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 | ||||||||||||||||||||||||||||||||||||
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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