FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. KEEP OUT OF THE 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
This product is indicated for use 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
Each gram contains 98 mg of sodium sulfacetamide and 48 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum.
Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C8H9N2NaO3S·H2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.
Sources
Plexion Manufacturers
- Brava Pharmaceuticals, Llc
- Brava Pharmaceuticals, Llc
Plexion | Brava Pharmaceuticals, Llc
Wash affected areas with this product once or twice daily or as directed by a physician. Moisten skin and cleansing cloth with water. Work cloth into full lather and massage gently into skin for 10 to 20 seconds, rinse thoroughly and pat dry. Discard cloth in refuse container. If drying occurs, it may be controlled by rinsing affected area sooner or using product less frequently.
- Brava Pharmaceuticals, Llc
- Brava Pharmaceuticals, Llc
Plexion | Brava Pharmaceuticals, Llc
Wash affected areas once or twice daily, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10 to 20 seconds, working into a full lather, rinse thoroughly and pat dry. If skin dryness occurs, it may be controlled by rinsing product off sooner or using less frequently.
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