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 cloth of Rosula™ Cleansing Cloths is coated with a cleanser-based formulation. Each gram of this cleanser-based formulation contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur. The cleanser base consists of: Butylated hydroxytoluene, Disodium EDTA, Disodium laureth sulfosuccinate and Disodium lauryl sulfoacetate, Emulsifying wax, Hydrochloric acid, Methyl paraben, Mineral oil, PPG-hydroxyethyl coco isostearamide, Propyl paraben, Purified water, Sodium cocoyl isethionate and Sodium thiosulfate.

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™ Cleansing Cloths are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS

Rosula™ Cleansing Cloths are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or ony other component of this preparation. Rosula™ Cleansing Cloths are not to be used by patients with kidney disease.

WARNINGS

Although rare, sensitivity to sodium sulfacetaminde 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 SECTION

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 desqamation 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 vulfaris, 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 carcinogenesis potential.

Pregnancy - Category C - Animal reproduction studies have not been conducted with Rosula™ Cleansing Cloths. It is not known whether Rosula™ Cleansing Cloths can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Rosula™ Cleansing Cloths 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™ Cleansing Cloths. 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™ Cleansing Cloths 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

Wash affected area(s) with cleansing cloth once or twice daily, or as directed by your physician. Wet affected area(s) with water. Wet cloth with a little water and work into a full lather. Cleanse affected area(s) with cloth for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry. Discard cloth. Do not flush.

HOW SUPPLIED

Rosula™ Cleansing Cloths (3.7 g each – NDC 75854-104-01) are available in boxes of 30 cloths (NDC 75854-0104-30) and boxes of 60 cloths (NDC 75854-0104-60).

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).

All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.

Manufactured For:
Avion Pharmaceuticals, LLC
Alpharetta, GA 30022
1-888-61-AVION
Rev. 0315-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RX Only     NDC 75854-0104-01

Rosula
Facial Cleansing Cloths

1 cloth
SSS 10-5
(Sodium sulfacetamide 10% and Sulfur 5%)

3.7g

Manufactured For:
Avion Pharmaceuticals, LLC
Alpharetta, GA 30022
1-888-61-AVION

Rev. 0315-01

Avion
Dermatology

Indications: For the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. See package insert for full prescribing information.

Directions: Wash affected areas with cleansing cloth once or twice daily, or as directed by your physician.
1. Wet face with water.
2. Wet cloth with a little water and work into a full lather.
3. Cleanse face with cloth for 10 - 20 seconds, avoiding eyes.
4. Rinse thoroughly and pat dry.
5. Discard cloth. Do not flush.

Warnings: For external use only. KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes.

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

Contents: Active Ingredients: Sodium sulfacetamide 10% and Sulfur 5%. Inactive Ingredients: Butylated hydroxytoluene, Disodium EDTA, Disodium laureth sulfosuccinate and Disodium lauryl sulfoacetate, Emulsifying wax, Hydrochloric acid, Methyl paraben, Mineral oil, PPG-hydroxyethyl coco isostearamide, Propyl paraben, Purified water, Sodium cocoyl isethionate and Sodium thiosulfate.

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).

375854104014

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RX Only     NDC 75854-0104-30

Rosula
Cleansing Cloths

30 Cloths
SSS 10-5
(Sodium sulfacetamide 10% and Sulfur 5%)

3.7g each

Manufactured For:
Avion Pharmaceuticals, LLC
Alpharetta, GA 30022
1-888-61-AVION

Rev. 0115-02

Avion
Dermatology

Indications: For the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. See package insert for full prescribing information.

Directions: Wash affected areas with cleansing cloth once or twice daily, or as directed by your physician.
1. Wet affected areas with water.
2. Wet cloth with a little water and work into a full lather.
3. Cleanse affected areas with cloth for 10 - 20 seconds, avoiding eyes.
4. Rinse thoroughly and pat dry.
5. Discard cloth. Do not flush.

Warnings: For external use only. KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes.

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

Contents: Active Ingredients: Sodium sulfacetamide 10% and Sulfur 5%. Inactive Ingredients:Butylated hydroxytoluene, Disodium EDTA, Disodium laureth sulfosuccinate and Disodium lauryl sulfoacetate, Emulsifying wax, Hydrochloric acid, Methyl paraben, Mineral oil, PPG-hydroxyethyl coco isostearamide, Propyl paraben, Purified water, Sodium cocoyl isethionate and Sodium thiosulfate.

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).

375854104304

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RX Only     NDC 75854-0104-60

Rosula
Cleansing Cloths

60 Cloths
SSS 10-5
(Sodium sulfacetamide 10% and Sulfur 5%)

3.7g each

Manufactured For:
Avion Pharmaceuticals, LLC
Alpharetta, GA 30022
1-888-61-AVION

Rev. 0315-01

Avion
Dermatology

Indications: For the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. See package insert for full prescribing information.

Directions: Wash affected areas with cleansing cloth once or twice daily, or as directed by your physician.
1. Wet affected areas with water.
2. Wet cloth with a little water and work into a full lather.
3. Cleanse affected areas with cloth for 10 - 20 seconds, avoiding eyes.
4. Rinse thoroughly and pat dry.
5. Discard cloth. Do not flush.

Warnings: For external use only. KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes.

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

Contents: Active Ingredients: Sodium sulfacetamide 10% and Sulfur 5%. Inactive Ingredients:Butylated hydroxytoluene, Disodium EDTA, Disodium laureth sulfosuccinate and Disodium lauryl sulfoacetate, Emulsifying wax, Hydrochloric acid, Methyl paraben, Mineral oil, PPG-hydroxyethyl coco isostearamide, Propyl paraben, Purified water, Sodium cocoyl isethionate and Sodium thiosulfate.

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).

375854104601