Label: SULFACETAMIDE SODIUM, SULFUR lotion

  • NDC Code(s): 54295-307-20, 54295-307-23
  • Packager: Trinity Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 27, 2020

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  • SPL UNCLASSIFIED SECTION

  • DESCRIPTION

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

    Structural Formula

    Each gram of sulfacetamide sodium 10% and sulfur 5% contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP in a cream containing: Benzyl Alcohol, Emulsifying Wax, Hamaelis virginiana (Witch Hazel) Distillate, Kaolin, Propanediol, Propylene Glycol, Purified Water, Quillaja (Quillaia) saponaria Extract, Silicon Dioxide, and Sodium Thiosulfate.

  • 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, sulfacetamide sodium 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 & USAGE

    INDICATIONS:
    Sulfacetamide sodium and sulfur cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS:
    Sulfacetamide sodium and sulfur cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sulfacetamide sodium and sulfur cleanser is not to be used by patients with kidney disease.

  • WARNINGS

    WARNINGS:
    Although rare, sensitivity to sulfacetamide sodium 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 - lf 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 sulfacetamide sodium 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

    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 & IMPAIRMENT OF FERTILITY

    Carcinogenesis, Mutagenesis and Impairment of Fertility - Longterm studies in animals have not been performed to evaluate carcinogenic potential.

  • PREGNANCY

    Pregnancy: Category C - Animal reproduction studies have not been conducted with sulfacetamide sodium and sulfur lotion. It is also not known whether sulfacetamide sodium and sulfur cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide sodium and sulfur cleanser should be given to a pregnant woman only if clearly needed.

  • NURSING MOTHERS

    Nursing Mothers - It is not known whether sulfacetamide sodium is excreted in the human milk following topical use of sulfacetamide sodium and sulfur lotion. 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 sulfacetamide sodium and sulfur 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, sulfacetamide sodium may cause local irritation.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION:
    Apply 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 lather. RInse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off product sooner or using less often.

  • HOW SUPPLIED

    HOW SUPPLIED:
    Sulfacetamide sodium 10% and sulfur 5% cleanser is supplied in
    6 oz (170 g) tube      NDC 54295-307-23
    2 x 6 oz (170 g) tubes NDC 54295-307-20

    Store at 20°-25°C (68°-77°F), excursions permited between 15°-30°C (59°-86°F). Brief exposure to temperatures up to 40° (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.

    Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

    Rx Only


    Marketed by:
    Trinity Pharmaceuticals, LLC
    1 International Plaza, Suite 550
    Philadelphia, PA 19113
    TrinityPharmaLLC.com

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    SULFACETAMIDE SODIUM, SULFUR 
    sulfacetamide sodium, sulfur lotion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54295-307
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM100 mg  in 1 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR50 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54295-307-23170.1 g in 1 TUBE; Type 0: Not a Combination Product07/01/2013
    2NDC:54295-307-20340.2 g in 1 BOTTLE; Type 0: Not a Combination Product07/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2013
    Labeler - Trinity Pharmaceuticals, LLC (078671698)
    Registrant - Trinity Pharmaceuticals, LLC (078671698)