Drugplain

Sodium Sulfacetamide 9.8 % and Sulfur 4.8 % Cleanser 98 mg/g

Sodium Sulfacetamide and Sulfur · LOTION · SOHM, Inc

No Recall HistoryCurrently in Shortage
Plain English

Sodium Sulfacetamide 9.8 % and Sulfur 4.8 % Cleanser is a lotion containing sodium sulfacetamide and sulfur at 98 mg/g, taken topical. Manufactured by SOHM, Inc.

Key Facts

Brand Name
Sodium Sulfacetamide 9.8 % and Sulfur 4.8 % Cleanser
Generic Name
Sodium Sulfacetamide and Sulfur
NDC Code (Product)
50405-852
Manufacturer
SOHM, Inc
Strength
98 mg/g
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Marketing Start
05/03/2023

Recall History

No Recall History

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 Sodium Sulfacetamide and Sulfur. It is a lotion 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 Sodium Sulfacetamide and Sulfur. There are 8 other brand versions of Sodium Sulfacetamide and Sulfur.

What is the NDC code for Sodium Sulfacetamide 9.8 % and Sulfur 4.8 % Cleanser 98 mg/g?

The NDC (National Drug Code) for Sodium Sulfacetamide 9.8 % and Sulfur 4.8 % Cleanser 98 mg/g is 50405-852, listed by SOHM, Inc.