NDC Code(s) : 75854-104-30, 75854-104-60, 75854-104-01
Packager : Avion Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rosula Sodium sulfacetamide 10% and Sulfur 5% CLOTH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75854-104
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sulfacetamide Sodium(UNII: 4NRT660KJQ)
(Sulfacetamide - UNII:4965G3J0F5) 		Sulfacetamide Sodium100 mg in 1 g
Sulfur(UNII: 70FD1KFU70)
(Sulfur - UNII:70FD1KFU70) 		Sulfur50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Butylated Hydroxytoluene(UNII: 1P9D0Z171K)
Edetate Disodium(UNII: 7FLD91C86K)
Disodium Laureth Sulfosuccinate(UNII: D6DH1DTN7E)
Hydrochloric Acid(UNII: QTT17582CB)
Methylparaben(UNII: A2I8C7HI9T)
Mineral Oil(UNII: T5L8T28FGP)
Propylparaben(UNII: Z8IX2SC1OH)
Water(UNII: 059QF0KO0R)
Sodium Cocoyl Isethionate(UNII: 518XTE8493)
Sodium Thiosulfate(UNII: HX1032V43M)
Cetostearyl Alcohol(UNII: 2DMT128M1S)
Polysorbate 60(UNII: CAL22UVI4M)
Peg-150 Stearate(UNII: 7BSG7DF10Q)
Steareth-20(UNII: L0Q8IK9E08)
Sodium Lauryl Sulfoacetate(UNII: D0Y70F2B9J)
Ppg-2 Hydroxyethyl Coco/isostearamide(UNII: EK4J71ZKEQ)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:75854-104-3030 in 1 CARTON
13.7 g in 1 BOX
2NDC:75854-104-6060 in 1 CARTON
23.7 g in 1 BOX
3NDC:75854-104-013.7 g in 1 BOX
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/13/2015

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

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

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