SODIUM SULFACETAMIDE 10 AND SULFUR 5- sulfur and sulfacetamide sodium solution 
Perrigo New York 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.

----------

Sodium Sulfacetamide 10% and Sulfur 5% Wash

Rx Only

DESCRIPTION:

Each gram of Sodium Sulfacetamide 10% and Sulfur 5% Wash contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a wash containing butylated hydroxytoluene, cetyl alcohol, edetate disodium, glyceryl stearate, lactic acid, magnesium aluminum silicate, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium C14-16 olefin sulfonate, sodium thiosulfate, stearyl alcohol, white petrolatum, and xanthan gum.

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:

Image 1

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 AND USAGE:

Sodium Sulfacetamide 10% and Sulfur 5% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS:

Sodium Sulfacetamide 10% and Sulfur 5% Wash is 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 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility -

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy:

Teratogenic Effects:

Pregnancy Category C -

Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% and Sulfur 5% Wash. It is also not known whether Sodium Sulfacetamide 10% and Sulfur 5% Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% and Sulfur 5% Wash 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 Sodium Sulfacetamide 10% and Sulfur 5% Wash. 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:

Wash affected areas once or twice daily, or as directed by your physician. Avoid contact with eyes and mucous membranes. Wet skin and liberally apply to areas to be treated, 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 wash off sooner or using less often.

HOW SUPPLIED

Sodium Sulfacetamide 10% and Sulfur 5% Wash is available as follows:

6 oz. (170.1 g) tube (NDC 45802-942-01)

12 oz. (340.2 g) package containing two 6 oz. (170.1 g) tubes (NDC 45802-942-02)

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

MANUFACTURED BY

STIEFEL LABORATORIES, INC.,

CORAL GABLES, FL 33134

Image 2

Rev. 09/07

4V800 RC J1

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Sodium Sulfacetamide 10% and Sulfur 5% Wash

Rx Only

Sodium Sulfacetamide 10% and Sulfur 5% Wash Carton Image 1

Sodium Sulfacetamide 10% and Sulfur 5% Wash Carton Image 1

Sodium Sulfacetamide 10% and Sulfur 5% Wash Carton Image 2

Sodium Sulfacetamide 10% and Sulfur 5% Wash Carton Image 2

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Sodium Sulfacetamide 10% and Sulfur 5% Wash

Rx Only

Sodium Sulfacetamide 10% and Sulfur 5% Wash Tube Image 1

Sodium Sulfacetamide 10% and Sulfur 5% Wash Tube Image 1

Sodium Sulfacetamide 10% and Sulfur 5% Wash Tube Image 2

Sodium Sulfacetamide 10% and Sulfur 5% Wash Tube Image 2

SODIUM SULFACETAMIDE 10 AND SULFUR 5 
sodium sulfacetamide, sulfur solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-942
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 50 mg  in 1 g
SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM 100 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LACTIC ACID (UNII: 33X04XA5AT)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
SODIUM THIOSULFATE (UNII: HX1032V43M)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
PETROLATUM (UNII: 4T6H12BN9U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:45802-942-02 2 in 1 CARTON
1 170.1 g in 1 TUBE
2 NDC:45802-942-01 1 in 1 CARTON
2 170.1 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/06/2008
Labeler - Perrigo New York Inc (078846912)

Revised: 3/2012
Document Id: 0e76c520-d02a-4064-bcda-fc45cf9e6fa3
Set id: 0e76c520-d02a-4064-bcda-fc45cf9e6fa3
Version: 1
Effective Time: 20120305
 
Perrigo New York Inc