Sumaxin®

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.

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.

Although rare, sodium sulfacetamide may cause local irritation.

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

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.

In a vehicle containing Green Tea & Aloe

R_x Only

Store at 15°-30° C (59°-86° F).

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.

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.

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.

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

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

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.

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.

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.

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.

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.

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

In a vehicle containing Green Tea & Aloe

R_x Only

Store at 15°-30° C (59°-86° F).

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.

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.

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.

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.

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

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

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

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.

Although rare, sodium sulfacetamide may cause local irritation.

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.

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.

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.

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.

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.

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.

Long-term studies in animals have not been performed to evaluate carcinogenic potential.