Sodium Sulfacetamide 10% and Sulfur 5% Cleanser 100 mg/g

SULFACETAMIDE SODIUM, SULFUR · LIQUID · Akron Pharma Inc.

No Recall History

Plain English

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is a liquid containing sulfacetamide sodium, sulfur at 100 mg/g, taken topical. Manufactured by Akron Pharma Inc..

Key Facts

Brand Name: Sodium Sulfacetamide 10% and Sulfur 5% Cleanser
Generic Name: SULFACETAMIDE SODIUM, SULFUR
NDC Code (Product): 71399-0488
Manufacturer: Akron Pharma Inc.
Strength: 100 mg/g
Dosage Form: LIQUID
Route: TOPICAL
Marketing Status
Marketing Start: 09/13/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective3 reports

anti-neutrophil cytoplasmic antibody positive vasculitis2 reports

brain stem ischaemia2 reports

diarrhoea2 reports

dry skin2 reports

erythema2 reports

hypersensitivity2 reports

iiird nerve paralysis2 reports

impaired quality of life2 reports

lethargy2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS SODIUM SULFACETAMIDE 10% - SULFUR 5% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Dosage & Administration

DOSAGE AND ADMINISTRATION Wash affected areas with SODIUM SULFACETAMIDE 10% - SULFUR 5% CLEANSER 1 to 2 times daily or as directed by a physician. Avoid contact with eyes or mucous membranes. 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 drying occurs, it may be controlled by rinsing cleanser off sooner or using cleanser less often.

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. 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.

Contraindications

CONTRAINDICATIONS: SODIUM SULFACETAMIDE 10% - SULFUR 5% CLEANSER is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SODIUM SULFACETAMIDE 10% - SULFUR 5% CLEANSER is not to be used by patients with kidney disease.

Adverse Reactions

ADVERSE REACTIONS Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects.

Frequently Asked Questions

What is Sodium Sulfacetamide 10% and Sulfur 5% Cleanser used for?

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser contains SULFACETAMIDE SODIUM, SULFUR. It is a liquid taken topical. Consult your doctor for specific uses.

Is Sodium Sulfacetamide 10% and Sulfur 5% Cleanser a controlled substance?

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is not classified as a controlled substance by the DEA.

What is the generic name for Sodium Sulfacetamide 10% and Sulfur 5% Cleanser?

The generic name for Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is SULFACETAMIDE SODIUM, SULFUR. There are 12 other brand versions of SULFACETAMIDE SODIUM, SULFUR.

What is the NDC code for Sodium Sulfacetamide 10% and Sulfur 5% Cleanser 100 mg/g?

The NDC (National Drug Code) for Sodium Sulfacetamide 10% and Sulfur 5% Cleanser 100 mg/g is 71399-0488, listed by Akron Pharma Inc..

Product NDC

71399-0488

Package NDC

71399-0488-6

Other Sulfacetamide Brands

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

Data from openFDA · Public domain (CC0 1.0)