feel free Rosula Cleansing Cloth Generic Name: sodium sulfacetamide and sulfur Dosage Form: cloth Side Effects Dosage Professional Interactions Reviews More Support Group Q & A 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 TM (Sodium sulfacetamide 10% and Sulfur 5%) Cleansing Cloths Rx Only Slideshow Newborn Baby Health: 8 Woes From Cradle Cap And Colic To Whooping Cough Rosula Cleansing Cloth 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. Rosula Cleansing Cloth - 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 is Rosula Cleansing Cloth 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 ROSULA sodium sulfacetamide 10% and sulfur 5% cloth Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-104 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 50 mg in 1 g Inactive Ingredients Ingredient Name Strength Butylated Hydroxytoluene Edetate Disodium Disodium Laureth Sulfosuccinate Hydrochloric Acid Methylparaben Mineral Oil Propylparaben Water Sodium Cocoyl Isethionate Sodium Thiosulfate Cetostearyl Alcohol Polysorbate 60 Peg-150 Stearate Steareth-20 Sodium Lauryl Sulfoacetate Ppg-2 Hydroxyethyl Coco/isostearamide Packaging # Item Code Package Description 1 NDC:75854-104-30 30 BOX in 1 CARTON 1 3.7 g in 1 BOX 2 NDC:75854-104-60 60 BOX in 1 CARTON 2 3.7 g in 1 BOX 3 NDC:75854-104-01 3.7 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 Labeler - Avion Pharmaceuticals, LLC (965450542) Revised: 03/2015 Avion Pharmaceuticals, LLC Next Interactions Print this page Add to My Med List More about Rosula Cleanser (sulfacetamide sodium / sulfur topical) Side Effects Dosage Information Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: topical antibiotics Consumer resources Professional resources Sodium Sulfactamide and Sulfur Wash (FDA) Other brands: Sumadan , Plexion , Sulfacleanse 8/4 , Sumaxin , ... +25 more Other Formulations Rosula Rosula NS Related treatment guides Acne Rosacea Seborrheic Dermatitis} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Topical antibiotics Related Drugs topical antibiotics mupirocin topical , erythromycin topical , Bactroban , neomycin topical , gentamicin topical , bacitracin topical Rosacea doxycycline , metronidazole topical , brimonidine topical , Lotemax , MetroGel , Vibramycin , ivermectin topical , Finacea , More... Seborrheic Dermatitis prednisone , hydrocortisone topical , ketoconazole topical , dexamethasone , Decadron , Deltasone , ciclopirox topical , More... Acne doxycycline , clindamycin topical , erythromycin topical , minocycline , tretinoin topical , tetracycline topical , dapsone topical , More... Rosula Cleanser Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } is trying
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