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Name:Sulfatol Cleanser
Manufacturer:Breckenridge Pharmaceutical, Inc.
Category:Prescription Marketed Drugs


Sulfatol™ Cleanser (Sodium Sulfacetamide 10%, and Sulfur 5% in a Urea Vehicle)

SULFATOL CLEANSER - sulfacetamide sodium and sulfur solution 
Breckenridge Pharmaceutical, Inc.

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.

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Sulfatol™ Cleanser (Sodium Sulfacetamide 10%, and Sulfur 5% in a Urea Vehicle)

Rx Only

DESCRIPTION

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

Chemical Structure

Each mL of Sulfatol™ Cleanser (Sodium Sulfacetamide 10%, and Sulfur 5% in a Urea vehicle) contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur in an emulsion base containing Urea 10%, BHT, Cetyl Alcohol, Disodium EDTA, Fragrance, Disodium Oleamido MEA Sulfosuccinate, Glyceryl and PEG-100 Stearate, Magnesium Aluminum Silicate, Methylparaben, Propylparaben, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol, Purified Water, Xanthan Gum.

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

Sulfatol™ Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS

Sulfatol™ Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sulfatol™ 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, 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 Sulfatol™ Cleanser. It also is not known whether Sulfatol™ Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfatol™ Cleanser 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 Sulfatol™ 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 Sulfatol™ 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

Sulfatol™ Cleanser

Wash affected area 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 off cleanser sooner or using less often.

HOW SUPPLIED

Sulfatol™ Cleanser is available in a 355 mL bottle. NDC 51991-173-26

Storage

Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F). See USP Controlled Room Temperature.

Protect from freezing.

Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487
Manufactured by: Groupe Parima Inc., Montréal, QC Canada H4S 1X6

06/07

PRINCIPAL DISPLAY PANEL - 355 mL Bottle Carton

Breckenridge
Pharmaceutical, Inc.

NDC 51991-173-26

Sulfatol™ Cleanser
Sodium Sulfacetamide 10%, Sulfur 5% in a Urea vehicle

Skin Cleanser
For The Topical Treatment Of

  • Acne Vulgaris
  • Acne Rosacea
  • Seborrheic Dermatitis

Rx ONLY

Net Wt. 355 mL

PRINCIPAL DISPLAY PANEL - 355 mL Bottle Carton

SULFATOL CLEANSER 
sulfacetamide sodium and sulfur solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51991-173
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 mL
Sulfur (Sulfur) Sulfur 50 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Butylated Hydroxytoluene  
Cetyl Alcohol  
Edetate Disodium  
Glyceryl Monostearate  
Disodium Oleamido MEA-Sulfosuccinate  
Polyoxyl 100 Stearate  
Magnesium Aluminum Silicate  
Methylparaben  
Propylparaben  
Sodium Cocoyl Isethionate  
Sodium Thiosulfate  
Stearyl Alcohol  
Urea  
Water  
Xanthan Gum  
Product Characteristics
Color YELLOW (light-yellow) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51991-173-26 1 BOTTLE ( BOTTLE) in 1 BOX contains a BOTTLE
1 355 mL in 1 BOTTLE This package is contained within the BOX (51991-173-26)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 03/01/2005 09/30/2011

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Groupe Parima 252437850 MANUFACTURE

Revised: 11/2010 Breckenridge Pharmaceutical, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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