Sumadan Wash

sulfacetamide sodium and sulfur

Dosage Form: cream
Sumadan™

(Sodium Sulfacetamide 9% & Sulfur 4.5%)

WASH

Rx Only

In a Moisturizing

Novasome® Vehicle

Sumadan Wash 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 mL of Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation consisting of: butylated hydroxytoluene, C12-15 alkyl benzoate, caprylyl glycol, cetyl alcohol, cholesterol, chrysanthemum dendranthema, dimethicone, disodium oleamido MIPA sulfosuccinate, edetate disodium, ethylene brassilate, glyceryl stearate, hexylene glycol, lemon oil, magnesium aluminum silicate, magnesium chloride, magnesium nitrate, methylchloroisothiazolinone, methylisothiazolinone, niacinamide, nonoxynol-20, octoxynol-5, purified water, PEG-100 stearate, phenoxyethanol, propylene glycol, sodium cocoyl isotheionite, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, xanthan gum.

Sumadan Wash - 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

Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications

Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) 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 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 Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash. It is also not known whether Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) 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 Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) 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 Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is 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.

Sumadan Wash Dosage and Administration

Apply Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) 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 Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash sooner or using less often.

How is Sumadan Wash Supplied

Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is available in a 16 fl. oz. (473 mL) bottle, NDC 43538-190-16.

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.

Manufactured for:

MEDIMETRIKS

PHARMACEUTICALS, INC

363 Route 46 West

Fairfield, NJ 07004-2402 USA

www.medimetriks.com

IP022

Iss. 5/11

PRINCIPAL DISPLAY PANEL - 454 g Bottle Carton

NDC 43538-190-16

Rx Only

Sumadan™

(Sodium Sulfacetamide 9% & Sulfur 4.5%)

WASH

In a moisturizing

Novasome® vehicle

Net Wt. 16 oz. (454 g)

MEDIMETRIKS

PHARMACEUTICALS, INC.

PRINCIPAL DISPLAY PANEL - 454 g Bottle Carton

NDC 43538-191-16

Rx Only

Sumadan™

(Sodium Sulfacetamide 9% & Sulfur 4.5%)

KIT

CONTENTS:

1 - Sumadan™ (Sodium Sulfacetamide 9% & Sulfur 4.5%) Wash (Net Wt. 16 oz.)

1- Rehyla™ Wash Moisturizing Daily Wash (16 fl. oz.)

MEDIMETRIKS

PHARMACEUTICALS, INC.

Sumadan Wash  sulfacetamide sodium and sulfur  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43538-190 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 45 mg  in 1 g

Inactive Ingredients Ingredient Name Strength butylated hydroxytoluene   Alkyl (C12-15) Benzoate   caprylyl glycol   cetyl alcohol   cholesterol   dimethicone   edetate disodium   glyceryl monostearate   hexylene glycol   lemon oil   magnesium aluminum silicate   magnesium chloride   magnesium nitrate   methylchloroisothiazolinone   methylisothiazolinone   niacinamide   nonoxynol-20   octoxynol-5   water   PEG-100 stearate   phenoxyethanol   propylene glycol   sodium methyl cocoyl taurate   sodium thiosulfate   stearyl alcohol   xanthan gum

Product Characteristics Color YELLOW Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 43538-190-16 1 BOTTLE In 1 CARTON contains a BOTTLE, PUMP 1 454 g In 1 BOTTLE, PUMP This package is contained within the CARTON (43538-190-16)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		07/10/2011

SUMADAN  sulfacetamide sodium and sulfur  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43538-191

Packaging # NDC Package Description Multilevel Packaging 1 43538-191-16 1 KIT In 1 CARTON None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PUMP   454 g Part 2 1 BOTTLE, PUMP   454 g

Part 1 of 2 Sumadan Wash  sulfacetamide sodium and sulfur  cream

Product Information       Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sulfacetamide Sodium (Sulfacetamide) Sulfacetamide 90 mg  in 1 g Sulfur (Sulfur) Sulfur 45 mg  in 1 g

Inactive Ingredients Ingredient Name Strength butylated hydroxytoluene   Alkyl (C12-15) Benzoate   caprylyl glycol   cetyl alcohol   cholesterol   dimethicone   disodium oleamido mipa-sulfosuccinate   edetate disodium   glyceryl monostearate   hexylene glycol   lemon oil   magnesium aluminum silicate   magnesium chloride   magnesium nitrate   methylchloroisothiazolinone   methylisothiazolinone   niacinamide   nonoxynol-20   octoxynol-5   water   PEG-100 stearate   phenoxyethanol   propylene glycol   sodium methyl cocoyl taurate   sodium thiosulfate   stearyl alcohol   xanthan gum

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 1 BOTTLE In 1 CARTON contains a BOTTLE, PUMP 1 454 g In 1 BOTTLE, PUMP This package is contained within the CARTON

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 06/01/2011

Part 2 of 2 REHYLA WASH  inert  cream

Product Information       Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength No Active Ingredients Found

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

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 1 BOTTLE In 1 CARTON contains a BOTTLE, PUMP 1 454 g In 1 BOTTLE, PUMP This package is contained within the CARTON

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: 11/2011Medimetriks Pharmaceuticals Inc.

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• Acne
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