Plexion
Sulfacetamide Sodium, Sulfur · Lotion · Topical
Uses
INDICATIONS AND USAGE: This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage and administration
DOSAGE AND ADMINISTRATION: 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.
Contraindications
CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.
Warnings
WARNINGS: 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.
Precautions
PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. General: Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Although rare, sensitivity to sodium sulfacetamide 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. If the use of this product produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. 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. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed. The object of this therapy is to achieve desquamation 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 vulgaris, but patients should be cautioned about the possibility. Information for Patients: Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. The use of this product also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop. Avoid contact with eyes, lips and mucous membranes. Drug Interactions: This product is incompatible with silver preparations. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed. Chromosomal nondisjunction has been reported in the yeast, Saccharomyces cerevisiae, following application of sodium sulfacetamide. The significance of this finding to the topical use of sodium sulfacetamide in the human is unknown. Pregnancy: Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children under the age of 12 years have not been established.
Side effects
ADVERSE REACTIONS: Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS).
Overdosage
OVERDOSAGE: The oral LD 50 of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately. Manifestations: Overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. For treatment, contact your local Poison Control Center or your doctor.
Description
DESCRIPTION: Each cloth is coated with a cleanser-based formulation. Each gram of solution contains 98 mg of sodium sulfacetamide and 48 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, phenoxyethanol, propylene glycol, purified water, sodium lauryl sulfate, sodium magnesium silicate, 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 C 8 H 9 N 2 NaO 3 S·H 2 O 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. structure.jpg
How supplied
HOW SUPPLIED: 60 count carton, NDC 57883-404-60 To report a serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: Artesa Labs, LLC 13785 Research Blvd, Suite 125 Austin, TX 78750 1800037 v1 Rev. 07/2018
Storage
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). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. NOTICE: Protect from freezing and excessive heat. The product may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Occasionally, a slight discoloration of fabric may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by ordinary laundering without bleaches.
Label text from the FDA structured product label by Brava Pharmaceuticals, LLC (revised Dec 18, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sulfacetamide Sodium in 7 products
- Sulfur in 7 products
Plexion NDC products (7)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 57883-404 | Sulfacetamide Sodium 98 mg/g; Sulfur 48 mg/g Cloth | Brava Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 24470-941 | Sulfacetamide Sodium 98 mg/g; Sulfur 48 mg/g Liquid | Cintex Services, LLC | UNAPPROVED DRUG OTHER |
| 24470-942 | Sulfur 48 mg/g; Sulfacetamide Sodium 98 mg/g Cream | Cintex Services, LLC | UNAPPROVED DRUG OTHER |
| 24470-944 | Sulfur 48 mg/g; Sulfacetamide Sodium 98 mg/g Lotion | Cintex Services, LLC | UNAPPROVED DRUG OTHER |
| 44118-701 | Sulfur 48 mg/g; Sulfacetamide Sodium 98 mg/g Cream | Eckson Labs LLC | UNAPPROVED DRUG OTHER |
| 44118-703 | Sulfur 48 mg/g; Sulfacetamide Sodium 98 mg/g Lotion | Eckson Labs LLC | UNAPPROVED DRUG OTHER |
| 44118-700 | Sulfacetamide Sodium 98 mg/g; Sulfur 48 mg/g Liquid | Eckson Labs, LLC | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Plexion used for?
INDICATIONS AND USAGE: This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
What are the side effects of Plexion?
ADVERSE REACTIONS: Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal… See the full label for the complete list.
Who makes Plexion?
Plexion is listed by 4 labelers in the FDA NDC directory, including Brava Pharmaceuticals, LLC, Cintex Services, LLC, Eckson Labs LLC, Eckson Labs, LLC.