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DESCRIPTION:

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:

Each gram of SE 10-5 SS (sodium sulfacetamide USP 10% and sulfur USP 5%) Cream contains: Active: Sodium Sulfacetamide 10% (100 mg) and Sulfur 5% (50 mg). Inactive: Benzyl Alcohol, Emulsifying Wax, Fragrance, Hamaelis virginiana (Witch Hazel) Distillate, Kaolin, Propanediol, Purified Water, Quillaja (Quillaia) saponaria Extract, Silicon Dioxide, Sodium Hydroxide, and Sodium Thiosulfate.

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:

SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS:

SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream 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.

Sodium sulfacetamide contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people (see CONTRAINDICATIONS section)."

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container 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 – Longterm studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy: Category C – Animal reproduction studies have not been conducted with SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream. It is also not known whether SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream should be given to a pregnant woman only if clearly needed.

Nursing Mothers – It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream. 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 SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream 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:

Use once daily or as directed by your physician. Wet skin. Apply in a film to entire face, avoiding contact with eyes or mucous membranes. Wait 10 minutes or until dry. Rinse thoroughly with water and pat dry.

HOW SUPPLIED:

SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream is available in a 4 oz. tube (NDC 13925-114-04).

Store at controlled room temperature 20° - 25°C (68° - 77° F).

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

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Manufactured For:

Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401

12/09

SETON PHARMACEUTICALS

PACKAGE LABEL- 113.4 g Tube Carton

NDC 13925-114-04        Rx Only

SE 10-5 SS CREAM

(sodium sulfacetamide 10% and sulfur 5%)

4 oz. Cream

SETON PHARMACEUTICALS