SUMADAN WASH- sulfacetamide sodium and sulfur cream SUMADAN- sulfacetamide sodium and sulfur kit

Sumadan by

Drug Labeling and Warnings

Sumadan by is a Prescription medication manufactured, distributed, or labeled by Medimetriks Pharmaceuticals Inc., IGI Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx Only

In a Moisturizing
Novasome® Vehicle

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.

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.

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 SUPPLIED

Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is available in a Net wt. 16 oz. (454 g) bottle, NDC: 43538-190-16.

Sumadan® KIT contents one unit of Sumadan® Wash, Net wt. 16 oz. (454 g) and one unit of Rehyla® Wash, 16 oz. bottle, NDC: 43538-191-16.

Sumadan® XLT contents one unit of Sumadan® Wash, Net wt. 16 oz. (454 g) bottle and one unit of Niseko® Sunscreen, 3 oz. tube, NDC: 43538-192-16.

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.

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.

SPL UNCLASSIFIED SECTION

Manufactured for:

MEDIMETRIKS
PHARMACEUTICALS, INC.

383 Route 46 West
Fairfield, NJ 07004-2402 USA

www.medimetriks.com

IP022-R3
Rev. 10/17

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 - Kit 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.

INGREDIENTS AND APPEARANCE

SUMADAN WASH 
sulfacetamide sodium and sulfur cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 43538-190
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
sulfacetamide sodium (UNII: 4NRT660KJQ) (sulfacetamide - UNII:4965G3J0F5)	sulfacetamide sodium	90 mg  in 1 g
sulfur (UNII: 70FD1KFU70) (sulfur - UNII:70FD1KFU70)	sulfur	45 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
butylated hydroxytoluene (UNII: 1P9D0Z171K)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
caprylyl glycol (UNII: 00YIU5438U)
cetyl alcohol (UNII: 936JST6JCN)
cholesterol (UNII: 97C5T2UQ7J)
dimethicone (UNII: 92RU3N3Y1O)
edetate disodium (UNII: 7FLD91C86K)
glyceryl monostearate (UNII: 230OU9XXE4)
hexylene glycol (UNII: KEH0A3F75J)
lemon oil (UNII: I9GRO824LL)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
magnesium chloride (UNII: 02F3473H9O)
magnesium nitrate (UNII: 77CBG3UN78)
methylchloroisothiazolinone (UNII: DEL7T5QRPN)
methylisothiazolinone (UNII: 229D0E1QFA)
niacinamide (UNII: 25X51I8RD4)
nonoxynol-20 (UNII: 60ZT1XYO5N)
octoxynol-5 (UNII: TJ327E1R1V)
water (UNII: 059QF0KO0R)
PEG-100 stearate (UNII: YD01N1999R)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene glycol (UNII: 6DC9Q167V3)
sodium methyl cocoyl taurate (UNII: JVL98CG53G)
sodium thiosulfate (UNII: HX1032V43M)
stearyl alcohol (UNII: 2KR89I4H1Y)
xanthan gum (UNII: TTV12P4NEE)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43538-190-16	1 in 1 CARTON	07/10/2011
1		454 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

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	Item Code (Source)	NDC: 43538-191

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43538-191-16	1 in 1 CARTON; Type 0: Not a Combination Product	08/01/2011

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfacetamide Sodium (UNII: 4NRT660KJQ) (Sulfacetamide - UNII:4965G3J0F5)	Sulfacetamide Sodium	90 mg  in 1 g
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	45 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
butylated hydroxytoluene (UNII: 1P9D0Z171K)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
caprylyl glycol (UNII: 00YIU5438U)
cetyl alcohol (UNII: 936JST6JCN)
cholesterol (UNII: 97C5T2UQ7J)
dimethicone (UNII: 92RU3N3Y1O)
disodium oleamido mipa-sulfosuccinate (UNII: 0MBZ20845F)
edetate disodium (UNII: 7FLD91C86K)
glyceryl monostearate (UNII: 230OU9XXE4)
hexylene glycol (UNII: KEH0A3F75J)
lemon oil (UNII: I9GRO824LL)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
magnesium chloride (UNII: 02F3473H9O)
magnesium nitrate (UNII: 77CBG3UN78)
methylchloroisothiazolinone (UNII: DEL7T5QRPN)
methylisothiazolinone (UNII: 229D0E1QFA)
niacinamide (UNII: 25X51I8RD4)
nonoxynol-20 (UNII: 60ZT1XYO5N)
octoxynol-5 (UNII: TJ327E1R1V)
water (UNII: 059QF0KO0R)
PEG-100 stearate (UNII: YD01N1999R)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene glycol (UNII: 6DC9Q167V3)
sodium methyl cocoyl taurate (UNII: JVL98CG53G)
sodium thiosulfate (UNII: HX1032V43M)
stearyl alcohol (UNII: 2KR89I4H1Y)
xanthan gum (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		454 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

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 
moisturizing cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	water (UNII: 059QF0KO0R)
INGR	glyceryl monostearate (UNII: 230OU9XXE4)
INGR	glycerin (UNII: PDC6A3C0OX)
INGR	cetyl alcohol (UNII: 936JST6JCN)
INGR	disodium oleamido mipa-sulfosuccinate (UNII: 0MBZ20845F)
INGR	cholesterol (UNII: 97C5T2UQ7J)
INGR	disodium laureth sulfosuccinate (UNII: D6DH1DTN7E)
INGR	helianthus annuus seed wax (UNII: 42DG15CHXV)
INGR	caprylyl glycol (UNII: 00YIU5438U)
INGR	propylene glycol (UNII: 6DC9Q167V3)
INGR	phenoxyethanol (UNII: HIE492ZZ3T)
INGR	sodium cocoyl isethionate (UNII: 518XTE8493)
INGR	cocamidopropyl betaine (UNII: 5OCF3O11KX)
INGR	sodium methyl cocoyl taurate (UNII: JVL98CG53G)
INGR	C13-14 isoparaffin (UNII: E4F12ROE70)
INGR	sodium chloride (UNII: 451W47IQ8X)
INGR	niacinamide (UNII: 25X51I8RD4)
INGR	edetate disodium (UNII: 7FLD91C86K)
INGR	hexylene glycol (UNII: KEH0A3F75J)
INGR	laureth-7 (UNII: Z95S6G8201)
INGR	chamaemelum nobile flower (UNII: O2T154T6OG)
INGR	hyaluronate sodium (UNII: YSE9PPT4TH)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		454 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

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	Business Operations
IGI Laboratories		011036910	MANUFACTURE(43538-190, 43538-191)