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Name:Sodium Sulfacetamide Sulfur
Manufacturer:River's Edge Pharmaceuticals, Llc
Category:Prescription Marketed Drugs


Sodium Sulfacetamide 10% Sulfur 4% Wash

SODIUM SULFACETAMIDE SULFUR  - sulfacetamide sodium, sulfur, meradimate, titanium dioxide   
River's Edge Pharmaceuticals, LLC

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.

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Sodium Sulfacetamide 10% Sulfur 4% Wash

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.

Each mL of Sodium Sulfacetamide 10% and Sulfur 4% Wash contains 100 mg of sodium sulfacetamide and 40 mg of sulfur in an emulsion base containing urea 10%, sodium methyl cocoyl taurate, disodium oleamido MEA sulfosuccinate, sodium cocoyl isethionate, cetyl alcohol, glyceryl stearate and PEG 100 stearate, stearyl alcohol, magnesium aluminum silicate, xanthan gum, methylparaben, disodium EDTA, butylated hydroxytoluene, sodium thiosulfate, fragrance, propylparaben and purified water.

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:

Sodium Sulfacetamide 10% and Sulfur 4% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS:

Sodium Sulfacetamide 10% and Sulfur 4% Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% and Sulfur 4% Wash 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 witheyes, 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 Sodium Sulfacetamide 10% and Sulfur 4% Wash. It also is not known whether Sodium Sulfacetamide
10% and Sulfur 4% Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% and Sulfur 4% 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 4% 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 Sodium Sulfacetamide 10% and Sulfur 4% Wash 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:


Sodium Sulfacetamide 10% and Sulfur 4% Wash: 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 clarifying wash sooner or using less often.

HOW SUPPLIED:

Sodium Sulfacetamide 10% and Sulfur 4% Wash is available in a 16 fl. oz (473 mL) bottle, NDC 68032-262-16.

Store Sodium Sulfacetamide 10% and Sulfur 4% Wash at controlled room temperature 15°-30°C (59°-86°F).

Protect from freezing.

Manufactured for:
River's Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Iss. 09/07 262-11

PACKAGING:

carton


SODIUM SULFACETAMIDE SULFUR 
sulfacetamide sodium, sulfur, meradimate, titanium dioxide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68032-311
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68032-311-91 1 KIT ( KIT) in 1 CARTON None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE   473 mL
Part 2 1 TUBE   42.5 g
Part 1 of 2
SODIUM SULFACETAMIDE SULFUR 
sulfacetamide sodium, sulfur liquid
Product Information
Item Code (Source) NDC:68032-262
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 40 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
UREA  
DISODIUM OLEAMIDO MEA-SULFOSUCCINATE  
SODIUM COCOYL ISETHIONATE  
CETYL ALCOHOL  
GLYCERYL MONOSTEARATE  
POLYOXYL 100 STEARATE  
STEARYL ALCOHOL  
MAGNESIUM ALUMINUM SILICATE  
XANTHAN GUM  
METHYLPARABEN  
EDETATE DISODIUM  
BUTYLATED HYDROXYTOLUENE  
SODIUM THIOSULFATE  
PROPYLPARABEN  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 68032-262-16 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/01/2007 08/31/2011

Part 2 of 2
MERATAN 
meradimate, titanium dioxide cream
Product Information
Item Code (Source) NDC:68032-310
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MERADIMATE (MERADIMATE) MERADIMATE 50 mg  in 1 g
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE 50 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BUTYLPARABEN  
CETYL ALCOHOL  
GLYCERYL MONOSTEARATE  
FERRIC OXIDE RED  
ISOPROPYL MYRISTATE  
METHYLPARABEN  
PROPYLENE GLYCOL  
WATER  
QUATERNIUM-15  
TALC  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 68032-310-42 42.5 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/01/2008 08/31/2011


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2008 08/31/2011

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 12/2010 River's Edge Pharmaceuticals, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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