SUMADAN XLT- sulfacetamide sodium, sulfur, avobenzone, octinoxate, and octisalate kit
SUMADAN XLT by
Drug Labeling and Warnings
SUMADAN XLT 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
-
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
- CONTRAINDICATIONS
-
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.
- ADVERSE REACTIONS
-
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.
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - Kit Carton
NDC: 43538-192-16
Rx Only
Sumadan®
(Sodium Sulfacetamide 9% & Sulfur 4.5%)
XLTKIT 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.
-
INGREDIENTS AND APPEARANCE
SUMADAN XLT
sulfacetamide sodium, sulfur, avobenzone, octinoxate, and octisalate kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 43538-192 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 43538-192-16 1 in 1 CARTON 12/01/2013 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 creamProduct Information 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) 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) Product Characteristics Color YELLOW Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 43538-190-16 454 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 NISEKO SUNSCREEN SPF 25
avobenzone, octinoxate, and octisalate creamProduct Information Item Code (Source) NDC: 43538-290 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX) avobenzone 30 mg in 1 g octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate 75 mg in 1 g octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate 50 mg in 1 g Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) butyloctyl salicylate (UNII: 2EH13UN8D3) glyceryl stearate SE (UNII: FCZ5MH785I) isododecane (UNII: A8289P68Y2) glycerin (UNII: PDC6A3C0OX) cetostearyl alcohol (UNII: 2DMT128M1S) cetyl alcohol (UNII: 936JST6JCN) dihexadecyl phosphate (UNII: 2V6E5WN99N) ceteth-10 phosphate (UNII: 4E05O5N49G) cholesterol (UNII: 97C5T2UQ7J) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) edetate disodium (UNII: 7FLD91C86K) methylparaben (UNII: A2I8C7HI9T) phenoxyethanol (UNII: HIE492ZZ3T) xanthan gum (UNII: TTV12P4NEE) green tea leaf (UNII: W2ZU1RY8B0) C13-14 isoparaffin (UNII: E4F12ROE70) laureth-7 (UNII: Z95S6G8201) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 43538-290-03 85 g in 1 TUBE; Type 0: Not a Combination Product 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 Business Operations IGI Laboratories 011036910 MANUFACTURE(43538-192)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.