Sodium Sulfacetamide 9% and Sulfur 4.5% Cleanser
Sulfacetamide Sodium, Sulfur · Liquid · Topical
Uses
9% - SULFUR 4.5% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage and administration
Wash affected area once or twice daily, or as directed by your physician. Avoid contact with eyes or mucous membranes. 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 cleanser off sooner or using less often. See label booklet for Full Prescribing Information.
Contraindications
CONTRAINDICATIONS: SODIUM SULFACETAMIDE 9% - SULFUR 4.5% CLEANSER is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SODIUM SULFACETAMIDE 9% - SULFUR 4.5% CLEANSER is not to be used by patients with kidney disease.
Warnings
Although it is rare, sensitivity to sodium sulfacetamide 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. NOT FOR INTRAVAGINAL OR OPHTHALMIC USE. (KEEP AWAY FROM EYES). KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion contact a poison control center immediately. Keepcontainer tightly closed.
Precautions
Precaution 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 C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 9% & Sulfur 4.5% Cleanser. It is also not known whether Sodium Sulfacetamide 9% & Sulfur 4.5% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 9% & Sulfur 4.5% Cleanser 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 9% & Sulfur 4.5% Cleanser. However, small amounts of orally administered sulfonamides have milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 9% & Sulfur 4.5% Cleanser is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children under the age of 12 have not been established.
Side effects
Adverse Reaction Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects. To report a serious adverse event or obtain product information, call 1-877-250-3427.
Description
Each gram of sodium sulfacetamide 9% and sulfur 4.5% cleanser contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a cleanser containing Aloe Vera leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium laureth sulfate, Sodium Thiosulfate, Stearyl alcohol, Triacetin, Xanthan Gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8 H 9 N 2 NaO 3S·H2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: sec
How supplied
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. NOTICE: Protect from freezing and excessive heat. The product may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Keep bottle tightly closed. Occasionally, a slight discoloration of fabric may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by ordinary laundering without bleaches. This bottle is not filled to the top but does contain 16 fl oz of product as identified on the front panel of the bottle.
Label text from the FDA structured product label by Method Pharmaceuticals (revised Feb 12, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sulfacetamide Sodium in 2 products
- Sulfur in 2 products
Sodium Sulfacetamide 9% and Sulfur 4.5% Cleanser NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 72162-2250 | Sulfacetamide Sodium 90 mg/g; Sulfur 45 mg/g Liquid | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 58657-474 | Sulfacetamide Sodium 90 mg/g; Sulfur 45 mg/g Liquid | Method Pharmaceuticals | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Sodium Sulfacetamide 9% and Sulfur 4.5% Cleanser used for?
9% - SULFUR 4.5% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
What are the side effects of Sodium Sulfacetamide 9% and Sulfur 4.5% Cleanser?
Adverse Reaction Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects. To report a serious adverse event or obtain product information, call 1-877-250-3427. See the full label for the complete list.
Who makes Sodium Sulfacetamide 9% and Sulfur 4.5% Cleanser?
Sodium Sulfacetamide 9% and Sulfur 4.5% Cleanser is listed by 2 labelers in the FDA NDC directory, including Bryant Ranch Prepack, Method Pharmaceuticals.