FDA-filed SPL labeling · retrieved through openFDA

Silver Sulfadiazine

Silver sulfadiazine is a topical antimicrobial cream used to help prevent and treat wound infections in patients with second- and third-degree burns.

Brand names SilvadeneSSD CreamThermazeneSsdRayaSore Kit +1 more
Drug class Sulfonamide Antibacterial
Rx Form 1 Route Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 31 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJan 26, 2026
Clinical labels in scope 31
AvailabilityRx
Earliest approval/marketing year 1973
FDA-listed product records 78
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Silver Sulfadiazine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Silver sulfadiazine cream is a well-established topical antibiotic used in burn care to prevent and treat serious wound infections. It is applied directly to second- and third-degree burns once or twice daily as part of a full burn treatment plan. Because it belongs to the sulfa drug family, your care team will watch for rare but serious blood, skin, or kidney reactions — especially if the burn covers a large area of the body.

📖 Silver Sulfadiazine: Patient Information Guide

A plain-language walkthrough of Silver Sulfadiazine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Silver sulfadiazine cream is a topical (applied to the skin) antimicrobial drug used in burn care. All supported products are indicated for:

  • Prevention and treatment of wound sepsis (serious wound infection) in patients with second- and third-degree burns — indicated for Silvadene Cream 1%, Silver Sulfadiazine cream, SSD Cream, Ssd, and Thermazene cream

It is used as part of — not as a replacement for — a full burn treatment program.

⚙️How it works

Silver sulfadiazine kills bacteria by directly attacking the bacterial cell wall — a different mechanism from other silver-based or sulfa-based agents. It has broad antimicrobial activity against a wide range of gram-positive bacteria (like Staphylococcus aureus), gram-negative bacteria (like Pseudomonas aeruginosa and E. coli), and even certain yeasts like Candida albicans.

Importantly, it can eliminate bacteria that have become resistant to other antimicrobials, making it especially valuable in complex burn wounds. It is not a carbonic anhydrase inhibitor, so it can be used in patients for whom that class of agent is not suitable.

💊How it's taken

Silver sulfadiazine cream is for topical use only — it is applied directly to the wound, not taken by mouth or used near the eyes. After the burn is cleaned and debrided, the cream is applied in a layer of about 1/16 inch once or twice daily under sterile conditions.

  • The wound area should be kept covered with cream at all times — reapply whenever it has been wiped or rubbed off
  • Reapply immediately after hydrotherapy (water-based wound cleaning)
  • Bandage dressings are optional but can be used if needed
  • Continue treatment until the wound heals or is ready for a skin graft; do not stop while infection is still possible unless a serious reaction occurs
🤒Side effects — in detail

The most commonly reported side effect is a temporary drop in white blood cell count. Other reported effects include:

  • Leukopenia — low white blood cell count, especially neutrophils; usually appears within 2–4 days and resolves on its own within 2–3 days
  • Burning sensation at the application site
  • Skin rash
  • Skin discoloration
  • Skin necrosis (localized tissue damage)
  • Erythema multiforme (a skin reaction with target-shaped spots)
  • Interstitial nephritis (inflammation of the kidney's filtering tissue)

More serious reactions — including dangerous blood disorders, severe skin reactions like Stevens-Johnson syndrome, and liver or kidney damage — are rare but require immediate medical attention if they appear.

⚠️Warnings & precautions
  • Serious blood disorders: Because silver sulfadiazine is a sulfonamide, it can rarely cause life-threatening blood problems including agranulocytosis (dangerously low white blood cells), aplastic anemia, and hemolytic anemia (destruction of red blood cells)
  • Life-threatening skin reactions: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) — blistering and widespread skin loss — have been associated with sulfonamide drugs; seek emergency care immediately if these appear
  • G6PD deficiency: People with this inherited enzyme deficiency may experience hemolysis (red blood cell breakdown) when using this cream
  • Liver and kidney effects: If liver or kidney function is impaired, the drug may accumulate; function should be monitored in at-risk patients
  • Large burn areas: When used over a large percentage of the body, enough drug may be absorbed through the skin to reach levels similar to oral sulfa therapy — sulfa blood levels and kidney function (including checking urine for sulfa crystals) should be monitored
  • Fungal overgrowth: Overgrowth of fungi in and below the wound eschar (scab) can occur, though clinically significant cases are uncommon
  • Lab test interference: The propylene glycol vehicle in the cream may affect serum osmolality readings, which could alter how some lab results are interpreted
🔀What it interacts with

Silver sulfadiazine has a few notable interactions to be aware of:

  • Cimetidine — using this acid-reducing drug at the same time has been linked to a higher rate of leukopenia (low white blood cell count)
  • Topical proteolytic enzymes (wound-debridement enzymes applied to the skin) — the silver in the cream may inactivate these enzymes, reducing their effectiveness if used together

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not use if you have a known allergy to silver sulfadiazine or any sulfonamide (sulfa) medication — there is potential cross-sensitivity among sulfa drugs
  • Do not use on pregnant women approaching or at term — sulfonamides can increase the risk of kernicterus (a serious form of brain damage) in newborns
  • Do not use on premature infants or newborns under 2 months of age for the same reason
  • Tell your doctor if you have G6PD deficiency — hemolysis may occur
  • Tell your doctor if you have liver disease — reduced drug elimination can lead to buildup
  • Tell your doctor if you have kidney disease — renal function should be monitored during treatment
  • If treating large burn areas, blood sulfa levels and kidney function (including urine checks for sulfa crystals) should be monitored
📡Pharmacodynamics — effects in the body

Silver sulfadiazine acts directly on the bacterial cell wall to produce its killing (bactericidal) effect. It is effective against a broad spectrum of gram-positive and gram-negative bacteria as well as yeast, and laboratory testing shows it can inhibit bacteria that are resistant to other antimicrobial agents. A transient drop in white blood cell count (leukopenia) — primarily neutrophils — occurs in roughly 20% of patients, typically peaking within 2–4 days and resolving within 2–3 days without stopping therapy.

🔬Pharmacokinetics — how your body processes it

The amount of silver sulfadiazine absorbed through the skin depends on the size of the burn and the degree of tissue damage. When used over large areas of the body, absorption can be significant enough that blood sulfa concentrations may approach the therapeutic levels seen with oral sulfa drugs (8–12 mg%). The propylene glycol in the cream formulation can also be absorbed and may affect serum osmolality, which could influence how certain lab values are interpreted.

📦How to store it

Store at Controlled Room Temperature 20° to 25°C (68° to 77°F).

📄 Written from Silver Sulfadiazine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

3

Supplements & herbs that interact with Silver Sulfadiazine

3 supplements and herbal products have documented interactions with Silver Sulfadiazine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Moderate · 2
  • Minor · 1
Every supplement checked against Silver Sulfadiazine — ranked by severity The full interaction hub: 2 moderate · 1 minor · every one linked to its full report. Check Silver Sulfadiazine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Silver Sulfadiazine — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is this cream used for?
Silver sulfadiazine cream is applied to second- and third-degree burn wounds to help prevent and treat serious infection. It's not a standalone treatment — your care team uses it as part of a broader burn care plan that also manages pain and other complications. All the branded versions (Silvadene, SSD Cream, Thermazene, and others) are used for this same purpose.
How do I apply it, and how often?
After the wound is cleaned and any dead tissue is removed, the cream is spread in a thin layer — about 1/16 of an inch — directly over the burn area. It's applied once or twice a day. You don't always need a bandage over it, but one can be used if your care team recommends it. If you have water therapy (hydrotherapy), reapply the cream right after. Keep the burn covered with cream at all times — reapply whenever it gets rubbed off.
My white blood cell count went down — should I be worried?
A temporary dip in white blood cells, especially a type called neutrophils, is actually one of the more commonly reported effects — it happens in roughly 1 in 5 patients. The good news is that it usually shows up within the first 2–4 days and bounces back on its own within 2–3 days, even if you keep using the cream. That said, your care team will keep an eye on your blood counts, so make sure you attend any scheduled lab checks.
Are there any serious reactions I should watch for and call the doctor about?
Yes — because silver sulfadiazine is related to sulfa drugs, rare but serious reactions are possible. Call your care team right away if you notice widespread skin blistering or peeling, which could be a severe reaction called Stevens-Johnson syndrome. Also report signs of liver problems (yellowing of skin or eyes), kidney problems (changes in how much you urinate), or severe fatigue and paleness, which could signal a blood disorder. These are uncommon, but they're important to catch early.
Can this be used during pregnancy or on a baby?
No — this cream should not be used if you are close to your due date or in labor, because sulfa drugs can increase the risk of a serious type of brain damage (kernicterus) in newborns. It also should not be used on premature infants or any baby under 2 months old. If you're pregnant and have a burn wound, talk to your doctor about alternative options for your stage of pregnancy.
I take cimetidine for acid reflux — is that a problem?
It's worth mentioning to your care team. There's evidence that using cimetidine at the same time as silver sulfadiazine cream is linked to a higher rate of low white blood cell counts compared to using the cream alone. Your doctor can decide whether to adjust your medications or monitor your blood counts more closely during treatment.
Is Silver Sulfadiazine available over the counter?
Silver Sulfadiazine is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Silver Sulfadiazine first available?
Silver Sulfadiazine has been available in the United States since at least 1973, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Silver Sulfadiazine?
Silver Sulfadiazine is supplied by 25 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, NuCare Pharmaceuticals,Inc..

💬 Answers drafted from Silver Sulfadiazine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Silver Sulfadiazine comes

Silver Sulfadiazine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Topical cream, ointment or gel

On the skin
Brands Silvadene Ssd SSD Cream Thermazene
How this form is used
What it may be used for
  • Silvadene Cream 1% is indicated to help prevent and treat wound sepsis (infection) in patients with second- and third-degree burns
  • Silver Sulfadiazine cream and Thermazene cream are indicated to help prevent and treat wound sepsis in patients with second- and third-degree burns
  • SSD Cream and Ssd cream are indicated to help prevent and treat wound sepsis in patients with second- and third-degree burns
Important instructions
  • Silvadene Cream 1% should be applied once to twice daily in a layer of approximately 1/16 inch after the wound is cleaned and debrided, under sterile conditions; reapply after hydrotherapy
  • Silver Sulfadiazine Cream, SSD Cream, and Ssd cream should be applied once to twice daily to a thickness of approximately one sixteenth of an inch; reapply whenever the cream has been removed by patient activity
  • Thermazene cream should be applied once to twice daily under sterile conditions; dressings are not required but may be used if needed
  • Treatment with any of these products should continue until the wound heals satisfactorily or is ready for grafting; do not stop while infection risk remains unless a serious reaction occurs
Available strengths 2 strengths
73 FDA-listed product records

📊 Silver Sulfadiazine across the U.S. market

How Silver Sulfadiazine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
25
Manufacturers
7
Brand names
78
FDA-listed product records
1973
First marketed

Also listed with the FDA, not a patient dose form: Powder (4) · Kit (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack23%
A-S Medication Solutions18%
NuCare Pharmaceuticals,Inc.8%
Preferred Pharmaceuticals Inc.5%
Preferred Pharmaceuticals, Inc.4%
Ascend Laboratories, LLC4%
Other makers38%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Silver Sulfadiazine is used

A general measure of how commonly Silver Sulfadiazine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Silver Sulfadiazine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

202,248
Medicaid prescriptions filled (Q1–Q4 2025)
$3.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Silver Sulfadiazine prescribed? Of the 1,596 medications we measure, Silver Sulfadiazine ranks #392 by Medicaid prescriptions — more than 75% of them.

Where Silver Sulfadiazine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Silver Sulfadiazine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

silver sulfadiazine 10 MG/ML Topical Cream

202,248 Medicaid prescriptions (Q1–Q4 2025) 100% of Silver Sulfadiazine prescriptions shown $3.6M gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 23 of 86 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 106351

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Silver Sulfadiazine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 23 of 86 listed Silver Sulfadiazine NDCs with Medicaid activity.

🔍 Compare Silver Sulfadiazine products

A representative set of FDA-listed product records for Silver Sulfadiazine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 78 of 78 products — FDA National Drug Code Directory. See every product, package size and price: browse all 78 Silver Sulfadiazine NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Silver Sulfadiazine RxCUI 9793 1 dose form · 1 strength
  1. Dose form (SCDF) Topical Cream RxCUI 377813 In current FDA listings
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 106351

Look up RxCUI 9793 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Silvadene SSD Cream Thermazene Ssd RayaSore Kit Thermazene Silver Sulfadiazine

🏭 Manufacturers & labelers

Bryant Ranch Prepack 18 A-S Medication Solutions 14 NuCare Pharmaceuticals,Inc. 6 Preferred Pharmaceuticals Inc. 4 Preferred Pharmaceuticals, Inc. 3 Ascend Laboratories, LLC 3 Direct Rx 3 RPK Pharmaceuticals, Inc. 3 Remedyrepack Inc. 3 Advanced Rx Pharmacy of Tennessee, LLC 2 Pfizer Laboratories Div Pfizer Inc 2 Proficient Rx LP 2 Dr Reddys Laboratories Inc 2 Asclemed USA, Inc. 2 Raya Pharmaceuticals LLC 1 Spectrum Laboratory Products, Inc. 1 St. Mary's Medical Park Pharmacy 1 TAPI Croatia Industries Ltd. 1 NuCare Pharmaceuticals, Inc. 1 Mylan Pharmaceuticals Inc. 1 Medsource Pharmaceuticals 1 Macsen Drugs 1 Lusochimica SPA 1 Lake Erie Medical DBA Quality Care Products LLC 1

…and 1 more on the FDA NDC directory.

RxNorm drug class

Silver Sulfadiazine belongs to the Sulfonamide Antibacterial class.

Pharmacologic class Sulfonamide Antibacterial
Drug family (ATC) Sulfonamides

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 26, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Silver Sulfadiazine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Silver Sulfadiazine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
31
NDC products indexed
78
Distinct labelers/manufacturers represented
25
Linked representative label
Pfizer Laboratories Div Pfizer Inc
Linked label effective
Jan 26, 2026
Composite sections available
15
Linked SPL Set ID
c437213a-1cd4-445e-a39f-bbcacb9f746f
Linked SPL Document ID
2d9a5dc8-0dfd-42b8-a641-b4b82a113fab
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 31 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Pfizer Laboratories Div Pfizer Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.