Plexion

sulfacetamide sodium and sulfur

Dosage Form: cream, cloth, suspension
Plexion®

(sodium sulfacetamide 10% and sulfur 5%)

Cleanser


Plexion®

(sodium sulfacetamide 10% and sulfur 5%)

Cleansing Cloths


Plexion TS®

(sodium sulfacetamide 10% and sulfur 5%)

Topical Suspension


Plexion SCT®

(sodium sulfacetamide 10% and sulfur 5%)

Rx Only

Plexion 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 gram of Plexion® (sodium sulfacetamide USP 10% and sulfur USP 5%) Cleanser contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP in a cleanser base containing: Purified Water USP, Sodium Methyl Oleoyl Taurate, Sodium Cocoyl Isethionate, Disodium Oleamido MEA Sulfosuccinate, Cetyl Alcohol NF, Glyceryl Stearate (and) PEG-100 Stearate, Stearyl Alcohol NF, PEG-55 Propylene Glycol Oleate, Magnesium Aluminum Silicate, Methylparaben NF, Edetate Disodium USP, Butylated Hydroxytoluene, Sodium Thiosulfate USP, Fragrance, Xanthan Gum NF, and Propylparaben NF.

Each cloth of Plexion® (sodium sulfacetamide USP 10% and sulfur USP 5%) Cleansing Cloths is coated with a cleanser-based formulation. Each gram of this cleanser-based formulation contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP. The cleanser base consists of: Purified Water USP, Sodium Methyl Oleoyl Taurate, Sodium Cocoyl Isethionate, Disodium Laureth Sulfosuccinate (and) Sodium Lauryl Sulfoacetate, Disodium Oleamido MEA Sulfosuccinate, Glycerin USP, Sorbitan Monooleate NF, Glyceryl Stearate (and) PEG-100 Stearate, Stearyl Alcohol NF, Propylene Glycol (and) PEG-55 Propylene Glycol Oleate, Cetyl Alcohol NF, Edetate Disodium USP, Methylparaben NF, PEG-150 Pentaerythrityl Tetrastearate, Butylated Hydroxytoluene NF, Sodium Thiosulfate USP, Aloe Vera Gel Decolorized, Allantoin, Alpha Bisabolol Natural, Fragrance, Propylparaben NF.

Each gram of Plexion SCT® (sodium sulfacetamide USP 10% and sulfur USP 5%) contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP in a cream containing: Purified Water USP, Kaolin USP, Glyceryl Stearate (and) PEG-100 Stearate, Witch Hazel USP, Silicon Dioxide, Magnesium Aluminum Silicate, Benzyl Alcohol NF, Water (and) Propylene Glycol (and) Quillaia Saponaria Extract, Xanthan Gum NF, Sodium Thiosulfate USP, Fragrance.

Each gram of Plexion® (sodium sulfacetamide USP 10% and sulfur USP 5%) Topical Suspension contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP in a suspension containing: Purified Water USP, Propylene Glycol USP, Isopropyl Myristate NF, Light Mineral Oil NF, Polysorbate 60, Sorbitan Monostearate NF, Cetyl Alcohol NF, Hydrogenated Coco-Glycerides, Stearyl Alcohol NF, Fragrances, Benzyl Alcohol NF, Glyceryl Stearate (and) PEG-100 Stearate, Dimethicone NF, Zinc Ricinoleate, Xanthan Gum NF, Edetate Disodium USP, and Sodium Thiosulfate USP.

Plexion - 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

Plexion® Cleanser, Plexion® Cleansing Cloths, Plexion SCT® and Plexion TS® are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications

Plexion® Cleanser, Plexion® Cleansing Cloths, Plexion SCT® and Plexion TS® are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. These Plexion brand products are 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 Plexion® Cleanser, Plexion® Cleansing Cloths, Plexion SCT® or Plexion TS®. It is also not known whether these Plexion brand products can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. These Plexion brand products 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 Plexion Cleanser, Plexion Cleansing Cloths, Plexion SCT or Plexion TS. 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 these Plexion brand products are 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.

Plexion Dosage and Administration

Plexion® Cleanser

Wash affected areas once or twice daily, or as directed by your physician. Avoid contact with eyes or mucous membranes. 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 cleanser off sooner or using less often.

Plexion® Cleansing Cloths

Wash affected areas with cleansing cloth once or twice daily, or as directed by your physician. Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10–20 seconds avoiding eyes. Rinse thoroughly and pat dry. Throw away cloth. Do not flush.

Plexion SCT®

Use once daily or as directed by your physician. Wet skin. Apply in a film to entire face, avoiding contact with eyes or mucous membranes. Wait 10 minutes or until dry. Rinse thoroughly with water and pat dry.

Plexion TS®

Cleanse affected areas. Apply a thin film of Plexion TS to affected areas 1 to 3 times daily, or as directed by your physician.

How is Plexion Supplied

Plexion® (sodium sulfacetamide 10% and sulfur 5%) Cleanser is available in 6 oz. (170.3 g) tube (NDC 99207-741-06) and 12 oz. (340.2 g) bottle (NDC 99207-741-12). Plexion® (sodium sulfacetamide 10% and sulfur 5%) Cleansing Cloths are available in boxes of 30 cloths (3.7 g) (NDC 99207-745-30) and boxes of 60 cloths (3.7 g) (NDC 99207-745-60). Plexion SCT® (sodium sulfacetamide 10% and sulfur 5%) is available in a 4 oz. tube (NDC 99207-744-04). Plexion® (sodium sulfacetamide 10% and sulfur 5%) Topical Suspension is available in 30 g tube (NDC 99207-743-30).

Store at 15°–25°C (59°–77°F).

Manufactured for:

Medicis, The Dermatology Company

Scottsdale, AZ 85258

Plexion® Cleanser, Plexion TS®, Plexion SCT® are manufactured by:

Contract Pharmaceuticals Limited

Mississauga, Ontario CANADA L5N 6L6

Made in Canada

Plexion® Cleansing Cloths are manufactured by:

Tapemark

West St. Paul, MN 55118

Prescribing information as of March 2007

Plexion SCT®: U.S. Pat. 6,514,489; 6,787,160; 6,855,342

& 6,955,825

Plexion TS®: U.S. Pat. 6,514,489

Plexion® Cleanser: U.S. Pat. 6,905,675

Plexion® Cleansing Cloths: U.S. Pat. 6,905,675

& Patents Pending

74530-08G

PRINCIPAL DISPLAY PANEL - 170.3 g Carton

NDC 99207-741-06

Rx Only

Plexion®

(sodium sulfacetamide 10% and sulfur 5%)

Cleanser

6 oz. (170.3 g)

by MEDICIS,

The Dermatology Company®

www.Plexion.com

PRINCIPAL DISPLAY PANEL - 340.2 g Tottle

NDC 99207-741-12

Rx Only

Plexion®

(sodium sulfacetamide 10% and sulfur 5%)

Cleanser

12 oz. (340.2 g)

by MEDICIS,

The Dermatology Company®

www.Plexion.com

Principal Display Panel - 340.2 g Tottle Outsert and Base Label

Pull Down

Plexion®

(sodium sulfacetamide 10% and sulfur 5%)

Cleanser

Manufactured for:

MEDICIS, The Dermatology Company®

Scottsdale, AZ 85258

by: Contract

Pharmaceuticals

Limited

Mississauga,

Ontario CANADA

L5N 6L6

74112-08D

PRINCIPAL DISPLAY PANEL - 113.4 g Carton

NDC 99207-744-04

Rx Only

Plexion SCT®

(sodium sulfacetamide 10% and sulfur 5%)

4 oz. (113.4 g)

by Medicis,

The Dermatology Company

Plexion CLEANSER  sulfacetamide sodium and sulfur  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 99207-741 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sulfacetamide Sodium (sulfacetamide) Sulfacetamide Sodium 100 mg  in 1 g Sulfur (sulfur) Sulfur 50 mg  in 1 g

Inactive Ingredients Ingredient Name Strength water   cetyl alcohol   glyceryl monostearate   polyoxyl 100 stearate   stearyl alcohol   magnesium aluminum silicate   methylparaben   edetate disodium   butylated hydroxytoluene   sodium thiosulfate   xanthan gum   propylparaben

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 99207-741-06 1 TUBE In 1 CARTON contains a TUBE 1 170.3 g In 1 TUBE This package is contained within the CARTON (99207-741-06) 2 99207-741-12 340.2 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		06/01/2000

Plexion SCT  sulfacetamide sodium and sulfur  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 99207-744 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sulfacetamide Sodium (sulfacetamide) Sulfacetamide Sodium 100 mg  in 1 g Sulfur (sulfur) Sulfur 50 mg  in 1 g

Inactive Ingredients Ingredient Name Strength water   kaolin   glyceryl monostearate   polyoxyl 100 stearate   witch hazel   silicon dioxide   magnesium aluminum silicate   benzyl alcohol   propylene glycol   quillaja saponaria extract   xanthan gum   sodium thiosulfate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 99207-744-04 1 TUBE In 1 CARTON contains a TUBE 1 113.4 g In 1 TUBE This package is contained within the CARTON (99207-744-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		06/01/2000

Plexion CLEANSING  sulfacetamide sodium and sulfur  cloth

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 99207-745 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sulfacetamide Sodium (sulfacetamide) Sulfacetamide Sodium 100 mg  in 1 g Sulfur (sulfur) Sulfur 50 mg  in 1 g

Inactive Ingredients Ingredient Name Strength water   disodium laureth sulfosuccinate   sodium lauryl sulfoacetate   glycerin   sorbitan monooleate   glyceryl monostearate   polyoxyl 100 stearate   stearyl alcohol   propylene glycol   cetyl alcohol   edetate disodium   methylparaben   butylated hydroxytoluene   sodium thiosulfate   aloe vera leaf   allantoin   propylparaben

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 99207-745-30 30 POUCH In 1 CARTON contains a POUCH (99207-745-01) 1 99207-745-01 3.7 g In 1 POUCH This package is contained within the CARTON (99207-745-30) 2 99207-745-60 60 POUCH In 1 CARTON contains a POUCH (99207-745-01) 2 99207-745-01 3.7 g In 1 POUCH This package is contained within the CARTON (99207-745-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		09/01/2005

Labeler - Medicis Pharmaceutical Corp. (182837492)

Establishment
Name	Address	ID/FEI	Operations
Contract Pharmaceuticals Limited		248761249	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Tapemark		006154595	MANUFACTURE

Revised: 10/2009Medicis Pharmaceutical Corp.

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