Drugplain

SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream 100 mg/g

SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream · CREAM · Method Pharmaceuticals, LLC

No Recall HistoryCurrently in Shortage
Plain English

SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream is a cream containing sodium sulfacetamide 10% and sulfur 5% emollient cream at 100 mg/g, taken topical. Manufactured by Method Pharmaceuticals, LLC.

Key Facts

Brand Name
SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream
Generic Name
SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream
NDC Code (Product)
58657-468
Manufacturer
Method Pharmaceuticals, LLC
Strength
100 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Marketing Start
05/15/2022

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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

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. 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 cautio

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.

Drug Interactions

Drug Interactions: This product is incompatible with silver preparations.

Adverse Reactions

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).

Frequently Asked Questions

What is SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream used for?

SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream contains SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream. It is a cream taken topical. Consult your doctor for specific uses.

Is SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream a controlled substance?

SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream is not classified as a controlled substance by the DEA.

What is the generic name for SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream?

The generic name for SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream is SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream. There are no other listed brand versions of SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream.

What is the NDC code for SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream 100 mg/g?

The NDC (National Drug Code) for SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream 100 mg/g is 58657-468, listed by Method Pharmaceuticals, LLC.

Product NDC

58657-468

Package NDC

58657-468-01

Other SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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