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Sumadan XLT Wash

Generic Name: sulfacetamide sodium, sulfur, avobenzone, octinoxate, and octisalate
Dosage Form: topical wash

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.

SUMADAN® XLT

Rx Only
Sumadan
®
(Sodium Sulfacetamide 9% & Sulfur 4.5%)
WASH
In a Moisturizing
Novasome® Vehicle

INGREDIENTS

Each gram of SUMADAN® 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.

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Keep out of reach of children. Keep bottle tightly closed.

niseko
SUNSCREEN
Broad Spectrum SPF 25

ACTIVE INGREDIENTS

Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5.0%.

INACTIVE INGREDIENTS

Purified Water, Cyclomethicone, C12-15 Alkyl Lactate, Butyloctyl Salicylate, Glyceryl Stearate SE, Isododecane, Glycerin, Cetearyl Alcohol, Butylene/Ethylene/Propylene Copolymer, Polyacrylamide, Cetyl Alcohol, Dicetyl Phosphate, Ceteth-10 Phosphate, Cholesterol, Tocopheryl Acetate, Edetate Disodium, Methylparaben, Phenoxyethanol, Xanthan Gum, Camellia Sinensis Leaf (Green Tea) Extract, Camellia Sinensis Leaf (White Tea) Extract, C13-C14 Isoparaffin, Laureth-7.

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.

For external use only. Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Manufactured for:
Medimetriks Pharmaceuticals, Inc., 383 Route 46 West, Fairfield, NJ 07004-2402 USA
www.medimetriks.com • MADE IN USA

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 43538-192-16

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

KIT CONTENTS:
1 - Sumadan® (Sodium Sulfacemide 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  
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)
Revised: 11/2013
 
Medimetriks Pharmaceuticals Inc.



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