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Sumadan XLT Wash

Generic name: sulfacetamide sodium, sulfur, avobenzone, octinoxate, and octisalate
Dosage form: topical wash
Drug class: Topical antibiotics

Medically reviewed by Drugs.com. Last updated on Nov 23, 2020.

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.

Rx Only

Sumadan XLT 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 XLT 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 XLT 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 XLT Wash 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.

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 - Kit Carton

NDC 43538-192-16

Rx Only
Sumadan
®
(Sodium Sulfacetamide 9% & Sulfur 4.5%)
XLT

KIT CONTENTS:

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

1 - Niseko® Sunscreen Broad Spectrum SPF 25 (Net Wt. 3 oz.)

MEDIMETRIKS
PHARMACEUTICALS, INC.

SUMADAN XLT
sulfacetamide sodium, sulfur, avobenzone, octinoxate, and octisalate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-192
Packaging
# Item Code Package Description
1 NDC:43538-192-16 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, PUMP 454 g
Part 2 1 TUBE 85 g
Part 1 of 2
SUMADAN WASH
sulfacetamide sodium and sulfur cream
Product Information
Item Code (Source) NDC: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
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 YELLOW Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:43538-190-16 454 g in 1 BOTTLE, PUMP
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
NISEKO SUNSCREEN SPF 25
avobenzone, octinoxate, and octisalate cream
Product Information
Item Code (Source) NDC:43538-290
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
avobenzone (avobenzone) avobenzone 30 mg in 1 g
octinoxate (octinoxate) octinoxate 75 mg in 1 g
octisalate (octisalate) octisalate 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
water
Alkyl (C12-15) Benzoate
butyloctyl salicylate
glyceryl stearate SE
isododecane
glycerin
cetostearyl alcohol
cetyl alcohol
dihexadecyl phosphate
ceteth-10 phosphate
cholesterol
.alpha.-tocopherol acetate
edetate disodium
methylparaben
phenoxyethanol
xanthan gum
green tea leaf
C13-14 isoparaffin
laureth-7
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:43538-290-03 85 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 11/15/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/01/2013
Labeler - Medimetriks Pharmaceuticals Inc. (019903816)
Establishment
Name Address ID/FEI Operations
IGI Laboratories 011036910 MANUFACTURE(43538-192)
Medimetriks Pharmaceuticals Inc.