Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser
100 mg/g + 50 mg/g · Liquid
- Prescription only
- Sulfonamide Antibacterial
- Active substance
- Sodium Sulfacetamide and Sulfur
- Made by
- SOHM, Inc
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2023-04-30
Sulfonamide Antibacterial
- Sulfacetamide Sodium and Sulfur Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Sulfacetamide Sodium and Sulfur Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Sulfacetamide Sodium and Sulfur Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
From the official label · 2023-04-30 · DailyMed
How it works
From this product’s own US prescribing label.
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, sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged.
While absorption through intact skin has not been determined, sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-04-30
Do not take it if
- Sulfacetamide Sodium and Sulfur Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation.
- Sulfacetamide Sodium and Sulfur Cleanser is not to be used by patients with kidney disease.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
Use once daily or as directed by your physician. Wet skin. Apply in a film to entire face, avoiding contact with eyes or mucous membranes. Wait 10 minutes or until dry. Rinse thoroughly with water and pat dry.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Although rare, sensitivity to Sulfacetaminde Sodium 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.
- 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 Sulfacetamide Sodium 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.
- Carcinogenesis, Mutagenesis and Impairment of Fertility - Long-term studies in animals have not been performed to evaluate carcinogenic potential.
- Pregnancy:
- 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 Sulfacetamide Sodium 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.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Category C - Animal reproduction studies have not been conducted with Sulfacetamide Sodium and Sulfur lotion.
- It is also not known whether Sulfacetamide Sodium and Sulfur cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
- Sulfacetamide Sodium and Sulfur cleanser should be given to a pregnant woman only if clearly needed.
- It is not known whether sulfacetamide sodium is excreted in the human milk following topical use of Sulfacetamide Sodium and Sulfur lotion.
- 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 Sulfacetamide Sodium and Sulfur cleanser is administered to a nursing woman.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Use in children
- Safety and effectiveness in children under the age of 12 have not been established.
Quoted from the official label, section “Pediatric Use”.
Side effects
Although rare, Sulfacetamide Sodium may cause local irritation.
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
- -
- 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.
Quoted from the official label, section “Patient Counseling Information”.
What it looks like and how it is packed
- Sulfacetamide Sodium 10% and Sulfur 5% cleanser is supplied in 6 oz (170 g) bottle NDC #50405-850-01 12 oz (340 g) bottle NDC #50405-850-02
- Store at 20°-25°C (68°-77°F), excursions permitted between 15°-30°C (59°-86°F).
- Brief exposure to temperatures up to 40° (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.
- Call your doctor about side effects.
- You may report side effects to FDA at 1-800-FDA-1088.
- KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN
Quoted from the official label, section “How Supplied”.
How to store it
- Store at 20°-25°C (68°-77°F), excursions permitted between 15°-30°C (59°-86°F).
- Brief exposure to temperatures up to 40° (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.
Quoted from the official label, section “Storage and Handling”.
What is in it
- Sulfacetamide Sodium is a sulfonamide with antibacterial activity while Sulfur acts as a keratolytic agent.
- Chemically Sulfacetamide Sodium is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate.
- The structural formula is:
- Each gram of Sodium Sulfacetamide 10% and Sulfur 5% Cleanser contains 100 mg of Sodium Sulfacetamide and 50 mg of sulfur in a formulation containing:
- Aloe Vera Leaf, Butylated Hydroxytoluene, Camellia 0leifera Leaf, Cetyl Alcohol, Disodium Oleamido Monoethanolamine Sulfosuccinate, Edetate Disodium, Glycerin, Glyceryl Monostearate, Magnesium Aluminum Silicate, Methylparaben, Peg-100 Stearate, Propylparaben, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol, Water, Xanthan Gum structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (2)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 2 of 2
Details
| Made by | SOHM, Inc |
|---|---|
| Active substance | Sodium Sulfacetamide and Sulfur |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Strength | 100 mg/g + 50 mg/g |
| Form | Liquid |
| Route | Topical |
| Packs | 170 g in 1 BOTTLE · 340 g in 1 BOTTLE |
| NDC | 50405-850 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.