Sodium Sulfacetamide 8% and Sulfur 4% 80 mg/mL

SULFACETAMIDE SODIUM, SULFUR · SUSPENSION · Akron Pharma Inc.

No Recall History

Plain English

Sodium Sulfacetamide 8% and Sulfur 4% is a suspension containing sulfacetamide sodium, sulfur at 80 mg/mL, taken topical. Manufactured by Akron Pharma Inc..

Key Facts

Brand Name: Sodium Sulfacetamide 8% and Sulfur 4%
Generic Name: SULFACETAMIDE SODIUM, SULFUR
NDC Code (Product): 71399-0487
Manufacturer: Akron Pharma Inc.
Strength: 80 mg/mL
Dosage Form: SUSPENSION
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

iiird nerve paralysis2 reports

sleep disorder2 reports

abdominal pain upper1 reports

alopecia1 reports

chronic kidney disease1 reports

diarrhoea1 reports

diplopia1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Dosage & Administration

DOSAGE AND ADMINISTRATION Apply Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension once or twice daily to affected areas, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10-20 seconds, working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension sooner or using less often.

Warnings

WARNINGS Although rare, sensitivity to sodium sulfacetaminde 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.

Contraindications

CONTRAINDICATIONS: Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is not to be used by patients with kidney disease.

Adverse Reactions

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

Frequently Asked Questions

What is Sodium Sulfacetamide 8% and Sulfur 4% used for?

Sodium Sulfacetamide 8% and Sulfur 4% contains SULFACETAMIDE SODIUM, SULFUR. It is a suspension taken topical. Consult your doctor for specific uses.

Is Sodium Sulfacetamide 8% and Sulfur 4% a controlled substance?

Sodium Sulfacetamide 8% and Sulfur 4% is not classified as a controlled substance by the DEA.

What is the generic name for Sodium Sulfacetamide 8% and Sulfur 4%?

The generic name for Sodium Sulfacetamide 8% and Sulfur 4% is SULFACETAMIDE SODIUM, SULFUR. There are 12 other brand versions of SULFACETAMIDE SODIUM, SULFUR.

What is the NDC code for Sodium Sulfacetamide 8% and Sulfur 4% 80 mg/mL?

The NDC (National Drug Code) for Sodium Sulfacetamide 8% and Sulfur 4% 80 mg/mL is 71399-0487, listed by Akron Pharma Inc..

Product NDC

71399-0487

Package NDC

71399-0487-6

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)