Dosage Form: topical solution
Sulfatol™ Cleanser (Sodium Sulfacetamide 10%, and Sulfur 5% in a Urea Vehicle)
Rx Only
Sulfatol Cleanser 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:
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.
Sulfatol Cleanser - 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.
Sulfatol Cleanser 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 is Sulfatol Cleanser 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
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| 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 | |
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Compare Sulfatol Cleanser with other medications
- Acne
- Rosacea
- Seborrheic Dermatitis
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