Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g Liquid, 170.3 g
by Method Pharmaceuticals, LLC · 170.3 g in 1 BOTTLE, PLASTIC (58657-472-07)
NDC 58657-0472-07
🏷️ FDA NDC (as labeled)
58657-472-07
billing pads the product segment with a zero
This package
Also priced by: Medicaid pays $0.1173/unit — full pricing hub ↓
Rx only
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
58657-472-07
Product NDC
58657-472
11-digit billing NDC
58657047207
NCPDP billing unit
GM — per gram (weight)
RxCUI
999613
UNII
4NRT660KJQ, 70FD1KFU70
SPL Set ID
d35a7764-f3c6-fd1b-e053-2a95a90a8036
Established class (EPC)
Sulfonamide Antibacterial
Chemical class
Sulfonamides
DEA schedule
Non-controlled
Marketing category
UNAPPROVED DRUG OTHER
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2021-11-15
Route
TOPICAL
Dosage form
LIQUID
Substance
SULFACETAMIDE SODIUM; SULFUR
GPI-14
90059903200927
GPI class
Sulfacetamide Sodium-Sulfur
GCN Seq No
045670
GCN
48810
HICL code
003344
Ingredient (HICL)
Sulfacetamide Sodium/Sulfur
HIC1 code
Q
Therapeutic class — broad (HIC1)
Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code
Q5
Therapeutic class — intermediate (HIC2)
Agents Acting Principally On The Skin
HIC3 code
Q5S
Therapeutic class — specific (HIC3)
Topical Sulfonamides
AHFS code
84:04.92.00
AHFS class
Local Anti-Infectives, Miscellaneous
FDB label name
SOD SULFACET-SULFUR 10-5% CLSR
FDB brand name
Sodium Sulfacetamide-Sulfur
Legend status
F — Federal legend — prescription drug or device
Why two NDCs?
The FDA registers this code as 58657-472-07 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 58657-0472-07. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏷️ RxNorm drug class
This medicine belongs to the Sulfonamide Antibacterial class.
Pharmacologic class
Sulfonamide Antibacterial
Drug family (ATC)
Antiinfectives for treatment of acne, Sulfonamides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerMethod Pharmaceuticals, LLC
Labeler code58657
First marketedNov 2021
Product typeHuman Prescription Drug
Portfolio78 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
Label name SOD SULFACET-SULFUR 10-5% CLSR Ingredient Sulfacetamide Sodium/Sulfur
🧪 What is this product?
This is a liquid topical preparation containing sulfacetamide sodium and sulfur. Sulfacetamide sodium is an antimicrobial sulfonamide typically used on skin to help reduce bacteria, while sulfur is commonly used in dermatology products for its antimicrobial and keratolytic (skin-softening) properties. Together, these ingredients are often combined in formulations applied to the skin for conditions involving bacterial overgrowth or excess oil. This product is marketed without an approved FDA application.
Patient education
Supplement & herbal interactions
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about SULFACETAMIDE SODIUM, SULFUR?
Ask a pharmacist →
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.
-
UNII Y7R23627P5
A salt form of citric acid used as a plasticizer and solvent in medicines. It softens tablet coatings and film layers to improve flexibility and helps dissolve or suspend active ingredients in liquid formulations.
-
UNII ZY81Z83H0X
Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
-
UNII 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
-
UNII 936JST6JCN
Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
-
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.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
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.
-
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.
-
UNII YD01N1999R
A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
-
UNII HIE492ZZ3T
Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
-
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.
-
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.
-
UNII 2KR89I4H1Y
Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
-
UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
-
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.
-
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.
16 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 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 g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.153 | $26.12 / 170.3 g |
| Medicaid paysCMS SDUD · 12 mo | $0.1173 | $19.98 / 170.3 g |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per g) — tap or hover for the price & month
▼ Down 17% over the last 16 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sodium Sulfacetamide 10 Sulfur 5 Cleanser 10 mg/g; 5 mg/g 42192-0136-06 | Acella | 170.3 g | $0.153 | — | Availability likely | — |
| Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/gthis 58657-0472-07 | Method | 170.3 g | $0.153 | — | Availability likely | — |
| Sodium Sulfacetamide, Sulfur 100 mg/g; 50 mg/g 69367-0247-06 | Westminster | 170.3 g | $0.153 | — | Availability likely | — |
| Avar 100 mg/g; 50 mg/g 00178-0480-08 | Mission | 227 g | — | — | FDA listed | — |
| Sulfacetamide Sodium, Sulfur 50 mg/g; 100 mg/g 24470-0925-08 | Cintex | 227 g | — | — | FDA listed | — |
| Sodium Sulfacetamide, Sulfur 100 mg/g; 50 mg/g 24470-0953-06 | Cintex | 170.3 g | — | — | FDA listed | — |
| Sulfacetamide Sodium, Sulfur 100 mg/g; 50 mg/g 44523-0560-08 | BioComp | 227 g | — | — | FDA listed | — |
| Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser 100 mg/g; 50 mg/g 50405-0850-01 | SOHM, | 170 g | — | — | FDA listed | — |
| Sodium Sulfacetamide, Sulfur 100 mg/g; 50 mg/g 52187-0536-06 | KMM | 170.3 g | — | — | FDA listed | — |
| Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 63629-9259-01 | Bryant | 170 g | — | — | FDA listed | — |
| Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 63629-9260-01 | Bryant | 170.3 g | — | — | FDA listed | — |
| Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 63629-9261-01 | Bryant | 227 g | — | — | FDA listed | — |
| Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 71335-2940-01 | Bryant | 227 g | — | — | FDA listed | — |
| Sodium Sulfacetamide 10% and Sulfur 5% Cleanser 100 mg/g; 50 mg/g 71399-0488-06 | Akron | 170.3 g | — | — | FDA listed | — |
| Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 72162-1664-02 | Bryant | 277 g | — | — | FDA listed | — |
| Sulfacetamide Sodium, Sulfur 50 mg/mL; 100 mg/mL 81542-0202-12 | Bantry | 355 ml | — | — | FDA listed | — |
| Sodium Sulfacetamide 10% and Sulfur 5% Cleanser 100 mg/g; 50 mg/g 83720-0547-06 | Oncor | 170 g | — | — | FDA listed | — |
| Sodium Sulfacetamide, Sulfur 100 mg/g; 50 mg/g 87026-0202-06 | Aspen | 170 g | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2021
On the market since
Nov 2021
📍
2026
Currently FDA-listed
5 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 58657-0472-07, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
24
Units reimbursed last 4 qtrs
4.1K
Gross reimbursed last 4 qtrs
$479.52
Avg / prescription
$19.98
Avg / unit
$0.1173
Latest quarter Q1 2026
0Rx
Medicaid pays / g
$0.1173
gross reimbursed
vs
NADAC / g
$0.1534
acquisition cost
=
Spread
−$0.0361
-24% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 0 Rx Managed care · 24 Rx
State Medicaid map
Units reimbursed · per 100k residents
44.044.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
💊 Medicaid utilization by pack size
Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 216 Rx · 54,945 units · $8,944 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Sodium Sulfacetamide-Sulfur (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sodium Sulfacetamide-Sulfur. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$21.7K
Claims incl. refills
79
Beneficiaries
63
Spend / beneficiary
$344.29
Spend / claim
$274.56
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for SULFACETAMIDE SODIUM, SULFUR — the ingredient across all brands.
Top reported reactions
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 58657-0472-06 | 170 g in 1 BOTTLE, PLASTIC (58657-472-06) | $0.0891 / g | $15.15 | 2021-11-15 | Active |
| 58657-0472-07 You're viewing this | 170.3 g in 1 BOTTLE, PLASTIC (58657-472-07) | $0.1534 / g | $26.13 | 2021-11-15 | Active |
| 58657-0472-08 | 227 g in 1 BOTTLE, PLASTIC (58657-472-08) | $0.3906 / g | $88.66 | 2021-11-15 | Active |
| 58657-0472-12 | 340 g in 1 BOTTLE, PLASTIC (58657-472-12) | $0.1011 / g | $34.38 | 2021-11-15 | Active |
| 58657-0472-13 | 340.2 g in 1 BOTTLE, PLASTIC (58657-472-13) | $0.1464 / g | $49.82 | 2021-11-15 | Active |
Per g, this pack runs about 72% above the cheapest pack (170 g, $0.0891 vs $0.1534 NADAC).
This pack accounts for about 11% of this product's recent Medicaid fills; the largest share goes to the 227 g pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 58657-0472-07?
NDC 58657-0472-07 contains 170.3 g — 170.3 g in 1 bottle, plastic.
What is the difference between NDC 58657-0472-07 and NDC 58657-0472-06?
Both are Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g Liquid — the drug itself is identical. NDC 58657-0472-07 is the 170.3 g package, while NDC 58657-0472-06 is the 170 g package. Per-g NADAC also differs: $0.1534 here vs $0.0891 for the 170 g pack.
What NDC number is used to bill for this package of Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g Liquid?
Bill NDC 58657-0472-07 — the 11-digit billing format is 58657047207. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
Finished prescription product
Marketed without an FDA application
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) | ✓ Available |
| 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) | ✓ Available |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 58657-472-07, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 58657-0472-07, written without dashes as 58657047207. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 58657-0472-07, the first segment (58657) is the labeler code FDA assigned to Method Pharmaceuticals, LLC; the middle segment (0472) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Method Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 170 g (58657-0472-06), 227 g (58657-0472-08), 340 g (58657-0472-12). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Method Pharmaceuticals, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 Full prescribing information FDA SPL
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⛔ Contraindications
⚠️ Warnings
🧬 Clinical Pharmacology
📋 Description
🎯 Indications and Usage ▾
INDICATIONS SODIUM SULFACETAMIDE 10% - SULFUR 5% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION USE: 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. FOR EXTERNAL USE ONLY.
NOT FOR INTRAVAGINAL OR OPHTHALMIC USE. (KEEP AWAY FROM EYES). KEEP OUT OF REACH OF CHILDREN.
⛔ Contraindications ▾
CONTRAINDICATIONS: Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is contraindicated in persons with know or suspected hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is not to be used by patients with kidney disease.
⚠️ Warnings ▾
WARNINGS Although 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. 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 OUT OF REACH OF CHILDREN.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 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 unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.
📋 Description ▾
DESCRIPTION Each gram of sodium sulfacetamide 10% and sulfur 5% cleanser contains 100 mg of sodium sulfacetamide and 50 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: desc
No label section mentions that — try another word, or open the full label on DailyMed below.
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