Drugplain

Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser 9.8 mg/g

SULFACETAMIDE SODIUM, SULFUR · LIQUID · Akron Pharma Inc.

No Recall History
Plain English

Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser is a liquid containing sulfacetamide sodium, sulfur at 9.8 mg/g, taken topical. Manufactured by Akron Pharma Inc..

Key Facts

Brand Name
Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser
Generic Name
SULFACETAMIDE SODIUM, SULFUR
NDC Code (Product)
71399-0486
Manufacturer
Akron Pharma Inc.
Strength
9.8 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

anti-neutrophil cytoplasmic antibody positive vasculitis2 reports
brain stem ischaemia2 reports
diarrhoea2 reports
iiird nerve paralysis2 reports
lethargy2 reports
platelet count decreased2 reports
urticaria2 reports
weight increased2 reports
abdominal pain upper1 reports
alopecia1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE: This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Dosage & Administration

DOSAGE AND ADMINISTRATION: Wash affected areas once or twice daily, or as directed by your physician. 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 skin dryness occurs, it may be controlled by rinsing product off sooner or using less frequently.

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.

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.

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 9.8% and Sulfur 4.8% Cleanser used for?

Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser contains SULFACETAMIDE SODIUM, SULFUR. It is a liquid taken topical. Consult your doctor for specific uses.

Is Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser a controlled substance?

Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser is not classified as a controlled substance by the DEA.

What is the generic name for Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser?

The generic name for Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser is SULFACETAMIDE SODIUM, SULFUR. There are 11 other brand versions of SULFACETAMIDE SODIUM, SULFUR.

What is the NDC code for Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser 9.8 mg/g?

The NDC (National Drug Code) for Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser 9.8 mg/g is 71399-0486, listed by Akron Pharma Inc..

Product NDC

71399-0486

Package NDC

71399-0486-1

Other Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser Dosages

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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)