all of sudden Clenia Cream Generic Name: sulfacetamide sodium and sulfur Dosage Form: cream and wash 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. Clenia (sodium sulfacetamide 10% and sulfur 5%) Foaming Wash and Emollient Cream Rx only Clenia Cream 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 CLENIA (sodium sulfacetamide 10% and sulfur 5%) Foaming Wash contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur in a base containing Butylated Hydroxytoluene, NF, Disodium EDTA, USP, Disodium Oleamido MEA Sulfosuccinate, Fragrance, Glyceryl Stearate (and) PEG-100 Stearate, Magnesium Aluminum Silicate, NF, Methylparaben, NF, Mica, PEG-55 Propylene Glycol Oleate, Propylene Glycol, USP, Propylparaben, NF, Purified Water, USP, Silicon Dioxide, Sodium Cocyl Isethionate, Sodium Methyl Oleytaurate, Sodium Thiosulfate, USP, Stearic Acid, NF, Titanium Dioxide, Xanthan Gum, NF. Each gram of CLENIA (sodium sulfacetamide 10% and sulfur 5%0 Emollient Cream contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur in a base containing Allantoin, Disodium EDTA, USP, Emulsifying Wax, NF, Fragrance, Glyceryl Monostearate, Isopropyl Myristate, NF, Methylparaben, NF, PEG-8 Stearate, Propylene Glycol, USP, Propylparaben, NF, Purified Water, USP, Sodium Thiosulfate, USP, Stearic Acid, NF, Xanthan Gum, NF. Slideshow Acne Advice: Skin Care Solutions For Both Teens and Adults Alike Clenia Cream - Clinical Pharmacology Sodium sulfacetamide exhibits antibacterial activity. It is believed to block bacterial growth by acting as a competitive antagonist of para-aminobenzoic acid (PABA). While absorption through intact skin has not been determined for sodium sulfacetamide, it is estimated that 1% of topically applied sulfur is absorbed. Although the exact mode of the keratolytic activity of sulfur is unknown, it is reported to result from the interaction of sulfur with the cysteine content of keratinocytes. In combination with sulfacetamide, sulfur has been reported to inhibit P. acnes , thereby reducing the associated inflammation. INDICATIONS CLENIA (sodium sulfacetamide 10% and sulfur 5%) Foaming Wash and CLENIA (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. Contraindications CLENIA Foaming Wash and CLENIA Emollient Cream are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of these preparations. CLENIA Foaming Wash and CLENIA Emollient Cream are not to be used by patients with kidney disease. Warnings Although rare, hypersensitivity reactions to products containing sodium sulfacetamide may occur, including Stevens-Johnson syndrome and exfoliative dermatitis. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura, hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensivity 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. Precautions General Although the object of this therapy is to achieve desquamation without irritation, this product poses a low potential for irritation, which may include reddening and scaling of the epidermis. Uncommon adverse reactions such as dryness, erythema, itching and edema may occur. Therefore, patients should be monitored for possible local irritation or sensitization. Use of the product should be discontinued if excessive irritation develops. 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 Pregnancy Category C Animal reproduction studies have not been conducted with CLENIA (sodium sulfacetamide 10% and sulfur 5%) Foaming Wash or CLENIA (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream. It is not known whether CLENIA Foaming Wash and CLENIA Emollient Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CLENIA Foaming Wash and CLENIA Emollient Cream should be used during pregnancy only if the potential benefit outweighs the potential risk. Nursing Mothers It is not known whether sodium sulfacetamide is excreted in human milk following topical use of CLENIA Foaming Wash and CLENIA Emollient Cream. However, small amounts of orally administered sulfonamides have been detected in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when CLENIA Foaming Wash and CLENIA Emollient Cream 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, adverse reactions such as dryness, erythema, itching and edema have been reported. Clenia Cream Dosage and Administration CLENIA Foaming Wash Wash affected areas once or twice daily or as directed by a physician. Wet skin, apply liberally and massage gently into skin for 10-20 seconds working into a full later. Rinse thoroughly and pat dry. Avoid contact with eyes and mucous membranes. If drying occurs, reduce cleansing time and rinse product off sooner or use less often. CLENIA Emollient Cream Cleanse skin thoroughly before application. Apply a thin layer to affected areas 1-3 times daily or as directed by a physician. To minimize potential dryness, start with one application daily, then gradually increase to 2-3 times daily as needed or as directed by a physician. How is Clenia Cream Supplied CLENIA (sodium sulfacetamide 10% and sulfur 5%) Foaming Wash is available in 6 oz (170 g) bottles (NDC 0245-0168-06) and 12 oz (340 g) bottles (NDC 0245-0168-12). CLENIA (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream is available in 1 oz (28 g) tubes (NDC 0245-0169-01). Store at 15-25 C (59-77 F). Avoid excessive heat. Manufactured for UPSHER-SMITH LABORATORIES, INC. Minneapolis, MN 55447 by: Contract Pharmaceuticals Limited Canada Mississauga, Ontario L5N 6L6 CANADA US Patent 6,977,081 for CLENIA (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream 100556-01 Revised 0808 2004618 PRINCIPAL DISPLAY PANEL - 28 g tube label NDC 0245-0169-01 Rx only CLENIA (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream 1 oz (28 g) UPSHER-SMITH PRINCIPAL DISPLAY PANEL - 28 g tube carton NDC 0245-0169-01 Rx only CLENIA (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream 1 oz (28 g) UPSHER-SMITH PRINCIPAL DISPLAY PANEL - 3 g sample tube label NDC 0245-0169-20 Rx only CLENIA (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream 3 g (0.1 oz) UPSHER-SMITH PRINCIPAL DISPLAY PANEL - 3 g sample tube carton NDC 0245-0169-20 Rx only CLENIA (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream 20 tubes of 3 g (0.1 oz) each PROFESSIONAL SAMPLES: Not for Sale UPSHER-SMITH PRINCIPAL DISPLAY PANEL - 170 g bottle label NDC 0245-0168-06 Rx only CLENIA (sodium sulfacetamide 10% and sulfur 5%) Foaming Wash 6 oz (170 g) UPSHER-SMITH 2003765 R0505 PRINCIPAL DISPLAY PANEL - 170 g bottle carton NDC 0245-0168-06 Rx only CLENIA (sodium sulfacetamide 10% and sulfur 5%) Foaming Wash 6 oz (170 g) UPSHER-SMITH PRINCIPAL DISPLAY PANEL - 340 g bottle label NDC 0245-0168-12 Rx only CLENIA (sodium sulfacetamide 10% and sulfur 5%) Foaming Wash 12 oz (340 g) UPSHER-SMITH 2003771 R0505 PRINCIPAL DISPLAY PANEL - 340 g bottle carton NDC 0245-0168-12 Rx only CLENIA (sodium sulfacetamide 10% and sulfur 5%) Foaming Wash 12 oz (340 g) UPSHER-SMITH PRINCIPAL DISPLAY PANEL - 5 g sample bottle label NDC 0245-0168-20 Rx only CLENIA (sodium sulfacetamide 10% and sulfur 5%) Foaming Wash 5 g (0.2 oz) UPSHER-SMITH PRINCIPAL DISPLAY PANEL - 5 g sample bottle carton NDC 0245-0168-20 Rx only CLENIA (sodium sulfacetamide 10% and sulfur 5%) Foaming Wash 20 packets of 5 g (0.2 oz) each PROFESSIONAL SAMPLES: Not for Sale UPSHER-SMITH CLENIA sulfacetamide sodium and sulfur cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0245-0169 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sulfacetamide sodium (sulfacetamide) sulfacetamide 100 mg in 1 g sulfur (sulfur) sulfur 50 mg in 1 g Inactive Ingredients Ingredient Name Strength allantoin edetate disodium Glyceryl Monostearate isopropyl myristate methylparaben polyoxyl 8 stearate propylene glycol propylparaben water sodium thiosulfate stearic acid xanthan gum Packaging # Item Code Package Description 1 NDC:0245-0169-01 1 TUBE (TUBE) in 1 CARTON 1 28 g in 1 TUBE 2 NDC:0245-0169-20 1 TUBE (TUBE) in 1 CARTON 2 3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 09/01/2009 CLENIA sulfacetamide sodium and sulfur cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0245-0168 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sulfacetamide sodium (sulfacetamide) sulfacetamide 100 mg in 1 g sulfur (sulfur) sulfur 50 mg in 1 g Inactive Ingredients Ingredient Name Strength butylated hydroxytoluene edetate disodium Glyceryl Monostearate polyoxyl 100 stearate magnesium aluminum silicate methylparaben propylene glycol propylparaben water silicon dioxide sodium thiosulfate stearic acid titanium dioxide xanthan gum Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:0245-0168-06 1 BOTTLE (BOTTLE) in 1 CARTON 1 170 g in 1 BOTTLE 2 NDC:0245-0168-12 1 BOTTLE (BOTTLE) in 1 CARTON 2 340 g in 1 BOTTLE 3 NDC:0245-0168-20 20 PACKET (PACKET) in 1 CARTON 3 5 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 09/01/2009 Labeler - Upsher-Smith Laboratories, Inc (047251004) Establishment Name Address ID/FEI Operations Upsher-Smith Laboratories, Inc 047251004 ANALYSIS Establishment Name Address ID/FEI Operations Contract Pharmaceuticals Limited Canada 208761249 ANALYSIS, MANUFACTURE Establishment Name Address ID/FEI Operations Innopharm 201939910 ANALYSIS Revised: 09/2009 Upsher-Smith Laboratories, Inc Next Interactions Print this page Add to My Med List More about Clenia Emollient Cream (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 , ... +26 more 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... 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a unusual Clenia Cream for bathroom
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