Plexion label

Plexion

Plexion Recall

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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.

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:

structure

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.

Plexion Manufacturers

  • Brava Pharmaceuticals, Llc
    Plexion | Brava Pharmaceuticals, Llc
    No Recall

    Plexion | Brava Pharmaceuticals, Llc

    Plexion | Brava Pharmaceuticals, Llc

    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.

  • Brava Pharmaceuticals, Llc
    Plexion | Brava Pharmaceuticals, Llc
    No Recall

    Plexion | 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
    Plexion | Brava Pharmaceuticals, Llc
    No Recall

    Plexion | Brava Pharmaceuticals, Llc

    Plexion | Brava Pharmaceuticals, Llc

    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.

  • Brava Pharmaceuticals, Llc
    Plexion | Brava Pharmaceuticals, Llc
    No Recall

    Plexion | 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.