Plexion
Generic Formulation: SULFACETAMIDE SODIUM, SULFUR
Regulatory Registrant: Cintex Services, LLC
Related NDC Products
| NDC Code | Dosage Form | Route | Category |
|---|---|---|---|
| 44118-700 | LIQUID | TOPICAL | UNAPPROVED DRUG OTHER |
| 44118-701 | CREAM | TOPICAL | UNAPPROVED DRUG OTHER |
| 44118-703 | LOTION | TOPICAL | UNAPPROVED DRUG OTHER |
| 44118-712 | SHAMPOO | TOPICAL | UNAPPROVED DRUG OTHER |
| 57883-404 | CLOTH | TOPICAL | UNAPPROVED DRUG OTHER |
Indications & Usage
INDICATIONS: This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage & Administration
DOSAGE AND ADMINISTRATION: Cleanse affected areas. Apply a thin layer to the affected areas with light massaging, 1 to 3 times daily or as directed by a physician.
Warnings & Precautions
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 REACH OF CHILDREN.
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 ).
Storage & Handling
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. Keep bottle tightly closed. 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.