DailyMed Label: Sodium Sulfacetamide 8% and Sulfur 4%

DailyMed Label: Sodium Sulfacetamide 8% and Sulfur 4%

2024

DailyMed Prescription

Sodium Sulfacetamide 8% and Sulfur 4%

SULFACETAMIDE SODIUM, SULFUR

Oncor Pharmaceuticals

NDC: 83720-532

NDC: 83720-532

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 8% and Sulfur 4% Topical Suspension contains 80 mg of Sodium Sulfacetamide and 40 mg of Sulfur in a formulation containing Aloe Vera leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, Green Tea Extract, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium laureth sulfate, Sodium Thiosulfate, Stearyl alcohol, Triacetin, Xanthan gum. Structure

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

Apply Sodium Sulfacetamide 8% and 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% and Sulfur 4% Topical Suspension sooner or using less often.

Sodium Sulfacetamide 8% and 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% and Sulfur 4% Topical Suspension is not to be used by patients with kidney disease.

GENERAL If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. 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. CARCINOGENESIS, MUTAGENESIS AND IMPAIRMENT OF FERTILITY Long-term studies in animals have not been performed to evaluate carcinogenic potential. PREGNANCY Category CAnimal reproduction studies have not been conducted with Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension. It is not known whether Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension should be given to a pregnant woman only if clearly needed. NURSING MOTHERS It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 8% and Sulfur 4% Topica Suspension is administered to a nursing woman. PEDIATRIC USE Safety and effectiveness in children under the age of 12 have not been established.

Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects.

Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension is available in 6 fl oz (177 mL) bottles, NDC 83720-532-06 12 fl oz (354 mL) bottles NDC 83720-532-12 16 fl oz (473 mL) bottles NDC 83729-532-16. Storage: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Protect from freezing. In case of accidental ingestion contact a poison control center immediately. Keep container tightly closed. You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7900 or FDA at 1-800-FDA-1088. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Shake well before use.

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

ONCOR PHARMACEUTICALS NDC 83720-532-16 Sodium Sulfacetamide & Sulfur Sodium Sulfacetamide 8% Sulfur 4% 8% / 4% Topical Suspension  In A Vehical Containing Green Tea And Aloe Rx Only NET WT. 16 fl. OZ. (473 mL) Label