Sodium Sulfacetamide, Sulfur
sulfacetamide sodium and sulfur · Liquid · Topical
Uses
INDICATIONS: Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage and administration
DOSAGE AND ADMINISTRATION: Cleanse skin thoroughly before application. Apply a thin layer to affected areas 1-3 times daily or as directed by a physician. To minimize potential dryness, start with one application daily, then gradually increase to 2-3 times daily as needed or as directed by a physician.
Contraindications
CONTRAINDICATIONS: Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation.Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream is not to be used by patients with kidney disease.
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.
Side effects
ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.
Pregnancy
PREGNANCY: Category C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream. It is not known whether Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream should be given to a pregnant woman only if clearly needed.
Pediatric use
PEDIATRIC USE: Safety and effectiveness in children under the age of 12 have not been established.
Description
DESCRIPTION: Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Each gram of Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream contains 100 mg of Sodium Sulfacetamide, USP and 50 mg of Sulfur in a base containing BHT, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Disodium EDTA, Ethylhexyl Palmitate, Ethylparaben, Fragrance, Glyceryl Monostearate SE, Methylparaben, Phenoxyethanol, Propylene Glycol, Propylparaben, Purified Water, Sodium Thiosulfate and Xanthan Gum. Structural Formula
How supplied
HOW SUPPLIED: Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream is available in 2 oz (57 g) tubes, NDC 42192-149-02 and SSS 10% - 5% (Sodium Sulfacetamide - Sulfur) Emollient Cream in 1 oz (28 g) tubes, NDC 42192-139-01.
Storage
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]
Patient information
Information for patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.
Label text from the FDA structured product label by Acella Pharmaceuticals, LLC (revised Jul 13, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sulfacetamide Sodium in 17 products
- Sulfur in 17 products
Sodium Sulfacetamide, Sulfur NDC products (17)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 42192-139 | Sulfacetamide Sodium 100 mg/g; Sulfur 50 mg/g Cream | Acella Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 42192-149 | Sulfacetamide Sodium 100 mg/g; Sulfur 50 mg/g Cream | Acella Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 87026-205 | Sulfacetamide Sodium 98 mg/g; Sulfur 48 mg/g Liquid | Aspen Medical LLC | UNAPPROVED DRUG OTHER |
| 87026-203 | Sulfacetamide Sodium 80 mg/g; Sulfur 40 mg/g Liquid | Aspen Medical LLC | UNAPPROVED DRUG OTHER |
| 87026-202 | Sulfacetamide Sodium 100 mg/g; Sulfur 50 mg/g Liquid | Aspen Medical LLC | UNAPPROVED DRUG OTHER |
| 44523-604 | Sulfacetamide Sodium 100 mg/g; Sulfur 50 mg/g Suspension | BioComp Pharma, Inc. | UNAPPROVED DRUG OTHER |
| 44523-550 | Sulfacetamide Sodium 100 mg/g; Sulfur 20 mg/g Emulsion | BioComp Pharma, Inc. | UNAPPROVED DRUG OTHER |
| 44523-542 | Sulfacetamide Sodium 100 mg/g; Sulfur 50 mg/g Cream | BioComp Pharma, Inc. | UNAPPROVED DRUG OTHER |
| 44523-520 | Sulfacetamide Sodium 100 mg/g; Sulfur 50 mg/g Cream | BioComp Pharma, Inc. | UNAPPROVED DRUG OTHER |
| 24470-950 | Sulfacetamide Sodium 90 mg/mL; Sulfur 40 mg/mL Liquid | Cintex Services, LLC | UNAPPROVED DRUG OTHER |
| 24470-953 | Sulfacetamide Sodium 100 mg/g; Sulfur 50 mg/g Liquid | Cintex Services, LLC | UNAPPROVED DRUG OTHER |
| 24470-951 | Sulfur 40 mg/mL; Sulfacetamide Sodium 80 mg/mL Suspension | Cintex Services, LLC | UNAPPROVED DRUG OTHER |
| 52187-530 | Sulfacetamide Sodium 90 mg/mL; Sulfur 40 mg/mL Liquid | KMM Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 52187-531 | Sulfur 40 mg/mL; Sulfacetamide Sodium 80 mg/mL Suspension | KMM Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 52187-536 | Sulfacetamide Sodium 100 mg/g; Sulfur 50 mg/g Rinse | KMM Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 69367-244 | Sulfacetamide Sodium 98 mg/g; Sulfur 48 mg/g Liquid | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 69367-247 | Sulfacetamide Sodium 100 mg/g; Sulfur 50 mg/g Liquid | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Sodium Sulfacetamide, Sulfur used for?
INDICATIONS: Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
What are the side effects of Sodium Sulfacetamide, Sulfur?
ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation. See the full label for the complete list.
Who makes Sodium Sulfacetamide, Sulfur?
Sodium Sulfacetamide, Sulfur is listed by 6 labelers in the FDA NDC directory, including Acella Pharmaceuticals, LLC, Aspen Medical LLC, BioComp Pharma, Inc., Cintex Services, LLC.