Label: PRASCION RA CREAM WITH SUNSCREENS- sulfacetamide sodium and sulfur cream 

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

Drug Label Information

Updated 08/09

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  • DESCRIPTION

    Each gram of PRASCION RA Cream With Sunscreens contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a cream containing avobenzone, benzyl alcohol, C12-15 alkyl benzoate, cetostearyl alcohol, dimethicone, edetate disodium, emulsifying wax, monobasic sodium phosphate, octinoxate, propylene glycol, purified water, sodium thiosulfate, steareth-2, steareth-21.

    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:

    Image of chemical structure

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  • 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 in 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

    PRASCION RA Cream With Sunscreens is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

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  • CONTRAINDICATIONS

    PRASCION RA Cream With Sunscreens is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. This drug 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.

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  • PRECAUTIONS

    Enter section text here

    General

    If irritation develops, use of the product should be discontinued and appropriate therapy instituted. For external use only. Keep away from eyes. 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 epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. Keep out of reach of children.

    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 PRASCION RA Cream with Sunscreens. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It 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 PRASCION RA Cream With Sunscreens. 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 this drug is administered to a nursing woman.

    Pediatric Use

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

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  • ADVERSE REACTIONS

    Although rare, sodium sulfacetamide may cause local irriation.

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  • DOSAGE AND ADMINISTRATION

    Apply a thin film of PRASCION RA Cream With Sunscreens to affected areas 1 to 3 times daily.

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  • HOW SUPPLIED

    45 g tubes (NDC 66993-925-45)

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  • STORAGE AND HANDLING

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

    U.S. Patent No. 7,022,332   Patent Pending

    Prasco Logo

    Manufactured for: Prasco Laboratories, Mason, OH 45040  USA

    Manufactured by: Stiefel Laboratories, Inc., Coral Gables, FL 33134

    Iss. 01/09

    302652

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  • INGREDIENTS AND APPEARANCE
    PRASCION RA CREAM  WITH SUNSCREENS
    sodium sulfacetamide and sulfur cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66993-925
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sulfacetamide Sodium (Sulfacetamide ) Sulfacetamide Sodium 100 mg  in 45 g
    Sulfur (Sulfur) Sulfur 50 mg  in 45 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66993-925-45 45 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved other 06/30/2009
    Labeler - Prasco Laboratories (065969375)
    Establishment
    Name Address ID/FEI Business Operations
    Stiefel Laboratories, Inc. 002063378 manufacture
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