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Sodium Sulfacetamide 10 Sulfur 5 Cleanser 10 mg/g; 5 mg/g Rinse, 227 g — NDC 42192-0136-08 package photo

Sodium Sulfacetamide 10 Sulfur 5 Cleanser 10 mg/g; 5 mg/g Rinse, 227 g

by Acella Pharmaceuticals, LLC · 227 g in 1 BOTTLE (42192-136-08)
NDC 42192-0136-08
🏷️ FDA NDC (as labeled) 42192-136-08 billing pads the product segment with a zero
This package
Contains227 g Cost per g$0.3767 NADAC Per package$85.51 / 227 g Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.3090/unit — full pricing hub ↓
Also comes in: 170.3 g 42192-0136-06 340.2 g 42192-0136-12
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Past resolved recalls for this product (1)
Class III · Apr 24, 2024 · Terminated — Subpotent drug (Acella Pharmaceuticals, LLC) · FDA recall D-0490-2024

🆔 Identity & classification

FDA NDC (as labeled) 42192-136-08
Product NDC 42192-136
11-digit billing NDC 42192013608
NCPDP billing unit GM — per gram (weight)
UNII 4NRT660KJQ, 70FD1KFU70
SPL Set ID 1926eadd-d11f-44fa-971f-0041060f7589
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 2012-04-20
Route TOPICAL
Dosage form RINSE
Substance SULFACETAMIDE SODIUM; SULFUR
GPI-14 90059903200927
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 42192-136-08 — 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 → 42192-0136-08. 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.

🏭 Manufacturer & labeler

LabelerAcella Pharmaceuticals, LLC
Labeler code42192
First marketedApr 2012
Product typeHuman Prescription Drug
Portfolio36 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 topical rinse containing sodium sulfacetamide and sulfur. Sodium sulfacetamide is an antimicrobial sulfonamide typically used in skincare products to help reduce bacteria on the skin surface. Sulfur is commonly used in dermatological products for its keratolytic and antimicrobial properties, often included in formulations for acne-prone or seborrheic skin. This product is marketed without an approved FDA application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

💊 What it looks like

Color yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 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 0MBZ20845F
    A synthetic cleanser and emulsifier derived from oleic acid. It helps mix oil and water-based ingredients together and reduces surface tension, improving how the medicine spreads or dissolves in the formulation.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • 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.
  • 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 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 518XTE8493
    A gentle cleanser derived from coconut oil, sodium cocoyl isethionate serves as a surfactant and foaming agent in topical products. It helps the medicine spread evenly on skin and creates lather.
  • UNII JVL98CG53G
    Sodium methyl cocoyl taurate is a mild, plant-derived cleaning agent made from coconut oil and an amino acid. It's used in liquid formulations as a surfactant to help mix oil and water-based ingredients together and improve how the medicine spreads or is absorbed.
  • 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 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.

17 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 systemPer gPer package
Retail pharmacies payNADAC · weekly $0.377 $85.51 / 227 g
Medicaid paysCMS SDUD · 12 mo $0.3090 $70.14 / 227 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
Oct 2021 Sep 2022 Feb 2026 Aug 2026 $1.163 $0.303
▼ Down 68% over the last 18 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 58657-0472-06 Method 170 g $0.089 — Availability likely save 76%
Sodium Sulfacetamide, Sulfur 100 mg/g; 50 mg/g 69367-0247-06 Westminster 170.3 g $0.175 — Availability likely save 54%
Sodium Sulfacetamide 10 Sulfur 5 Cleanser 10 mg/g; 5 mg/gthis 42192-0136-08 Acella 227 g $0.377 — 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

🏛️
2012
On the market since
Apr 2012
📍
2026
Currently FDA-listed
14 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 42192-0136-08, 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 – Q4 2025 · 4 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
1.4K
Units reimbursed last 4 qtrs
324K
Gross reimbursed last 4 qtrs
$100.1K
Avg / prescription
$70.55
Avg / unit
$0.3090
Latest quarter Q4 2025
204Rx
Medicaid pays / g
$0.3090
gross reimbursed
vs
NADAC / g
$0.3767
acquisition cost
=
Spread
−$0.0677
-18% 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 ⓘ
89% MCO
Fee-for-service · 156 Rx Managed care · 1,263 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 11,804 units · 151 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 14,074 units · 245 per 100k residents MN Wisconsin: 35,639 units · 603 per 100k residents WI Michigan: 42,208 units · 421 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 31,553 units · 268 per 100k residents OH Pennsylvania: 153,169 units · 1,182 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 6,810 units · 78.1 per 100k residents VA Maryland: 18,330 units · 297 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 3,178 units · 69.5 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 7,264 units · 32.1 per 100k residents FL
Units reimbursed · per 100k residents
32.11,182
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
🏆 Top states by units · per 100k residents
1 Pennsylvania 1,182 /100k
2 Wisconsin 603 /100k
3 Michigan 421 /100k
4 Maryland 297 /100k
5 Ohio 268 /100k
6 Minnesota 245 /100k
7 Washington 151 /100k
8 Virginia 78.1 /100k
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.
170 gs42192-0136-06 9,258 Rx · $288,972
340 gs42192-0136-12 3,145 Rx · $164,813
227 gs this page42192-0136-08 1,419 Rx · $100,114
Drug total (last 4 qtrs): 13,822 Rx · 3,019,363 units · $553,899 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
42192-0136-06 170.3 g in 1 BOTTLE (42192-136-06) $0.1750 / g $29.80 2012-04-20 Active
42192-0136-08 You're viewing this 227 g in 1 BOTTLE (42192-136-08) $0.3767 / g $85.51 2016-09-19 Active
42192-0136-12 340.2 g in 1 BOTTLE (42192-136-12) $0.1539 / g $52.35 2012-04-20 Active

Per g, this pack runs about 145% above the cheapest pack (340.2 g in 1 BOTTLE (421, $0.1539 vs $0.3767 NADAC).

This pack accounts for about 10% of this product's recent Medicaid fills; most go to the 170 gs pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 42192-0136-08?
NDC 42192-0136-08 contains 227 g — 227 g in 1 bottle.
What is the difference between NDC 42192-0136-08 and NDC 42192-0136-06?
Both are Sodium Sulfacetamide 10 Sulfur 5 Cleanser 10 mg/g; 5 mg/g Rinse — the drug itself is identical. NDC 42192-0136-08 is the 227 g package, while NDC 42192-0136-06 is the 170.3 g package. Per-g NADAC also differs: $0.3767 here vs $0.1750 for the 170.3 g pack.
What NDC number is used to bill for this package of Sodium Sulfacetamide 10 Sulfur 5 Cleanser 10 mg/g; 5 mg/g Rinse?
Bill NDC 42192-0136-08 — the 11-digit billing format is 42192013608. 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 42192-136-08, 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: 42192-0136-08, written without dashes as 42192013608. 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 42192-0136-08, the first segment (42192) is the labeler code FDA assigned to Acella Pharmaceuticals, LLC; the middle segment (0136) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 Acella 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 2 other package presentations of this same product, including 170.3 g (42192-0136-06), 340.2 g (42192-0136-12). 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?
Acella 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 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 22 words ▾

INDICATIONS: Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

⏱️ Dosage and Administration 73 words ▾

DOSAGE AND ADMINISTRATION: Apply Sodium Sulfacetamide 10% - Sulfur 5% Cleanser 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 10% - Sulfur 5% Cleanser sooner or using less often.

⛔ Contraindications 44 words ▾

CONTRAINDICATIONS: Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is contraindicated for use by patients having known 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 67 words ▾

WARNINGS: Although rare, sensitivity to sodium sulfacetaminde 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.

🤒 Adverse Reactions 10 words ▾

ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.

🤰 Pregnancy 63 words ▾

PREGNANCY: Category C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% - Sulfur 5% Cleanser. It is not known whether Sodium Sulfacetamide 10% - Sulfur 5% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% - Sulfur 5% Cleanser should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 16 words ▾

PEDIATRIC USE: Safety and effectiveness in children under the age of 12 have not been established.

🧬 Clinical Pharmacology 112 words ▾

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 not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

📦 How Supplied / Storage and Handling 150 words ▾

HOW SUPPLIED: Sodium Sulfacetamide 10% - Sulfur 5% Topical Suspension is available in 6 oz (170.3 g) bottles, NDC 42192-136-06, 8 oz (227 g) bottles, 42192-136-08 and 12 oz (340.2 g) bottles, NDC 42192-136-12. Store at 20° -25°C (68°-77°F); excursions permitted to 15° - 30°C (59° -86°F). [See USP Controlled Room Temperature). Protect from freezing.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing.

No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.

📦 Storage and Handling 21 words ▾

Store at 20° -25°C (68°-77°F); excursions permitted to 15° - 30°C (59° -86°F). [See USP Controlled Room Temperature). Protect from freezing.

📋 Description 93 words ▾

DESCRIPTION: Each ml of Sodium Sulfacetamide 10% - Sulfur 5% Cleanser contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur in a formulation containing Butylated Hydroxytoluene, Cetyl Alcohol, Disodium EDTA, Disodium Oleamido MIPA Sulfosuccinate, Glyceryl Slearate, Magnesium Aluminum Silicate, Methylparaben, PEG-100 Stearate, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Cocoyl lsethionate, Sodium Melhyl Cocoyl Taurale, Sodium Thiosulfate, Stearyl Alcohol, Xanthan Gum. 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: Chemical Structure

💬 Information for Patients 30 words ▾

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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 42192-0135-10 · Acella 42192-0139-01 · Acella →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.