Drugplain

Sodium Sulfacetamide 9 Sulfur 4.5 Wash 9 mg/g

Sulfacetamide Sodium and Sulfur · RINSE · Acella Pharmaceuticals, LLC

No Recall History
Plain English

Sodium Sulfacetamide 9 Sulfur 4.5 Wash is a rinse containing sulfacetamide sodium and sulfur at 9 mg/g, taken topical. Manufactured by Acella Pharmaceuticals, LLC.

Key Facts

Brand Name
Sodium Sulfacetamide 9 Sulfur 4.5 Wash
Generic Name
Sulfacetamide Sodium and Sulfur
NDC Code (Product)
42192-144
Manufacturer
Acella Pharmaceuticals, LLC
Strength
9 mg/g
Dosage Form
RINSE
Route
TOPICAL
Marketing Status
Marketing Start
03/20/2013

Recall History

No Recall History

Side Effects Reported to FDA

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

chronic kidney disease3 reports
anti-neutrophil cytoplasmic antibody positive vasculitis2 reports
brain stem ischaemia2 reports
headache2 reports
iiird nerve paralysis2 reports
insomnia2 reports
abdominal pain1 reports
abdominal pain upper1 reports
abscess limb1 reports
alopecia1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS Sodium Sulfacetamide 9% - Sulfur 4.5% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Dosage & Administration

DOSAGE AND ADMINISTRATION Apply Sodium Sulfacetamide 9% - Sulfur 4.5% Wash 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 9% - Sulfur 4.5% Wash 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 9% - Sulfur 4.5% Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or ony other component of this preparation. Sodium Sulfacetamide 9% - Sulfur 4.5% Wash 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 9 Sulfur 4.5 Wash used for?

Sodium Sulfacetamide 9 Sulfur 4.5 Wash contains Sulfacetamide Sodium and Sulfur. It is a rinse taken topical. Consult your doctor for specific uses.

Is Sodium Sulfacetamide 9 Sulfur 4.5 Wash a controlled substance?

Sodium Sulfacetamide 9 Sulfur 4.5 Wash is not classified as a controlled substance by the DEA.

What is the generic name for Sodium Sulfacetamide 9 Sulfur 4.5 Wash?

The generic name for Sodium Sulfacetamide 9 Sulfur 4.5 Wash is Sulfacetamide Sodium and Sulfur. There are 10 other brand versions of Sulfacetamide Sodium and Sulfur.

What is the NDC code for Sodium Sulfacetamide 9 Sulfur 4.5 Wash 9 mg/g?

The NDC (National Drug Code) for Sodium Sulfacetamide 9 Sulfur 4.5 Wash 9 mg/g is 42192-144, listed by Acella Pharmaceuticals, LLC.