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Sulfatol Gel

Generic Name: sulfacetamide sodium and sulfur
Dosage Form: gel

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.

Sulfatol™ Gel (Sodium Sulfacetamide 10%, and Sulfur 5%)

Rx Only

Sulfatol Gel 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:

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Each mL of Sulfatol™ Gel (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%, Benzyl Alcohol, Cetyl Alcohol, Cocoglycerides, Dimethicone, Disodium EDTA, Fragrance, Glyceryl and PEG-100 Stearate, Isopropyl Myristate, Light Mineral Oil, Polysorbate 60, Propylene Glycol, Sodium Thiosulfate, Sorbitan Monostearate, Stearyl Alcohol, Purified Water, Xanthan Gum, and Zinc Ricinoleate.

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

Contraindications

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

Sulfatol Gel Dosage and Administration

Sulfatol Gel: Cleanse affected areas. Apply a thin film of Sulfatol™ Gel to affected areas 1 to 3 times daily, or as directed by a physician.

How is Sulfatol Gel Supplied

Sulfatol™ Gel is available in a 1.5 fl. oz. (45mL) tube. NDC 51991-172-45

Storage

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

Protect from freezing. Keep tube tightly closed.

Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487

Manufactured by: Groupe Parima Inc., Montréal, QC Canada H4S 1X6

06/07

PRINCIPAL DISPLAY PANEL - 45 mL Carton

Breckenridge
Pharmaceutical, Inc.

NDC 51991-172-45

Sulfatol™ Gel
Sodium Sulfacetamide 10% and Sulfur 5%
Rx ONLY
Net Wt. 1.5 fl. oz. (45mL)

Skin Gel
For The Topical Treatment Of

  • Acne Vulgaris
  • Acne Rosacea
  • Seborrheic Dermatitis
SULFATOL 
sulfacetamide sodium and sulfur gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-172
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
Urea  
benzyl alcohol  
cetyl alcohol  
coco-glycerides  
dimethicone  
Edetate Disodium  
Polyoxyl 100 Stearate  
isopropyl myristate  
light mineral oil  
polysorbate 60  
propylene glycol  
sodium thiosulfate  
sorbitan monostearate  
stearyl alcohol  
water  
xanthan gum  
zinc ricinoleate  
glyceryl monostearate  
Product Characteristics
Color YELLOW (yellow, smooth) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-172-45 1 TUBE (TUBE) in 1 CARTON
1 45 mL in 1 TUBE
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: 12/2010
 
Breckenridge Pharmaceutical, Inc.
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