Sulfacleanse 8/4

Generic Name: sodium sulfacetamide and sulfur

Dosage Form: topical lotion
SULFACLEANSE TM 8/4 TOPICAL SUSPENSION REV.1.0 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.

Each mL of SulfaCleanse™ 8/4 contains 80mg of sodium sulfacetamide and 40mg of sulfur in a formulation consisting of: aloe, butylated hydroxytoluene, cetyl alcohol, disodium oleamido MEA sulfosuccinate, edetate disodium, fragrance, glyceryl stearate, green tea, magnesium aluminum silicate, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, xanthan gum.

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.

SulfaCleanse™ 8/4 is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

SulfaCleanse™ 8/4 is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SulfaCleanse™ 8/4 is not to be used by patients with kidney disease.

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 container tightly closed.

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.

Category C – Animal reproduction studies have not been conducted with SulfaCleanse™ 8/4. It is also not known whether SulfaCleanse™ 8/4 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SulfaCleanse™ 8/4 should be given to a pregnant woman only if clearly needed.

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of SulfaCleanse™ 8/4. 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 SulfaCleanse™ 8/4 is administered to a nursing woman.

Safety and effectiveness in children under the age of 12 has not been established.

Although rare, sodium sulfacetamide may cause local irritation.

Apply SulfaCleanse™ 8/4 once or twice daily to affected areas, or as directed by your physician. 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 SulfaCleanse™ 8/4 sooner or using less often.

SulfaCleanse™ 8/4 is available in a 16 fl. oz. (473 mL) bottle, NDC 42546-175-16.

Store at controlled room temperature 20°-25° C (68°-77° F); excursions permitted to 15°-30°C (59°-86°F).

Protect from freezing.


KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

NDC 42546-175-16

SulfaCleanseTM 8/4 (sodium sulfacetamide 8% and sulfur 4%)

Topical Suspension in a vehicle containing Green Tea and Aloe

Rx only

16 fl oz (473 ml)

PruGen, Inc. Pharmaceuticals

Sulfacleanse 8/4  sodium sulfacetamide and sulfur  lotion

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 42546-175 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 80 mg  in 1 mL SULFUR (SULFUR) SULFUR 40 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Aloe   BUTYLATED HYDROXYTOLUENE   Cetyl alcohol   Disodium oleamido MEA-sulfosuccinate   EDETATE DISODIUM   GLYCERYL MONOSTEARATE   Green tea leaf   MAGNESIUM ALUMINUM SILICATE   METHYLPARABEN   PEG-100 STEARATE   PROPYLPARABEN   WATER   SODIUM COCOYL ISETHIONATE   TAURINE   SODIUM THIOSULFATE   STEARYL ALCOHOL   XANTHAN GUM

Product Characteristics Color yellow Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 42546-175-16 1 BOTTLE In 1 BOX contains a BOTTLE, PUMP 1 473 mL In 1 BOTTLE, PUMP This package is contained within the BOX (42546-175-16)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2011

Labeler - PruGen, Inc. (929922750)

Revised: 05/2011PruGen, Inc.

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