HomeNDC LookupIngredientsSilver Sulfadiazine › 43598-0210-50
SSD Cream Silver Sulfadiazine 10 g/1000g Cream, 50 g — NDC 43598-0210-50 package photo

SSD Cream Silver Sulfadiazine 10 g/1000g Cream, 50 g

by Dr Reddys Laboratories Inc · 50 g in 1 TUBE (43598-210-50)
NDC 43598-0210-50
🏷️ FDA NDC (as labeled) 43598-210-50 billing pads the product segment with a zero
This package
Contains50 g Cost per g$0.2551 NADAC Per package$12.76 / 50 g Pack sizes5 compare ↓
Also priced by: Medicaid pays $0.3164/unit · Part D plans $0.2130/unit — full pricing hub ↓
Rx only Brand 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) 43598-210-50
Product NDC 43598-210
11-digit billing NDC 43598021050
NCPDP billing unit GM — per gram (weight)
RxCUI 106351, 208185
UNII W46JY43EJR
UPC 0343598210551, 0343598210858, 0343598210254
Application # NDA018578
SPL Set ID 30d6dc33-e457-466b-9159-d8e7cd791820
Established class (EPC) Sulfonamide Antibacterial
Chemical class Sulfonamides
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-05-04
Marketing end 2028-01-31
Route TOPICAL
Dosage form CREAM
Substance SILVER SULFADIAZINE
GPI-14 90450030003710
GPI class SSD
GCN Seq No 007669
GCN 31630
HICL code 003347
Ingredient (HICL) Silver Sulfadiazine
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 84:04.16.00
AHFS class Astringents, Anti-Infective
FDB label name SSD 1% CREAM
FDB brand name Ssd
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 43598-210-50 — 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 → 43598-0210-50. 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) 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

LabelerDr Reddys Laboratories Inc
Application holderDR REDDYS LABORATORIES INC
FDA applicationNDA018578 (NDA)
Labeler code43598
First marketedMay 2011
Product typeHuman Prescription Drug
Portfolio5 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 SSD 1% CREAM Ingredient Silver Sulfadiazine
📖 What it is MedlinePlus · NLM

Silver sulfadiazine, a sulfa drug, is used to prevent and treat infections of second- and third-degree burns. It kills a wide variety of bacteria. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • 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 a...
  • 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 d...
  • 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...
  • My white blood cell count went down — should I be worried?
📖 Read our full Silver Sulfadiazine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Silver Sulfadiazine — tap one for details:

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.

🧪 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 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 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • 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 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 13A4J4NH9I
    A synthetic emulsifier derived from stearic acid and polyethylene glycol. It helps mix oil and water-based ingredients together in liquid medicines and creams to create a smooth, uniform product.
  • 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 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
  • 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.

9 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 DailyMedingredient 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 $0.255 $12.76 / 50 g
Medicaid paysCMS SDUD · 12 mo $0.3164 $15.82 / 50 g
Medicare drug plans payPart D · Q2 2026 $0.2130 $10.65 / 50 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.255 $0.122
▲ Up 109% over the last 24 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
SSD Cream 10 g/1000gthis 43598-0210-50 Dr 50 g $0.255 AB Availability likely
Silver sulfadiazine 10 mg/g 67877-0124-05 Ascend 50 g $0.255 AB Availability likely
Silver Sulfadiazine 10 mg/g 59762-0131-00 Mylan 1 tube $0.403 AB Availability likely +58%
Silvadene 10 mg/g 61570-0131-20 Pfizer 1 tube $0.433 AB Availability likely +70%
Silvadene 10 mg/g 50090-0230-00 A-S 1 tube AB FDA listed
Silver Sulfadiazine 10 mg/g 50090-0607-00 A-S 50 g AB FDA listed
Silver Sulfadiazine 10 mg/g 50090-0717-00 A-S 50 g AB FDA listed
Silver Sulfadiazine 10 mg/g 50090-0763-00 A-S 25 g AB FDA listed
Silver Sulfadiazine 10 mg/g 50090-2152-00 A-S 400 g AB FDA listed
Ssd 10 g/1000g 50090-7447-00 A-S 50 g AB FDA listed
SSD Cream 10 g/1000g 60760-0962-50 St. 50 g AB FDA listed
Silver Sulfadiazine 10 g/1000g 61919-0237-25 DIRECT 25 g AB FDA listed
Silver Sulfadiazine 10 mg/g 63187-0023-25 Proficient 25 g AB FDA listed
Silver Sulfadiazine 10 mg/g 63629-8768-01 Bryant 20 g AB Discontinued
Silver Sulfadiazine 10 mg/g 63629-8769-01 Bryant 25 g AB Discontinued
Silver Sulfadiazine 10 mg/g 63629-8770-01 Bryant 50 g AB Discontinued
Silver Sulfadiazine 10 mg/g 63629-8771-01 Bryant 50 g AB Discontinued
Silver Sulfadiazine 10 mg/g 63629-8772-01 Bryant 85 g AB Discontinued
Silver Sulfadiazine 10 mg/g 63629-8773-01 Bryant 400 g AB Discontinued
Silver Sulfadiazine 10 g/1000g 68071-2473-05 NuCare 50 g AB FDA listed
SSD Cream 10 g/1000g 68071-3867-05 NuCare 50 g AB FDA listed
Thermazene Silver Sulfadiazine 10 mg/g 68788-0600-02 Preferred 25 g AB FDA listed
SSD Cream 10 g/1000g 68788-8074-02 Preferred 25 g AB FDA listed
Silver Sulfadiazine 10 g/1000g 76420-0208-25 Asclemed 25 g AB FDA listed
Silver Sulfadiazine 10 mg/g 80425-0221-01 Advanced 50 g AB FDA listed
Silver Sulfadiazine 10 mg/g 87063-0078-05 Asclemed 50 g AB FDA listed
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2011
On the market since
May 2011
📍
2026
Currently FDA-listed
15 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 43598-0210-50, 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
8.8K
Units reimbursed last 4 qtrs
470.5K
Gross reimbursed last 4 qtrs
$148.9K
Avg / prescription
$16.99
Avg / unit
$0.3164
Latest quarter Q4 2025
1.1KRx
Medicaid pays / g
$0.3164
gross reimbursed
vs
NADAC / g
$0.2551
acquisition cost
=
Spread
+$0.0613
+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
56% FFS 44% MCO
Fee-for-service · 4,870 Rx Managed care · 3,890 Rx
State Medicaid map
Alaska: 2,750 units · 375 per 100k residents AK Maine: no data reported ME Washington: 1,200 units · 15.4 per 100k residents WA Idaho: no data reported ID Montana: 2,250 units · 199 per 100k residents MT North Dakota: no data reported ND Minnesota: 1,350 units · 23.5 per 100k residents MN Wisconsin: 3,270 units · 55.3 per 100k residents WI Michigan: 36,125 units · 360 per 100k residents MI New York: 103,905 units · 531 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 5,300 units · 125 per 100k residents OR Nevada: 2,600 units · 81.4 per 100k residents NV Wyoming: no data reported WY South Dakota: 1,600 units · 174 per 100k residents SD Iowa: 2,200 units · 68.6 per 100k residents IA Illinois: 8,780 units · 70.0 per 100k residents IL Indiana: 2,350 units · 34.2 per 100k residents IN Ohio: 10,360 units · 87.9 per 100k residents OH Pennsylvania: 16,600 units · 128 per 100k residents PA New Jersey: 24,585 units · 265 per 100k residents NJ Massachusetts: 2,100 units · 30.0 per 100k residents MA California: 124,998 units · 321 per 100k residents CA Utah: no data reported UT Colorado: 2,100 units · 35.7 per 100k residents CO Nebraska: 2,385 units · 121 per 100k residents NE Missouri: 6,755 units · 109 per 100k residents MO Kentucky: 16,985 units · 375 per 100k residents KY West Virginia: 2,350 units · 133 per 100k residents WV Virginia: 5,155 units · 59.1 per 100k residents VA Maryland: 3,160 units · 51.1 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 5,575 units · 75.0 per 100k residents AZ New Mexico: 1,350 units · 63.9 per 100k residents NM Kansas: 500 units · 17.0 per 100k residents KS Arkansas: 600 units · 19.6 per 100k residents AR Tennessee: 2,300 units · 32.3 per 100k residents TN North Carolina: 6,100 units · 56.3 per 100k residents NC South Carolina: 2,100 units · 39.1 per 100k residents SC Delaware: no data reported DE Oklahoma: 5,150 units · 127 per 100k residents OK Louisiana: 20,127 units · 440 per 100k residents LA Mississippi: 3,300 units · 112 per 100k residents MS Alabama: no data reported AL Georgia: 7,200 units · 65.3 per 100k residents GA D.C.: no data reported DC Hawaii: 650 units · 45.3 per 100k residents HI Texas: 22,530 units · 73.9 per 100k residents TX Florida: 650 units · 2.9 per 100k residents FL
Units reimbursed · per 100k residents
2.9531
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 New York 531 /100k
2 Louisiana 440 /100k
3 Kentucky 375 /100k
4 Alaska 375 /100k
5 Michigan 360 /100k
6 California 321 /100k
7 New Jersey 265 /100k
8 Montana 199 /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.
50 gs43598-0210-55 17,019 Rx · $245,470
50 gs this page43598-0210-50 8,760 Rx · $148,870
400 gs43598-0210-40 7,574 Rx · $274,398
25 gs43598-0210-25 5,697 Rx · $54,676
85 gs43598-0210-85 4,829 Rx · $89,745
Drug total (last 4 qtrs): 43,879 Rx · 5,017,001 units · $813,159 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 Silver Sulfadiazine (matched by generic name) — the program that covers self-administered drugs. 2 manufacturers.
⚠️ 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 Silver Sulfadiazine. CMS lists 3 products for this generic; we show the highest-spend one. 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
$2.77M
Claims incl. refills
136.7K
Beneficiaries
106.4K
Spend / beneficiary
$26.00
Spend / claim
$20.23
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 SSD Cream (this brand).

Top reported reactions

Pain97
Chronic Kidney Disease86
Fatigue86
Death72
Diarrhoea67
Acute Kidney Injury66
Nausea66

Age at onset

Neonate4
Child4
Adolescent3
Adult132
Elderly108

Reporter sex

1,391 reports
Male · 45%
Female · 55%
Unknown · 0%

Serious outcomes

Death174
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 174 0
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 NDCDescription Per unit Per pack Marketing startStatus
43598-0210-25 25 g in 1 TUBE (43598-210-25) $0.3159 / g $7.90 2011-05-04 Active
43598-0210-40 400 g in 1 JAR (43598-210-40) $0.1265 / g $50.61 2011-05-04 Active
43598-0210-50 You're viewing this 50 g in 1 TUBE (43598-210-50) $0.2551 / g $12.76 2011-05-04 Active
43598-0210-55 50 g in 1 JAR (43598-210-55) $0.2551 / g $12.76 2011-05-04 Active
43598-0210-85 85 g in 1 TUBE (43598-210-85) $0.2622 / g $22.28 2011-05-04 Active

Per g, this pack runs about 102% above the cheapest pack (400 g, $0.1265 vs $0.2551 NADAC).

This pack accounts for about 20% of this product's recent Medicaid fills; the largest share goes to the 50 gs pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 43598-0210-50?
NDC 43598-0210-50 contains 50 g — 50 g in 1 tube.
What is the difference between NDC 43598-0210-50 and NDC 43598-0210-25?
Both are SSD Cream Silver Sulfadiazine 10 g/1000g Cream — the drug itself is identical. NDC 43598-0210-50 is the 50 g package, while NDC 43598-0210-25 is the 25 g package. Per-g NADAC also differs: $0.2551 here vs $0.3159 for the 25 g pack.
What NDC number is used to bill for this package of SSD Cream Silver Sulfadiazine 10 g/1000g Cream?
Bill NDC 43598-0210-50 — the 11-digit billing format is 43598021050. 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.

📄 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 31 words

INDICATIONS AND USAGE Silver Sulfadiazine Cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.

⏱️ Dosage and Administration 178 words

DOSAGE AND ADMINISTRATION: FOR TOPICAL USE ONLY - NOT FOR OPHTHALMIC USE: Prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain. The burn wounds are then cleansed and debrided; Silver Sulfadiazine Cream is then applied under sterile conditions. The burn areas should be covered with Silver Sulfadiazine Cream at all times.

The cream should be applied once to twice daily to a thickness of approximately one sixteenth of an inch. Whenever necessary, the cream should be reapplied to any areas from which it has been removed due to patient activity. Administration may be accomplished in minimal time because dressings are not required.

However, if individual patient requirements make dressings necessary, they may be used. Reapply immediately after hydrotherapy. Treatment with Silver Sulfadiazine Cream should be continued until satisfactory healing has occurred or until the burn site is ready for grafting.

The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.

Contraindications 62 words

CONTRAINDICATIONS Silver Sulfadiazine Cream is contraindicated in patients who are hypersensitive to silver sulfadiazine or any of the other ingredients in the preparation. Because sulfonamide therapy is known to increase the possibility of kernicterus, Silver Sulfadiazine Cream should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life.

⚠️ Warnings 76 words

WARNING There is a potential cross-sensitivity between silver sulfadiazine and other sulfonamides. If allergic reactions attributable to treatment with silver sulfadiazine occur, continuation of therapy must be weighed against the potential hazards of the particular allergic reaction. Fungal proliferation in and below the eschar may occur.

However, the incidence of clinically reported fungal superinfection is low. The use of Silver Sulfadiazine Cream in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.

🤒 Adverse Reactions ~1 min read

ADVERSE REACTIONS Several cases of transient leucopenia have been reported in patients receiving silver sulfadiazine therapy. Leucopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count. Maximal white blood cell depression occurs within two to four days of initiation of therapy.

Rebound to normal leukocyte levels follows onset within two to three days. Recovery is not influenced by continuation of silver sulfadiazine therapy. The incidence of leucopenia in various reports averages about 20%.

A higher incidence has been seen in patients treated concurrently with cimetidine. Other infrequently occurring events include skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, and interstitial nephritis. Reduction in bacterial growth after application of topical antibacterial agents has been reported to permit spontaneous healing of deep partial thickness burns by preventing conversion of the partial thickness to full thickness by sepsis.

However, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture. Absorption of silver sulfadiazine varies depending upon the percent of body surface area and the extent of the tissue damage. Although few have been reported, it is possible that any adverse reaction associated with sulfonamides may occur.

Some of the reactions which have been associated with sulfonamides are as follows: blood dyscrasias, agranulocytosis, aplastic anemia, thrombocytopenia, leucopenia, hemolytic anemia, dermatologic reactions, allergic reactions, Stevens-Johnson syndrome, exfoliative dermatitis, gastrointestinal reactions, hepatitis, hepatocellular necrosis, CNS reactions, and toxic nephrosis.

🧬 Clinical Pharmacology ~1 min read

CLINICAL PHARMACOLOGY Silver sulfadiazine has broad antimicrobial activity. It is bactericidal for many gram-negative and gram-positive bacteria as well as being effective against yeast. Results from in vitro testing are listed below.

Sufficient data have been obtained to demonstrate that silver sulfadiazine will inhibit bacteria that are resistant to other antimicrobial agents and that the compound is superior to sulfadiazine. Studies utilizing radioactive micronized silver sulfadiazine, electron microscopy, and biochemical techniques have revealed that the mechanism of action of silver sulfadiazine on bacteria differs from silver nitrate and sodium sulfadiazine. Silver sulfadiazine acts only on the cell wall to produce its bactericidal effect.

Results of In Vitro Testing With Silver Sulfadiazine Cream, 1% Concentration of Silver Sulfadiazine Number of Sensitive Strains / Total Number of Strains Tested Genus and Species 50 micrograms/mL 100 micrograms/mL Pseudomonas Aeruginosa 130/130 130/130 Xanthomonas (Pseudomonas) Maltophilia 7/7 7/7 Enterobacter Species 48/50 50/50 Enterobacter cloacae 24/24 24/24 Klebsiella Species 53/54 54/54 Escherichia Coli 63/63 63/63 Serratia Species 27/28 28/28 Proteus Mirabilis 53/53 53/53 Morganella Morganii 10/10 10/10 Providencia Rettgeri 2/2 2/2 Proteus Vulgaris 2/2 2/2 Providencia Species 1/1 1/1 Citrobacter Species 10/10 10/10 Acinetobacter Calcoaceticus 10/11 11/11 Stahylococcus Aureus 100/101 101/101 Staphylococcus Epidermidis 51/51 51/51 B-Hemolytic Streptococcus 4/4 4/4 Enterococcus Species 52/53 53/53 Corynebacterium Diphtheriae 2/2 2/2 Clostridium Perfringens 0/2 2/2 Clostridium Perfringens 0/2 2/2 Candida Albicans 43/50 50/50 Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.

📦 How Supplied / Storage and Handling 92 words

HOW SUPPLIED SSD™ (1% Silver Sulfadiazine) Cream : white to off-white cream. 50 gram jar NDC 43598-210-55 400 gram jar NDC 43598-210-40 25 gram tube NDC 43598-210-25 50 gram tube NDC 43598-210-50 85 gram tube NDC 43598-210-85 SSD AF™ (1% Silver Sulfadiazine) Cream : white to off-white cream. 50 gram jar NDC 43598-211-55 400 gram jar NDC 43598-211-40 Store at controlled room temperature 15° - 30°C (59° - 86°F) SSD is a trademark of Dr.

Reddy's Laboratories, Inc. Manufactured by: Dr. Reddy's Laboratories Louisiana LLC Shreveport, LA 71106 USA Revised, June 2013

📋 Description 113 words

DESCRPITION SSD™ (1% Silver Sulfadiazine Cream) and SSD AF™ (1% Silver Sulfadiazine Cream), 1% are topical antibacterial preparations which have as their active antimicrobial ingredient silver sulfadiazine. The active moiety is contained within an opaque, white, water miscible cream base. Each 1000 grams of SSD/SSD AF Cream contains 10 grams of silver sulfadiazine.

Inactive Ingrediants: cetyl alcohol (SSD Cream only), isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methyl paraben, as a preservative. Silver sulfadiazine has an emprical formula of C 10 H 9 AgN 4 O 2 S, molecular weight of 357.14 and structural formula as shown: Structure for silver sulfadiazine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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