FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Clenia Manufacturers
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Upsher-smith Laboratories, Inc
Clenia | Upsher-smith Laboratories, Inc
CLENIA® Foaming WashWash 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 CreamCleanse 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.
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