Sumaxin Wash

DESCRIPTION: Sodium sulfacetamide is a sulfacetamide 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 Sumaxin (sodium sulfacetamide 9% and sulfur 4%) Wash contains 90mg of sodium sulfacetamide and 40 mg of sulfur in a formulation consisting of: aloe, butylated hydroxytoluene, cetyl alcohol, disodium oleamido MEA sulfosuccinate, edetate disodium, fragrance, glyceryl stearate/PEG-100 stearate, green tea, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, xanthan gum.

CLINICAL PHARMACOLOGY: The most widely accepted mechanism of action of sulfacetamides is the Woods-Fildes theory, which is based on the fact the sulfacetamides 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 uncharged. The biologial 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: Sumaxin (sodium sulfacetamide 9% and sulfur 4%) Wash is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS: Sumaxin (sodium sulfacetamide 9% and sulfur 4%) Wash are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sumaxin (sodium sulfacetamide 9% and sulfur 4%) Wash 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.

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 approriate 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 Sumaxin (sodium sulfacetamide 9% and sulfur 4%) Wash . It is also not know whether Sumaxin (sodium sulfacetamide 9% and sulfur 4%) Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sumaxin (sodium sulfacetamide 9% and sulfur 4%) Wash 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 Sumaxin (sodium sulfacetamide 9% and sulfur 4%) Wash. 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 Sumaxin (sodium sulfacetamide 9% and sulfur 4%) Wash is administered to a nursing woman.

PERIATRIC 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: Apply Sumaxin (sodium sulfacetamide 9% and sulfur 4%) Wash 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 Sumaxin (sodium sulfacetamide 9% and sulfur 4%)  Wash  sooner or using less often.

HOW SUPPLIED: Sumaxin (sodium sulfacetamide 9% and sulfur 4%) Wash is availible in 16oz. bottle, NDC 43538-130-16.

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.

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

Carton
Label

Sample

SUMAXIN  WASH sodium sulfacetamide 9%-sulfur 4% solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-130 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sulfacetamide Sodium (Sulfacetamide) Sulfacetamide Sodium 90 mg  in 1 g Sulfur (Sulfur) Sulfur 40 mg  in 1 g

Inactive Ingredients Ingredient Name Strength Aloe   Butylated hydroxytoluene   Cetyl alcohol   edetate disodium   magnesium aluminum silicate   methylparaben   propylparaben   sodium thiosulfate   stearyl alcohol   xanthan gum

Packaging # Item Code Package Description 1 NDC:43538-130-16 1 BOTTLE (BOTTLE) in 1 CARTON 1 453.5 g in 1 BOTTLE 2 NDC:43538-130-99 12 g in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved other 10/30/2009

Labeler - Medimetriks Pharmaceutical inc (019903816)

Registrant - Groupe Parima inc (252437850)

Establishment
Name	Address	ID/FEI	Operations
Groupe Parima inc		252437850	manufacture

Revised: 10/2009   Medimetriks Pharmaceutical inc