Prascion Cleanser

Generic Name: sodium sulfacetamide and sulfur

Dosage Form: topical soap
Prascion Cleanser (sodium sulfacetamide 10% and sulfur 5%) Rx only

DESCRIPTION:

Each gram of PRASCION (sodium sulfacetamide 10% and sulfur 5%) Cleanser contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP in a cleanser base containing Purified Water USP, Sodium Methyl Cocoyl Taurate, Disodium Oleamido MEA Sulfosuccinate, Sodium Cocoyl Isethionate, Cetyl Alcohol NF, Glyceryl Stearate (and) PEG 100 Stearate, Stearyl Alcohol NF, Magnesium Aluminum Silicate NF, Disodium EDTA USP, Methylparaben NF, Butylated Hydroxytoluene NF, Sodium Thiosulfate USP, Xanthan Gum NF, Fragrance, Propylparaben NF.


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, mono-hydrate. The structural formula is:

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:

PRASCION (sodium sulfacetamide 10% and

sulfur 5%) Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS:

PRASCION (sodium sulfacetamide 10% and sulfur 5%) Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. PRASCION (sodium sulfacetamide 10% and sulfur 5%) Cleanser 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 bottle 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, 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 (sodium sulfacetamide 10% and sulfur 5%) Cleanser. It is also not known whether PRASCION (sodium sulfacetamide 10% and sulfur 5%) Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PRASCION (sodium sulfacetamide 10% and 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 PRASCION (sodium sulfacetamide 10% and sulfur 5%) Cleanser. 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 PRASCION (sodium sulfacetamide 10% and 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.

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:

PRASCION (sodium sulfacetamide 10% and sulfur 5%) Cleanser is available in sizes of 6 oz (170.3 g), NDC 66993-902-06 and 12 oz (340.2 g), NDC 66993-902-12.

Store at 15°-25°C (59°- 77°F).

Manufactured for:

Prasco Laboratories

Mason, OH 45040 USA


Manufactured by:

Groupe Parima, Inc

Montreal, QC H4S 1X6

Canada

PRASCION  CLEANSER sodium sulfacetamide and sulfur  soap

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66993-902 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg  in 1 g SULFUR (SULFUR) SULFUR 50 mg  in 1 g

Inactive Ingredients Ingredient Name Strength WATER   SODIUM METHYL COCOYL TAURATE   DISODIUM OLEAMIDO MEA-SULFOSUCCINATE   SODIUM COCOYL ISETHIONATE   CETYL ALCOHOL   GLYCERYL MONOSTEARATE   PEG-100 STEARATE   STEARYL ALCOHOL   MAGNESIUM ALUMINUM SILICATE   EDETATE DISODIUM   METHYLPARABEN   BUTYLATED HYDROXYTOLUENE   SODIUM THIOSULFATE   XANTHAN GUM   PROPYLPARABEN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 66993-902-06 170.3 g In 1 BOTTLE None 2 66993-902-12 340.2 g In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/05/2011

Labeler - Prasco Laboratories (065969375)

Registrant - Groupe PARIMA, Inc. (252437850)

Establishment
Name	Address	ID/FEI	Operations
Groupe PARIMA, Inc.		252437850	manufacture

Revised: 08/2011Prasco Laboratories

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