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Sodium Sulfacetamide and Sulfur Aqueous Gel

Generic Name: sulfacetamide sodium and sulfur
Dosage Form: gel

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.

10% Sodium Sulfacetamide and Sulfur 5% Aqueous Gel (in a Urea vehicle)
Rx only

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:

Each mL of 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle) contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in an emulsion base containing 10% Urea, propylene glycol, isopropyl myristate, mineral oil, polysorbate 60, sorbitan monostearate, cetyl alcohol, cocoglycerides, stearyl alcohol, benzyl alcohol, glyceryl stearate and PEG 100 stearate, dimethicone, fragrance, disodium EDTA, xanthan gum, zinc pyrithione, sodium thiosulfate, purified water, magnesium aluminum silicate, and methyl paraben.

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: 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle) is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS: 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle) is contraindicated for patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation.  10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle) is not to be used in patients with kidney disease.

WARNINGS: Rarely, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug tor 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. Use particular caution on areas of denuded or abraded skin.

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 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle). It is also not known whether 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle) 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 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle). However, small amounts of orally administered sulfonamides have been reported to be excreted in human milk. For this reason, and because many drugs are excreted in human milk, caution should be exercised when 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle) is administered to a nursing woman.

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

ADVERSE REACTIONS: Rarely, sodium sulfacetamide may cause local irritation.

Call your physician for medical advice about side effects.

DOSAGE AND ADMINISTRATION:

10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle): Cleanse affected areas. Apply a thin film into affected areas 1 to 3 times daily, or as directed by a physician.

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HOW SUPPLIED:

10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle): is available in a 1.5 fl. oz (45 g) tube, NDC 42808-0111-45

Store 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle): at 15 to 30°C (59 to 86°F).

Protect from freezing.

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

00-0111-45-205-00

Iss:6/11

PACKAGE LABEL - 1.5 oz (45 g)

For External Use Only

NDC 42808-0111-45        Rx Only

Sodium
Sulfacetamide
& Sulfur

(Sodium Sulfacetamide 10%
& Sulfur 5% in a Urea Vehicle)

10%/5%

AQUEOUS GEL

Exact-Rx.
INCORPORATED

Net Wt. 1.5 oz (45 g)

SODIUM SULFACETAMIDE, SULFUR  
sodium sulfacetamide, sulfur gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42808-111
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 g
SULFUR (SULFUR) SULFUR 50 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
UREA  
PROPYLENE GLYCOL  
ISOPROPYL MYRISTATE  
MINERAL OIL  
POLYSORBATE 60  
SORBITAN MONOSTEARATE  
CETYL ALCOHOL  
COCO-GLYCERIDES  
STEARYL ALCOHOL  
BENZYL ALCOHOL  
GLYCERYL MONOSTEARATE  
POLYOXYL 100 STEARATE  
DIMETHICONE  
EDETATE DISODIUM  
XANTHAN GUM  
PYRITHIONE ZINC  
SODIUM THIOSULFATE  
WATER  
MAGNESIUM ALUMINUM SILICATE  
METHYLPARABEN  
Packaging
# Item Code Package Description
1 NDC:42808-111-45 1 TUBE (TUBE) in 1 CARTON
1 45 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2011
Labeler - Exact-Rx, Inc. (137953498)
Revised: 08/2011
 
Exact-Rx, Inc.



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