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Sodium Sulfacetamide and Sulfur Wash

Dosage Form: wash

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 9% and Sulfur 4.5% Wash Kit

DESCRIPTION:

Each mL of Sodium Sulfacetamide 9% and Sulfur 4.5% Wash contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation of: aloe vera, butylated hydroxytoluene, cetyl alcohol, disodium EDTA, disodium oleamido MEA sulfosuccinate, fragrance, glyceryl stearate (and) PEG-100 stearate, green tea extract, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol and xanthan gum.

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Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C8H9N2NaO3S·H2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

INDICATIONS:

Sodium Sulfacetamide 9% and Sulfur 4.5% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS:

Sodium Sulfacetamide 9% and Sulfur 4.5% 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.

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.

WARNINGS AND PRECAUTIONS:

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes, lips and mucous membranes.

Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this product 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.

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 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:Pregnancy Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product 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 this product. However, small amounts of orally administered sulfonamides have been reported to be excreted in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in children under the age of 12 has not been established.

ADVERSE REACTIONS:

Although rare, sodium sulfacetamide may cause local irritation. You should call your doctor for medical advice about side effects. To report a serious adverse event, call 1-866-762-2365.

DOSAGE AND ADMINISTRATION:

Wash affected areas once or twice daily, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10 to 20 seconds, working into a full lather, rinse thoroughly and pat dry. If skin dryness occurs, it may be controlled by rinsing product off sooner or using less frequently.

HOW SUPPLIED:

Sodium Sulfacetamide 9% and Sulfur 4.5% Wash is supplied in a 16 oz (454 g) bottle, NDC 44523-605-16.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Protect from freezing. Keep bottle tightly closed.

KEEP OUT OF REACH OF CHILDREN.

Manufactured for:

BIOCOMP PHARMA®, INC.

San Antonio, TX 78230 1355

C01 Rev 012120

Established Pharmacological Class
Substance Pharmacological Class
Daily Moisturizing Lotions, Oils, Powders, and Creams
SODIUM SULFACETAMIDE AND SULFUR 
sodium sulfacetamide, sulfur kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44523-609
Packaging
# Item Code Package Description
1 NDC:44523-609-23 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, PLASTIC 454 g
Part 2 1 BOTTLE, PLASTIC 473 mL
Part 1 of 2
SODIUM SULFACETAMIDE AND SULFUR 
sodium sulfacetamide, sulfur lotion
Product Information
Item Code (Source) NDC:44523-605    
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 90 mg  in 1 g
SULFUR (SULFUR) SULFUR 45 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF  
BUTYLATED HYDROXYTOLUENE  
CETYL ALCOHOL  
EDETATE DISODIUM  
DISODIUM OLEAMIDO MEA-SULFOSUCCINATE  
GLYCERYL STEARATE SE  
PEG-100 STEARATE  
GREEN TEA LEAF  
MAGNESIUM ALUMINUM SILICATE  
METHYLPARABEN  
PROPYLPARABEN  
WATER  
SODIUM COCOYL ISETHIONATE  
SODIUM METHYL COCOYL TAURATE  
SODIUM THIOSULFATE  
STEARYL ALCOHOL  
XANTHAN GUM  
Product Characteristics
Color yellow (light yellow) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:44523-605-16 454 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/15/2011
Part 2 of 2
DAILY MOISTURIZING 
Product Information
Ingredients
Ingredient Name Quantity
WATER  
GLYCERYL STEARATE SE  
GLYCERIN  
PEG-100 STEARATE  
CETYL ALCOHOL  
PALM KERNEL ACID  
DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE  
SODIUM COCOAMPHOACETATE  
CHOLESTEROL  
DISODIUM LAURETH SULFOSUCCINATE  
POLYACRYLAMIDE (10000 MW)  
HELIANTHUS ANNUUS SEED WAX  
CAPRYLYL GLYCOL  
PROPYLENE GLYCOL  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)  
PHENOXYETHANOL  
SODIUM COCOYL ISETHIONATE  
COCAMIDOPROPYL BETAINE  
SODIUM METHYL COCOYL TAURATE  
C13-14 ISOPARAFFIN  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)  
SODIUM CHLORIDE  
NIACINAMIDE  
EDETATE SODIUM  
HEXYLENE GLYCOL  
CARBOMER 934  
LAURETH-7  
LEUCANTHEMUM VULGARE SEED  
CHAMAEMELUM NOBILE FLOWER  
HYALURONATE SODIUM  
Packaging
# Item Code Package Description
1 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 04/15/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/15/2011
Labeler - BioComp Pharma, Inc. (829249718)
Revised: 04/2013
 
BioComp Pharma, Inc.



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