Plexion

DRUG DESCRIPTION

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:

Plexion® (sodium sulfacetamide USP 10% and sulfur USP 5%)  Structural Formula Illustration

Each gram of Plexion® (sodium sulfacetamide USP 10% and sulfur USP 5%) Cleanser contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP in a cleanser base containing: Purified Water USP, Sodium Methyl Oleyltaurate, Sodium Cocoyl Isethionate, Disodium Oleamido MEA Sulfosuccinate, Cetyl Alcohol NF, Glyceryl Stearate (and) PEG-100 Stearate, Stearyl Alcohol NF, PEG-55 Propylene Glycol Oleate, Magnesium Aluminum Silicate, Methylparaben NF, Edetate Disodium USP, Butylated Hydroxytoluene, Sodium Thiosulfate USP, Fragrance, Xanthan Gum NF, and Propylparaben NF.

Each cloth of Plexion® (sodium sulfacetamide USP 10% and sulfur USP 5%) Cleansing Cloths is coated with a cleanser-based formulation. Each gram of this cleanser-based formulation contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP. The cleanser base consists of: Purified Water USP, Sodium Methyl Oleyltaurate, Sodium Cocoyl Isethionate, Disodium Laureth Sulfosuccinate (and) Sodium Lauryl Sulfoacetate, Disodium Oleamido MEA Sulfosuccinate, Glycerine USP, Sorbitan Monooleate NF, Glyceryl Stearate (and) PEG-100 Stearate, Stearyl Alcohol NF, Propylene Glycol (and) PEG-55 Propylene Glycol Oleate, Cetyl Alcohol NF, Edetate Disodium USP, Methylparaben NF, PEG-150 Pentaerythrityl Tetrastearate, Butylated Hydroxytoluene NF, Sodium Thiosulfate USP, Aloe Vera Gel Decolorized, Allantoin, Alpha Bisabolol Natural, Fragrance, Propylparaben NF.

Each gram of Plexion SCT® (sodium sulfacetamide USP 10% and sulfur USP 5%) contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP in a cream containing: Purified Water USP, Kaolin USP, Glyceryl Stearate (and) PEG-100 Stearate, Witch Hazel USP, Silicon Dioxide, Magnesium Aluminum Silicate, Benzyl Alcohol NF, Water (and) Propylene Glycol (and) Quillaia Saponaria Extract, Xanthan Gum NF, Sodium Thiosulfate USP, Fragrance.

Each gram of Plexion® (sodium sulfacetamide USP 10% and sulfur USP 5%) Topical Suspension contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP in a suspension containing: Purified Water USP, Propylene Glycol USP, Isopropyl Myristate NF, Light Mineral Oil NF, Polysorbate 60, Sorbitan Monostearate NF, Cetyl Alcohol NF, Hydrogenated Coco-Glycerides, Stearyl Alcohol NF, Fragrances, Benzyl Alcohol NF, Glyceryl Stearate (and) PEG-100 Stearate, Dimethicone NF, Zinc Ricinoleate, Xanthan Gum NF, Edetate Disodium USP, and Sodium Thiosulfate USP.

What are the precautions when taking sulfacetamide (Plexion)?

Before using sulfacetamide with sulfur, tell your doctor or pharmacist if you are allergic to it; or to other products containing sulfa or sulfur; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

Based on information of related drugs, this medication may pass into breast milk. Consult your doctor before breast-...

Read All Potential Precautions of Plexion »


Plexion Consumer (continued)

SIDE EFFECTS: Redness, irritation or scaling of the skin may occur. If any of these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: cracked skin.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual weakness/fatigue, dark urine, yellowing eyes or skin, other signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding.

You may be at increased risk for side effects if this medication is used on raw or broken skin. Consult your doctor for details.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using sulfacetamide with sulfur, tell your doctor or pharmacist if you are allergic to it; or to other products containing sulfa or sulfur; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

Based on information of related drugs, this medication may pass into breast milk. Consult your doctor before breast- feeding.



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