Prascion FC Cleansing Cloths

Generic Name: sodium sulfacetamide and sulfur
Dosage Form: topical cloth

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Prascion® FC (sodium sulfacetamide 10% and sulfur 5%) Facial Cleansing Cloths

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 cloth of Prascion® FC (sodium sulfacetamide USP 10% and sulfur USP 5%) Facial Cleansing Cloths is coated with a cleanser-based formulation. Each gram of this cleanser-based formulation contains 100 mg of sodium sulfacetamide USP and 50 mg of sulfur USP. The cleanser base consists of: butylated hydroxytoluene NF, cetyl alcohol NF, disodium oleamido MEA sulfosuccinate, edetate disodium USP, fragrance, glyceryl stearate/PEG-100 stearate, glycerin USP, methylparaben NF, propylparaben NF, purified water USP, sodium cocoyl isethionate, sodium lauryl sulfoacetate, sodium thiosulfate USP, stearyl alcohol NF.

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 FC Facial Cleansing Cloths are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS: Prascion FC Facial Cleansing Cloths are 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.

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 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 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® FC Facial Cleansing Cloths. 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 FC Facial Cleansing Cloths. 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.

ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.

DOSAGE AND ADMINISTRATION:
Prascion FC Facial Cleansing Cloths: Wash affected areas with cleansing cloth once or twice daily, or as directed by your physician. Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10-20 seconds avoiding eyes. Rinse thoroughly and pat dry. Throw away cloth. Do not flush.

HOW SUPPLIED: Prascion® (sodium sulfacetamide 10% and sulfur 5%) Facial Cleansing Cloths are available in
boxes of 30 cloths (3.7 g each)    NDC 66993-905-30
boxes of 60 cloths (3.7 g each)    NDC 66993-905-60

Store at 15°-25°C (59°- 77°F).


Manufactured for: Prasco Laboratories
                           Mason, Ohio 45040 USA
Manufactured by: Groupe Parima, Inc
                           Montreal, QC H4S 1X6 CANADA

PRASCION  FC
sodium sulfacetamide and sulfur cloth
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66993-905
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
BUTYLATED HYDROXYTOLUENE  
CETYL ALCOHOL  
DISODIUM OLEAMIDO MEA-SULFOSUCCINATE  
EDETATE DISODIUM  
GLYCERYL MONOSTEARATE  
PEG-100 STEARATE  
GLYCERIN  
METHYLPARABEN  
PROPYLPARABEN  
SODIUM COCOYL ISETHIONATE  
SODIUM LAURYL SULFOACETATE  
SODIUM THIOSULFATE  
STEARYL ALCOHOL  
Packaging
# Item Code Package Description
1 NDC:66993-905-30 30 POUCH (POUCH) in 1 BOX
1 3.7 g in 1 POUCH
2 NDC:66993-905-60 60 POUCH (POUCH) in 1 BOX
2 3.7 g in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/08/2011
Labeler - Prasco Laboratories (065969375)
Registrant - Groupe PARIMA, Inc. (252437850)
Establishment
Name Address ID/FEI Operations
Groupe PARIMA, Inc. 252437850 manufacture
Revised: 08/2011
 
Prasco Laboratories



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