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%)

PLEXION CLEANSER - sulfacetamide sodium and sulfur suspension 
PLEXION SCT - sulfacetamide sodium and sulfur cream 
PLEXION CLEANSING - sulfacetamide sodium and sulfur cloth 
Medicis Pharmaceutical Corp.

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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

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:

Chemical Structure

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.

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.

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 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 - 170.3 g Carton

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

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 - 340.2 g Tottle Outsert
Principal Display Panel - 340.2 g Tottle Outsert
Principal Display Panel - 340.2 g Tottle Base Label

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

Principal Display Panel - 113.4 g Carton

PLEXION CLEANSER 
sulfacetamide sodium and sulfur   suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)99207-741
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sulfacetamide Sodium (sulfacetamide) Sulfacetamide Sodium100 mg  in 1 g
Sulfur (sulfur) Sulfur50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
water 
cetyl alcohol 
glyceryl monostearate 
PEG-100 stearate 
stearyl alcohol 
magnesium aluminum silicate 
methylparaben 
edetate disodium 
butylated hydroxytoluene 
sodium thiosulfate 
xanthan gum 
propylparaben 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
199207-741-061 TUBE In 1 CARTONcontains a TUBE
1170.3 g In 1 TUBEThis package is contained within the CARTON (99207-741-06)
299207-741-12340.2 g In 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER06/01/200003/02/2011

PLEXION SCT 
sulfacetamide sodium and sulfur   cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)99207-744
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sulfacetamide Sodium (sulfacetamide) Sulfacetamide Sodium100 mg  in 1 g
Sulfur (sulfur) Sulfur50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
water 
kaolin 
glyceryl monostearate 
PEG-100 stearate 
witch hazel 
silicon dioxide 
magnesium aluminum silicate 
benzyl alcohol 
propylene glycol 
quillaja saponaria bark 
xanthan gum 
sodium thiosulfate 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
199207-744-041 TUBE In 1 CARTONcontains a TUBE
1113.4 g In 1 TUBEThis package is contained within the CARTON (99207-744-04)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER06/01/200003/02/2011

PLEXION CLEANSING 
sulfacetamide sodium and sulfur   cloth
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)99207-745
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sulfacetamide Sodium (sulfacetamide) Sulfacetamide Sodium100 mg  in 1 g
Sulfur (sulfur) Sulfur50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
water 
disodium laureth sulfosuccinate 
sodium lauryl sulfoacetate 
glycerin 
sorbitan monooleate 
glyceryl monostearate 
PEG-100 stearate 
stearyl alcohol 
propylene glycol 
cetyl alcohol 
edetate disodium 
methylparaben 
butylated hydroxytoluene 
sodium thiosulfate 
aloe vera leaf 
allantoin 
propylparaben 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
199207-745-3030 POUCH In 1 CARTONcontains a POUCH (99207-745-01)
199207-745-013.7 g In 1 POUCHThis package is contained within the CARTON (99207-745-30)
299207-745-6060 POUCH In 1 CARTONcontains a POUCH (99207-745-01)
299207-745-013.7 g In 1 POUCHThis package is contained within the CARTON (99207-745-60)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER09/01/200503/02/2011

Labeler - Medicis Pharmaceutical Corp. (182837492)
Establishment
NameAddressID/FEIOperations
Contract Pharmaceuticals Limited248761249MANUFACTURE
Establishment
NameAddressID/FEIOperations
Tapemark006154595MANUFACTURE
Revised: 03/2011Medicis Pharmaceutical Corp.