Sodium Sulfacetamide and Sulfur Aqueous Gel

Dosage Form: gel
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.

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 NDC Product Code (Source) 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

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 42808-111-45 1 TUBE In 1 CARTON contains a TUBE 1 45 g In 1 TUBE This package is contained within the CARTON (42808-111-45)

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: 08/2011Exact-Rx, Inc.

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