Sodium Sulfacetamide 100 mg/mL Liquid, 354.8 mL
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Sulfonamide Antibacterial class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
This is a topical liquid containing sodium sulfacetamide at a concentration of 100 mg/mL. Sulfacetamide is a sulfonamide antibiotic typically used in topical preparations for bacterial skin infections and certain inflammatory skin conditions. This product is marketed without an approved FDA application. It is dispensed by prescription and applied directly to the skin or affected area.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with sodium sulfacetamide — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII 5OCF3O11KX
A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
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UNII 8NLQ36F6MM
Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII FCZ5MH785I
A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII 8L4OOQ76AM
A waxy compound made from polyethylene glycol and stearic acid that acts as an emulsifier and thickener. It helps blend oil and water-based ingredients together and gives the medicine its proper texture and consistency.
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UNII GO50W2HWO8
A synthetic liquid made from plant oils and polyethylene glycol. It works as a solvent and emulsifier to help dissolve and mix active ingredients evenly throughout the medicine.
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UNII 4Y0E651N0F
A plant-derived emulsifier made from almond oil and polyethylene glycol. It helps mix oil and water-based ingredients together and improves how the medicine dissolves and is absorbed in the body.
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UNII CAL22UVI4M
A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII HX1032V43M
Sodium thiosulfate is a salt compound used in medicines as a buffer and pH regulator. It helps stabilize the medication and may also serve as a preservative or antioxidant to maintain product quality.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
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UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
14 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sodium Sulfacetamide 100 mg/g 58657-0477-06 | Method | 177 g | $0.114 | — | Availability likely | — |
| Sodium Sulfacetamide 100 mg/mL 42192-0129-16 | Acella | 480 ml | $0.240 | — | Availability likely | — |
| OVACE Plus 100 mg/mL 00178-0490-04 | Mission | 10 tubes | — | — | FDA listed | — |
| Ovace 100 mg/mL 00178-0499-06 | Mission | 180 ml | — | — | FDA listed | — |
| Ovace Plus 100 mg/mL 00178-0630-16 | Mission | 473 ml | — | — | FDA listed | — |
| Sodium Sulfacetamide 100 mg/mLthis 16477-0410-12 | Laser | 354.8 ml | — | — | FDA listed | — |
| Sulfacetamide Sodium 100 mg/mL 24470-0935-12 | Cintex | 355 ml | — | — | FDA listed | — |
| Sulfacetamide Sodium 100 mg/mL 24470-0937-06 | Cintex | 177 ml | — | — | FDA listed | — |
| Sulfacetamide Sodium 100 mg/mL 44523-0568-12 | BioComp | 355 ml | — | — | FDA listed | — |
| Sodium Sulfacetamide 100 mg/mL 44523-0606-12 | BioComp | 355 ml | — | — | FDA listed | — |
| Sodium Sulfacetamide 100 mg/mL 44523-0613-06 | BioComp | 177 ml | — | — | FDA listed | — |
| Sodium Sulfacetamide 100 mg/g 63629-9262-01 | Bryant | 177 g | — | — | FDA listed | — |
| Sodium Sulfacetamide 100 mg/g 63629-9263-01 | Bryant | 355 g | — | — | FDA listed | — |
| Sodium Sulfacetamide 100 mg/g 63629-9264-01 | Bryant | 480 g | — | — | FDA listed | — |
| Sodium Sulfacetamide 100 mg/mL 71399-0480-02 | Akron | 360 ml | — | — | FDA listed | — |
| Sodium Sulfacetamide 100 mg/g 72162-1665-02 | Bryant | 355 g | — | — | FDA listed | — |
| Sodium Sulfacetamide 10% wash 100 mg/mL 83720-0543-16 | Oncor | 473 ml | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 16477-0410-06 | 177 mL in 1 BOTTLE (16477-410-06) | 2021-03-17 | Active |
| 16477-0410-12 You're viewing this | 354.8 mL in 1 BOTTLE (16477-410-12) | 2021-03-17 | Active |
Pack size FAQ
What quantity is in NDC 16477-0410-12?
What is the difference between NDC 16477-0410-12 and NDC 16477-0410-06?
What NDC number is used to bill for this package of Sodium Sulfacetamide 100 mg/mL Liquid?
🧭 About this NDC listing & data coverage
Listed without an FDA application
This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Is this NDC FDA-approved?
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
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Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE: Sodium Sulfacetamide 10% Wash is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: Seborrheic dermatits including seborrhea sica - Sodium Sulfacetamide 10% Wash: Wash affected areas twice daily (morning and evening), or as directed by your phyiscian. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, message gently into skin working into a full lather, rinse thoroughly/pat dry and repeat after 10 to 20 seconds.
Rinsing with plain water will remove any excess medication. Repeat application as described for eight to ten days. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently.
Regular shampooing following Sodium Sulfacetamide 10% Wash is not necessary but the hair should be shampooed at least once a week. As the condition subsides, the interval between applications may be lengthened. Applications once or twice a week may prevent recurrence.
Should the condition recur after stopping therapy, the application of Sodium Sulfacetamide 10% Wash should be reinitiated as at the beginning of treatment. Secondary Cutaneous Bacterial Infections - 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. Rinsing with plain water will remove any excess medication.
Repeat application as described for eight to ten days. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less often.
⛔ Contraindications ▾
CONTRAINDICATIONS: Sodium Sulfacetamide 10% Wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.
⚠️ 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 THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
🤒 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 ).
🔄 Drug Interactions ▾
Drug Interactions: Sodium Sulfacetamide 10% Wash is incompatible with silver preparations.
🤰 Pregnancy ▾
Pregnancy: Category C: Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% Wash. It is also not known whether Sodium Sulfacetamide 10% Wash can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This Sodium Sulfacetamide 10% Wash should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness in chlidren under the age of 12 years have not ben established.
🆘 Overdosage ▾
OVERDOSAGE : The oral LD 50 of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately. Manifestations : Overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. For treatment, contact your local Poison Control Center or your doctor.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY : Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There is no clinical data available on the degree and rate of systemic absorption of Sodium Sulfacetamide 10% Wash when applied to the skin or scalp.
However, significant absorption of sodium sulfacetamide through the skin has been reported. The following in vitro data is available but the clinical significance is unknown. Organisms that show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae,Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Sodium Sulfacetamide 10% Wash is supplied in the following size(s): 6 fl. oz. (177 mL) bottle, NDC 16477-410-06, and 12 fl. oz (354.8mL) bottle, NDC 16477-410-12
📦 Storage and Handling ▾
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). See USP Controlled Room Temperature. Protect from freezing.
NOTICE : Store upright. Protect from freezing and excessive heat. The wash may tend to darken slightly on storage.
Slight discoloration does not impair the efficacy or safety of the product. 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.
📋 Description ▾
Description: Each mL contains 100 mg of sodium sulfacetamide in a vehicle consisting of: citric acid, cocamidopropyl betaine, edetate disodium, glycerin, glyceryl stearate, methylparaben, PEG-6 caprylic/capric glycerides, PEG-60 almond glycerides, PEG-150 pentaerythrityl tetrastearate, polysorbate 60, purified water, sodium lauryl sulfate, sodium thiosulfate, xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8H 9N 2NaO 3S•H2O with molecular weight of 254.24.
Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether. image
💬 Information for Patients ▾
Information For Patients : Patients should discontinue the use of Sodium Sulfacetamide 10% Wash if the condition becomes worse or if a rash develops in the area being treated or elsewhere. The use of Sodium Sulfacetamide 10% Wash also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop.