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  5. Label Information: Sumaxin Cleansing Pads

FDA Label for Sumaxin Cleansing Pads

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. DESCRIPTION
    3. CLINICAL PHARMACOLOGY
    4. INDICATIONS
    5. CONTRAINDICATIONS
    6. WARNINGS
    7. GENERAL
    8. INFORMATION FOR PATIENTS
    9. CARCINOGENESIS, MUTAGENESIS AND IMPAIRMENT OF FERTILITY
    10. CATEGORY C
    11. NURSING MOTHERS
    12. PEDIATRIC USE
    13. ADVERSE REACTIONS
    14. DOSAGE AND ADMINISTRATION
    15. HOW SUPPLIED
    16. STORAGE AND HANDLING
    17. PRINCIPAL DISPLAY PANEL - 60 PAD CARTON
    18. PRINCIPAL DISPLAY PANEL - KIT CARTON

Sumaxin Cleansing Pads Product Label

The following document was submitted to the FDA by the labeler of this product Medimetriks Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



In a vehicle containing Green Tea & Aloe

Rx Only

To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc., at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured for:
MEDIMETRIKS
PHARMACEUTICALS, INC.

383 Route 46 West
Fairfield, NJ 07004-2402 USA

www.medimetriks.com

IP001-R5
Rev. 10/17


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:

Chemical Structure - sumaxin 01

Chemical Structure - sumaxin 01

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.


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.


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 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.


Adverse Reactions



Although rare, sodium sulfacetamide may cause local irritation.


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.


Storage And Handling



Store at 15°-30° C (59°-86° F).


Principal Display Panel - 60 Pad Carton



NDC 43538-100-60

Rx 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 - 60 Pad Carton - sumaxin 02

PRINCIPAL DISPLAY PANEL - 60 Pad Carton - sumaxin 02


Principal Display Panel - Kit Carton



NDC 43538-101-60

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

CONTENTS:

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