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Name:Sodium Sulfacetamide And Sulfur Aqueous
Manufacturer:E. Fougera And Co., A Division Of Nycomed Us Inc.
Category:Prescription Marketed Drugs


SODIUM SULFACETAMIDE 10% AND SULFUR 5% AQUEOUS CLEANSER (in a Urea vehicle) SODIUM SULFACETAMIDE 10% AND SULFUR 5% AQUEOUS GEL(in a Urea vehicle)

SODIUM SULFACETAMIDE AND SULFUR  AQUEOUS - sulfacetamide sodium and sulfur gel 
E. Fougera and Co., A division of Nycomed US 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.

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SODIUM SULFACETAMIDE 10% AND SULFUR 5% AQUEOUS CLEANSER (in a Urea vehicle) SODIUM SULFACETAMIDE 10% AND SULFUR 5% AQUEOUS GEL(in a Urea vehicle)

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:

image structure

Each mL of Sodium Sulfacetamide 10% and Sulfur 5% Cleanser in a Urea vehicle contains 100 mg of Sodium Sulfacetamide and 50 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 aluminium silicate, xanthan gum, methylparaben, disodium EDTA, butylated hydroxytoluene, sodium thiosulfate, fragrance, propylparaben, and purified water.

Each mL of Sodium Sulfacetamide 10% and Sulfur 5% Gel in a Urea vehicle contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur in an emulsion base containing Urea 10%, propylene glycol, isopropyl myristate, mineral oil, polysorbate 60, sorbitan monostearate, cetyl alcohol, coco-glycerides, stearyl alcohol, benzyl alcohol, glyceryl stearate and PEG-100 stearate, dimethicone, fragrance, disodium EDTA, xanthan gum, zinc ricinoleate, sodium thiosulfate and purifed 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 5% Cleanser and Sodium Sulfacetamide 10% and Sulfur 5% Gel are indicated in the topical control acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS: Sodium Sulfacetamide 10% and Sulfur 5% Cleanser and Sodium Sulfacetamide 10% and Sulfur 5% Gel are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation.  Sodium Sulfacetamide 10% and Sulfur 5% Cleanser and Sodium Sulfacetamide 10% and Sulfur 5% Gel are 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.

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 Sodium Sulfacetamide 10% and Sulfur 5% Cleanser and Sodium Sulfacetamide 10% and Sulfur 5% Gel.  It also is not known whether Sodium Sulfacetamide 10% and Sulfur 5% Cleanser and Sodium Sulfacetamide 10% and Sulfur 5% Gel can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Sodium Sulfacetamide 10% and Sulfur 5% Cleanser and Sodium Sulfacetamide 10% and Sulfur 5% Gel 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% Cleanser and Sodium Sulfacetamide 10% and Sulfur 5% Gel.  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 5% Cleanser and Sodium Sulfacetamide 10% and Sulfur 5% Gel are administered to a nursing mother.

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 5% 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.

Sodium Sulfacetamide 10% and Sulfur 5% Gel: Cleanse affected areas.  Apply a thin layer into affected areas 1 to 3 times daily, or as directed by a physician.

HOW SUPPLIED:  Sodium Sulfacetamide 10% and Sulfur 5% Cleanser, NDC 0168-0662-12

Store Sodium Sulfacetamide 10% and Sulfur 5% Cleanser at 15°-25°C (59°-77°F).

Sodium Sulfacetamide 10% and Sulfur 5% Gel, NDC 0168-0661-45

Store Sodium Sulfacetamide 10% and Sulfur 5% Gel at 15°-30°C (59°-86°F).

Protect from freezing.

Manufactured for:

E. FOUGERA AND CO.

A division of Nycomed US Inc.

Melville, New York 11747

Manufactured by:

Groupe PARIMA, Inc

Montreal, QC H4S 1X6 CANADA

U.S. Patent No. 6,429,231

image tube

image carton








SODIUM SULFACETAMIDE AND SULFUR   AQUEOUS
sodium sulfacetamide and sulfur gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0661
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 50 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
UREA  
PROPYLENE GLYCOL  
ISOPROPYL MYRISTATE  
LIGHT MINERAL OIL  
POLYSORBATE 60  
SORBITAN MONOSTEARATE  
CETYL ALCOHOL  
COCO-GLYCERIDES  
STEARYL ALCOHOL  
BENZYL ALCOHOL  
GLYCERYL MONOSTEARATE  
POLYOXYL 100 STEARATE  
DIMETHICONE  
EDETATE DISODIUM  
XANTHAN GUM  
GLYCERYL RICINOLEATE  
SODIUM THIOSULFATE  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0661-45 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 45 mL in 1 TUBE This package is contained within the CARTON (0168-0661-45)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/18/2010

Labeler - E. Fougera and Co., A division of Nycomed US Inc. (043838424)
Registrant - Nycomed US Inc. (043838424)
Establishment
Name Address ID/FEI Operations
Groupe Parima Inc 252437850 manufacture

Revised: 02/2010 E. Fougera and Co., A division of Nycomed US Inc.



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


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