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Sulfatol C Cream

Generic Name: sulfacetamide sodium and sulfur
Dosage Form: cream

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 C™ Cream

Rx Only

PRODUCT DESCRIPTION

Sulfatol C™ Cream (sulfacetamide sodium 10% and sulfur 5%) is available by prescription only and contains the following active ingredients: Sulfacetamide Sodium 10% and Sulfur 5%.

Chemically, sulfacetamide sodium is Acetamide, N-[(4-aminophenyl) sulfonyl], monosodium salt, monohydrate. The structural formula is:

INACTIVE INGREDIENTS: 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, Urea, Purified Water, Xanthan Gum, Zinc Ricinoleate.

Sulfatol C Cream - 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, sulfacetamide sodium 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 C™ Cream (sulfacetamide sodium 10% and sulfur 5%) is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications

Sulfatol C™ Cream is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sulfatol C™ Cream is not to be used by patients with kidney disease.

FOR EXTERNAL USE ONLY. Keep out of reach of children. Keep away from eyes. Keep tube tightly closed.

Warnings

Although rare, sensitivity to sulfacetamide sodium 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.

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 sulfacetamide sodium 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

Sulfatol C™ Cream is intended for external use only. Avoid contact with eyes, eyelids, lips, other mucous membranes (e.g., inside the nose), and any damaged areas of the skin, such as wounds or open sores. If accidental contact with one of these areas occurs, rinse thoroughly with water.

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 C™ Cream. It also is not known whether Sulfatol C™ Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfatol C™ Cream should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether sulfacetamide sodium is excreted in human milk following topical use of Sulfatol C™ Cream. 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 C™ Cream is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children under 12 years of age has not been established.

Possible Side Effects

Like any medication, Sulfatol C™ Cream may occasionally cause side effects in some people. Although uncommon, some possible side effects may include skin irritation such as redness, dryness, itching or swelling. If you experience excessive skin irritation, contact your physician.

Directions For Use

Apply Sulfatol C™ Cream to affected area(s) 1-3 times daily, or as directed by your physician.

1)
Cleanse your skin thoroughly before application.
2)
Apply a thin layer of Sulfatol C™ Cream to the affected area(s) as directed by your physician
3)
Start by using Sulfatol C™ Cream once daily to minimize dryness.

Then, increase application frequency to 2-3 times daily or as directed by your physician.

How is Sulfatol C Cream Supplied

Sulfatol C™ Cream (sulfacetamide sodium 10% and sulfur 5%) is available in 1 oz. tubes. (NDC 51991-559-41)

Storage

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

Dispense in original container.

Warning

Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

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

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

Iss: 9/08

PRINCIPAL DISPLAY PANEL - 28g tube carton

Breckenridge
Pharmaceutical, Inc.

NDC 51991-559-41

Sulfatol C™ Cream
Sulfacetamide Sodium 10% and Sulfur 5%

Rx Only
Net Wt. 1 oz. (28g)

Skin Cream
For The Topical Control Of

  • Acne Vulgaris
  • Acne Rosacea
  • Seborrheic Dermatitis
SULFATOL C 
sulfacetamide sodium and sulfur cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-559
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sulfacetamide Sodium (Sulfacetamide) Sulfacetamide Sodium 2.8 g  in 28 g
Sulfur (Sulfur) Sulfur 1.4 g  in 28 g
Inactive Ingredients
Ingredient Name Strength
Benzyl Alcohol  
Cetyl Alcohol  
Coco-glycerides  
Dimethicone  
Edetate Disodium  
Glycerin  
Polyoxyl 100 Stearate  
Isopropyl Myristate  
Light Mineral Oil  
Polysorbate 60  
Propylene Glycol  
Sodium Thiosulfate  
Sorbitan Monostearate  
Stearyl Alcohol  
Urea  
Water  
Xanthan Gum  
Product Characteristics
Color YELLOW (light-yellow) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-559-41 1 TUBE (TUBE) in 1 BOX
1 28 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 02/01/2009 09/30/2011
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Groupe Parima 252437850 MANUFACTURE
Revised: 05/2010
 
Breckenridge Pharmaceutical, Inc.



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