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Sumaxin Cleansing Pads

Generic Name: sulfacetamide sodium and sulfur
Dosage Form: cloth

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

In a vehicle containing Green Tea & Aloe

Rx Only

Sumaxin Cleansing Pads 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.

Sumaxin Cleansing Pads - 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.

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.

Adverse Reactions

Although rare, sodium sulfacetamide may cause local irritation.

Sumaxin Cleansing Pads 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 is Sumaxin Cleansing Pads 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

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 - Kit Carton

NDC 43538-101-60

Rx 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.

SUMAXIN   CLEANSING PADS
sulfacetamide sodium and sulfur cloth
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-100
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sulfacetamide sodium (sulfacetamide) sulfacetamide sodium 100 mg  in 1 g
Sulfur (sulfur) Sulfur 40 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
aloe  
butylated hydroxytoluene  
cetyl alcohol  
disodium oleamido MEA-sulfosuccinate  
edetate disodium  
glycerin  
green tea leaf  
methylparaben  
propylparaben  
water  
sodium cocoyl isethionate  
sodium lauryl sulfoacetate  
sodium thiosulfate  
stearyl alcohol  
Packaging
# Item Code Package Description
1 NDC:43538-100-60 60 PACKET (PACKET) in 1 CARTON
1 3.7 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/01/2009
SUMAXIN CP 
sulfacetamide sodium and sulfur kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-101
Packaging
# Item Code Package Description
1 NDC:43538-101-60 1 KIT (KIT) in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 60 PACKET 222 g
Part 2 1 BOTTLE, PUMP 454 g
Part 1 of 2
SUMAXIN   CLEANSING PADS
sulfacetamide sodium and sulfur cloth
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sulfacetamide sodium (sulfacetamide) sulfacetamide sodium 100 mg  in 1 g
sulfur (sulfur) sulfur 40 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
aloe  
butylated hydroxytoluene  
cetyl alcohol  
disodium oleamido MEA-sulfosuccinate  
edetate disodium  
glycerin  
green tea leaf  
methylparaben  
propylparaben  
water  
sodium cocoyl isethionate  
sodium lauryl sulfoacetate  
sodium thiosulfate  
stearyl alcohol  
Packaging
# Item Code Package Description
1 60 PACKET (PACKET ) in 1 CARTON
1 3.7 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/2009
Part 2 of 2
REHYLA WASH 
inert cream
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
water  
glyceryl monostearate  
glycerin  
cetyl alcohol  
disodium oleamido mipa-sulfosuccinate  
cholesterol  
disodium laureth sulfosuccinate  
helianthus annuus seed wax  
caprylyl glycol  
propylene glycol  
phenoxyethanol  
sodium cocoyl isethionate  
cocamidopropyl betaine  
sodium methyl cocoyl taurate  
C13-14 isoparaffin  
sodium chloride  
niacinamide  
edetate disodium  
hexylene glycol  
laureth-7  
chamaemelum nobile flower  
hyaluronate sodium  
Packaging
# Item Code Package Description
1 1 BOTTLE, PUMP (BOTTLE) in 1 CARTON
1 454 g in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 08/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 08/01/2011
Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)
Establishment
Name Address ID/FEI Operations
IGI Laboratories 011036910 MANUFACTURE
Revised: 12/2011
 
Medimetriks Pharmaceuticals, Inc.

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