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 4.5%) Wash contains 100 mg of Sodium Sulfacetamide and 45 mg of Sulfur in a formulation containing: Aloe barbadensis (Aloe Vera) Leaf Extract, Butylated Hydroxytoluene, Camellia Oleifera (Green Tea) Leaf Extract, Cetyl Alcohol, Disodium Oleamido MEA Sulfosuccinate, Edetate Disodium, Fragrance, Glycerin, Glyceryl Monostearate, Magnesium Aluminum Silicate, Methylparaben, PEG-100 Stearate, Propylparaben, Purified Water, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol and 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 not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

INDICATIONS:

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

CONTRAINDICATIONS:

Rosula™ Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Rosula™ Wash is 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 Rosula™ Wash. It is not known whether Rosula™ Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Rosula™ 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 Rosula™ Wash. However, small amounts of orally administered sulfonamides have been reported to be excreted in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Rosula™ Wash 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 rare, sodium sulfacetamide may cause local irritation.

DOSAGE AND ADMINISTRATION:

Wash affected areas with Rosula™ Wash 1-2 times or as directed by a 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 off Rosula™ Wash sooner or using less often.

HOW SUPPLIED:

Rosula™ (Sodium Sulfacetamide 10% and Sulfur 4.5%) Wash is supplied in a 12 oz (340.2 g) bottle (NDC 75854-0105-12).For lot number and expiration date, see bottom of bottle.

STORAGE:

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Protect from freezing.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, GA 30022
1-888-61-AVION
Rev 0215-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RX OnlyNDC 75854-0105-12

Rosula TM

Wash - SSS 10-4.5
(Sodium sulfacetamide 10% and Sulfur 4.5%)
In a vehicle containing Green Tea and Aloe
12 oz

FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.

Net Wt. 12 oz (340.2 g)

Avion
DERMATOLOGY

Indications: For the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Directions: Wash affected areas with Rosula™ Wash 1-2 times or as directed by a 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 off Rosula™ Wash sooner or using less often. For external use only. See package insert for full prescribing information.

Warnings: Avoid contact with eyes, lips or other mucous membranes. Keep bottle tightly closed.

KEEP OUT OF REACH OF CHILDREN.

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

Ingredients: Each gram of Rosula™ Wash contains 100 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation containing Aloe barbadensis (Aloe Vera) Leaf Extract, Butylated Hydroxytoluene, Camellia Oleifera (Green Tea) Leaf Extract, Cetyl Alcohol, Disodium Oleamido MEA Sulfosuccinate, Edetate Disodium, Fragrance, Glycerin, Glyceryl Monostearate, Magnesium Aluminum Silicate, Methylparaben, PEG-100 Stearate, Propylparaben, Purified Water, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol and Xanthan Gum.

Storage: Store at 20° to 25°C (68°-77°F), excursions permitted between 15° and 30°C (between 59° and 86°F). [See USP, “Controlled Room Temperature.”] Protect from freezing and excessive heat.

How Supplied: Rosula™ (Sodium Sulfacetamide 10% and Sulfur 4.5%) Wash is supplied in a 12 oz (340.2 g) bottle (NDC 75854-0105-12). For lot number and expiration date, see bottom of bottle.

Manufactured for:
Avion Pharmaceuticals
Alpharetta, GA 30022
1-888-61-AVION
Rev 0215-06

375854105127