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SUMADAN XLT

Medimetriks Pharmaceuticals inc.

SUMADAN XLT


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

SUMADAN XLT

sulfacetamide sodium, sulfur, avobenzone, octinoxate, and octisalate KIT

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:43538-192
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43538-192-16 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2013-12-01


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