Sulfacetemide 10% and Sulfer 5% Cleanser

    is indicated for he topical control of acne vulgaris, acne rosacea and

    seborrheic dermatitis.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS FOR USE: Wash affected area once or twice daily, or

    as directed by your physician. Avoid contat 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

    cleanser off sooner or using less often. See package insert for complete product information.

  • WARNINGS

    FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR

    OPHTHALMIC USE. (KEEP AWAY FROM EYES).

  • WARNINGS

    KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.

    In case of accidental ingestion contact a poison

    control center immediately. Keep container tightly closed.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS: Sodium Sulfacetamide 10% & Sulfer 5% Cleanser is

    contraindicated in persons with know or suspected hypersensitivity to sulfonamides,

    sulfer or any other component of this preparation. Sodium Sulfacetamide 10% & Sulfer %5%

    Cleanser is not to be used by patients with kidney disease.

    CAUTION: If redness or irritaiton occurs, discontinue use.

  • INACTIVE INGREDIENT


    Each gram of sodium sulfacetamide 10% and sulfur 5% cleanser contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a cleanser containing ammonium lauryl sulfate, butylated hydroxytoluene, cetyl alcohol, cocamidopropyl betaine, disodium EDTA, glycerin, glyceryl stearate SE, guar gum, methylparaben, PEG-100 stearate, propylene glycol, propylparaben, purified water, sodium thiosulfate, stearyl alcohol, triacetin.

  • STORAGE AND HANDLING

    Store at 20 to 25C (68 to 77F). See USP Controlled Room Temperature. Protect from freezing.

    See bottle for lot number and expiration date

  • DESCRIPTION

    Manufactured in the U.S.A. for

    Exact-Rx, Inc., Melville, NY 11747

  • PATIENT PACKAGE INSERT

    Sodium Sulfacetamide 10% &
    Sulfur 5% Cleanser
    Rx Only
    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:
    Each gram of sodium sulfacetamide 10% and sulfur 5% cleanser
    contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a
    cleanser containing butylated hydroxytoluene, cetyl alcohol, disodium
    EDTA, disodium oleamido MEA-sulfosuccinate, glyceryl stearate,
    magnesium aluminum silicate, methylparaben, PEG-100 stearate,
    petrolatum, propylene glycol, propylparaben, purified water, sodium
    cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate,
    stearyl alcohol, xanthan gum.
    CLINICAL PHARMACOLOGY: The most widely accepted mechanism of
    action of sulfonamides is the Woods-Fields 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: Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is
    indicated in the topical control of acne vulgaris, acne rosacea and
    seborrheic dermatitis.
    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: Although it is 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.
    In case of accidental ingestion contact a poison control center
    immediately. 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
    also 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: 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 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: Safety and effectiveness in children under the age of 12
    have not been established.
    ADVERSE REACTIONS: Although rare, sodium sulfacetamide may
    cause local irritation.
    Call your doctor for medical advice about side effects.
    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
    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 cleanser off sooner or using less often.
    HOW SUPPLIED: Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is
    available in a 6 oz (170 g) bottle, NDC 42808-113-06 and a 12 oz (340
    g) bottle, NDC 42808-113-12.
    Store at 20 to 25°C (68 to 77°F). See USP Controlled Room Temperature.
    Protect from freezing.
    Manufactured in the U.S.A. for
    Exact-Rx, Inc., Melville, NY 11747
    00-113-205-00
    Iss:01

  • PRINCIPAL DISPLAY PANEL

    113-12

  • PRINCIPAL DISPLAY PANEL

    113-16

  • INGREDIENTS AND APPEARANCE
    EXACT-RX SODIUM SULFACETAMIDE AND SULFER 10%/5% CLEANSER 
    sodium sulfacetamide, sulfur lotion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42808-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR50 mg  in 1 g
    SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    GUAR GUM (UNII: E89I1637KE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM THIOSULFATE (UNII: HX1032V43M)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TRIACETIN (UNII: XHX3C3X673)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42808-113-06170 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2011
    2NDC:42808-113-12340 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2011
    Labeler - Exact-Rx, Inc. (137953498)