Sumaxin Cleansing Pads

SULFACETAMIDE SODIUM AND SULFUR TOPICAL HUMAN PRESCRIPTION DRUG

Sumaxin Cleansing Pads is an FDA drug label for the active ingredient SULFACETAMIDE SODIUM AND SULFUR manufactured by Medimetriks Pharmaceuticals, Inc. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231215.

Generic name
SULFACETAMIDE SODIUM AND SULFUR
Manufacturer
Medimetriks Pharmaceuticals, Inc.
Product type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Dosage form
N/A
NDC
43538-100
Application
N/A
Label effective
20231215

Indications & Usage

INDICATIONS Sumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Dosage & Administration

DOSAGE AND ADMINISTRATION Wash affected area(s) with cleansing pad once or twice daily, or as directed by your physician. Wet area(s) with water. Wet pad with a little water and work into a full lather. Cleanse area(s) with pad for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry. Discard pad. Do not flush.

Contraindications

CONTRAINDICATIONS Sumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are not to be used by patients with kidney disease.

Warnings

WARNINGS 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. 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. FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.

Adverse Reactions

ADVERSE REACTIONS Although rare, sodium sulfacetamide may cause local irritation.

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