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Rosula

Generic Name: sodium sulfacetamide and sulfur
Dosage Form: aerosol, foam

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.

Rosula®
(Sodium Sulfacetamide 10% and Sulfar 4%)

FOR EXTERNAL USE ONLY

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:

Each gram of Rosula (sodium sulfacetamide 10% and sulfur 4%) Foam contains 100 mg of sodium sulfacetamide and 40 mg of sulfur in an aqueous based foam vehicle containing cetyl alcohol NF, stearyl alcohol NF, polysorbate 60, methylparaben NF, propylparaben NF, propylene glycol NF, lactic acid USR purified water USR Also contains: Propellant HFA-134A (1,1,1,2- tetrafluoroethane).

CLINICAL PHARMACOLOGY

Sodium sulfacetamide exhibits antibacterial activity. 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 mechanism of the keratolytic activity of sulfur is unknown, but it is reported to result from the interaction of sulfur with the cysteine content of keratinocytes. Furthermore, in combination with sulfacetamide, sulfur has been reported to inhibit the growth of Propionibactehum acnes, thereby adding to the product's antibacterial activity and reducing associated inflammation.

INDICATIONS

Rosula® Foam is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS

Rosula® Foam is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Rosula® Foam is not to be used by patients with kidney disease.

WARNINGS

Although rare, severe hypersensitivity reactions to sulfonamides include Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. At the first sign of hypersensitivity or skin rash, discontinue use of this preparation. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120°F (49°C).

PRECAUTIONS

General

The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the skin. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. 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.

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 Rosula® Foam. It is also not known whether Rosula® Foam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Rosula® Foam 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 Rosula® Foam. 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 Rosula® Foam is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children under the age of 12 have not been established.

Adverse Reactions

Although infrequent, sodium sulfacetamide may cause local irritation.

DOSAGE AND ADMINISTRATION

Wash affected areas before use, 1 to 2 times daily as directed by physician. Before each use, shake can vigorously, then gently tap the bottom of the can on a firm surface or in palm of other hand. Tap can 1-2 times, thenshake and tap again.

Invert can so nozzle points down. (Dispensing with the can held upright will cause a loss of the propellant and can affect product delivery.) Depress the actuator and dispense a small amount of foam (not more than a dollop the size of a golf ball).

Apply foam to the affected areas.

Avoid contact with the eyes.

WASH-OFF APPLICATION:

Massage the dispensed foam into the affected areas and wait 1 to 2 minutes. Rinse thoroughly with water and pat dry. Treat the affected area 1 to 2 times daily, as directed by a physician.

LEAVE-ON APPLICATION:

Massage the foam into the affected areas 1 to 2 times daily, as directed by a physician.

Wipe off any excess foam from actuator after use.

HOW SUPPLIED

Rosula® Foam is supplied in a 100 g, aluminum can: NDC 10337-669-99

CAUTION: Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).

Store between 68° and 77°F (20° and 25°C).

Protect from freezing.

Store upright.

Mfd. for: PharmaDerm®
     A division of Nycomed US Inc.
     Melville, NY 11747 USA
     www.pharmaderm.com

Mfd. by: Sciarra Laboratories Inc.
     485-09 South Broadway
     Hicksville, NY 11801

IF8668
R10/09

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 100 g LABEL

NDC 10337-669-99

PharmaDerm®

Rx only

Rosula®

(Sodium Sulfacetamide 10% and Sulfur 4%)

FOAM

FOR DERMATOLOGIC USE ONLY.

NOT FOR OPHTHALMIC USE.

100 g

Rosula 
sodium sulfacetamide and sulfur aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10337-669
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 40 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
cetyl alcohol  
stearyl alcohol  
polysorbate 60  
methylparaben  
propylparaben  
propylene glycol  
lactic acid  
water  
Packaging
# Item Code Package Description
1 NDC:10337-669-99 1 CAN (1 CAN) in 1 CARTON
1 100 g in 1 CAN
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/03/2010
Labeler - PharmaDerm, A division of Nycomed US Inc. (043838424)
Establishment
Name Address ID/FEI Operations
Sciarra Laboratories Inc. 824900369 MANUFACTURE, PACK, ANALYSIS
Revised: 08/2010
 
PharmaDerm, A division of Nycomed US Inc.
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