Sumaxin

Medimetriks Pharmaceuticals, Inc.

sumaxin (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads

FULL PRESCRIBING INFORMATION: CONTENTS*

• SUMAXIN DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS
• SUMAXIN CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Information for Patients
  • Carcinogenesis, Mutagenesis and Impairment of Fertility
  • PREGNANCY
  • NURSING MOTHERS
  • PEDIATRIC USE
• SUMAXIN ADVERSE REACTIONS
• SUMAXIN DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 60 Pad Carton
• PRINCIPAL DISPLAY PANEL - Kit Carton

FULL PRESCRIBING INFORMATION

In a vehicle containing Green Tea & Aloe

R_x Only

SUMAXIN 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 pad of Sumaxin^® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads is coated with a cleanser-based formulation. Each gram of this cleanser-based formulation contains 100 mg of Sodium Sulfacetamide and 40 mg of Sulfur. The cleanser base consists of: aloe, butylated hydroxytoluene, cetyl alcohol, disodium oleamido MEA sulfosuccinate, edetate disodium, fragrance, glycerin, glyceryl stearate/PEG-100 stearate, green tea, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium lauryl sulfoacetate, sodium thiosulfate, stearyl alcohol.

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

Sumaxin^® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

SUMAXIN CONTRAINDICATIONS

Sumaxin^® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sumaxin^® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are 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 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 Sumaxin^® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads. It is also not known whether Sumaxin^® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sumaxin^® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads 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 10% & sulfur 4%) Cleansing Pads. 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 10% & sulfur 4%) Cleansing Pads are administered to a nursing woman.

PEDIATRIC USE

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

SUMAXIN ADVERSE REACTIONS

Although rare, sodium sulfacetamide may cause local irritation.

SUMAXIN DOSAGE AND ADMINISTRATION

Wash affected area(s) with cleansing pad once or twice daily, or as directed by your physician. Wet area(s) with water. Wet pad with a little water and work into a full lather. Cleanse area(s) with pad for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry. Discard pad. Do not flush.

HOW SUPPLIED

Sumaxin^® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are available in boxes of 60 cloths (3.7 g), NDC 43538-100-60.

Store at 15°-30° C (59°-86° F).

Manufactured for:
MEDIMETRIKS
PHARMACEUTICALS, INC.

363 Route 46 West
Fairfield, NJ 07004-2402 USA

www.medimetriks.com

IP001-R3
Rev. 6/11

PRINCIPAL DISPLAY PANEL - 60 Pad Carton

NDC 43538-100-60

R_x Only
sumaxin^®
(sodium sulfacetamide 10% & sulfur 4%)
Cleansing Pads

In a vehicle containing Green Tea & Aloe

60 Cleansing Pads
Net wt. 3.7 g Each

MEDIMETRIKS
PHARMACEUTICALS, INC.

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 43538-101-60

R_x Only
sumaxin^®
(Sodium Sulfacetamide 10%
& Sulfur 4%) Cleansing Pads
CP
KIT

CONTENTS:

• 1 -Sumaxin^® (Sodium Sulfacemide 10% & Sulfur 4%)
  Cleansing Pads Carton - 60 Pads (Net wt. 3.7 g each)
• 1 -Rehyla™ Wash Moisturizing Daily Wash (16 fl. oz.)

MEDIMETRIKS
PHARMACEUTICALS, INC.