Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Ointment — NDC 51672-1272-01 package photo

Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Ointment

by Sun Pharmaceutical Industries, Inc. · 1 TUBE in 1 CARTON (51672-1272-1) / 15 g in 1 TUBE
NDC 51672-1272-01
🏷️ FDA NDC (as labeled) 51672-1272-1 billing pads the package segment with a zero
This package
Contains15 g in 1 tube Cost per g$0.3178 NADAC Per package$4.77 / 15 g Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.6795/unit · Part D plans $0.6475/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 10, 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) 51672-1272-1
Product NDC 51672-1272
11-digit billing NDC 51672127201
NCPDP billing unit GM — per gram (weight)
RxCUI 1053697, 1053753
UNII BDF1O1C72E, F446C597KA
Application # ANDA063305
SPL Set ID 2fd97fc5-cae5-43dd-a3c7-c9a03876153e
Established class (EPC) Polyene Antifungal; Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
Chemical class Polyenes
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1993-03-29
Route TOPICAL
Dosage form OINTMENT
Substance NYSTATIN; TRIAMCINOLONE ACETONIDE
GPI-14 90159902254200
GPI class Nystatin-Triamcinolone
GCN Seq No 048530
GCN 14008
HICL code 003161
Ingredient (HICL) Nystatin/Triamcinolone Acet
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 Q5F
Therapeutic class — specific (HIC3) Topical Antifungals
AHFS code 48:10.08.00
AHFS class Corticosteroids (Respiratory Tract)
FDB label name NYSTATIN-TRIAMCINOLONE OINTM
FDB brand name Nystatin-Triamcinolone
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 51672-1272-1 — a 5-4-1 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 package segment → 51672-1272-01. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids for local oral treatment, Corticosteroids, Corticosteroids, moderately potent (group II)
How it works Corticosteroid Hormone Receptor Agonists
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

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA063305 (ANDA)
Labeler code51672
First marketedMar 1993
Product typeHuman Prescription Drug
Portfolio889 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 NYSTATIN-TRIAMCINOLONE OINTM Ingredient Nystatin/Triamcinolone Acet
📖 What it is MedlinePlus · NLM

The combination of nystatin and triamcinolone is used to treat fungal skin infections. It relieves itching, inflammation, and pain. 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
  • This combination cream or ointment treats cutaneous candidiasis — a fungal skin infection caused by Candida yeast. The nystatin kills the yeast, and the triamcinolone steroid helps...
  • What exactly is this medication treating?
  • Apply it to the affected area twice a day — once in the morning and once in the evening. For the cream, massage it gently and thoroughly into the skin. For the ointment, apply a th...
  • Most people tolerate this medication well. You might notice some mild burning, stinging, or dryness at the spot where you apply it. Less commonly, some people see acne-like bumps o...
📖 Read our full Nystatin and Triamcinolone guide →
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 T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • 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.

2 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 $0.318 $4.77 / 15 g
Medicaid paysCMS SDUD · 12 mo $0.6795 $10.19 / 15 g
Medicare drug plans payPart D · Q2 2026 $0.6475 $9.71 / 15 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.477 $0.289
▼ Down 6% 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
Nystatin and triamcinolone acetonide 100000 [USP'U]/g; 1 mg/g 33342-0482-15 Macleods 1 tube $0.280 AT Availability likely save 12%
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 62332-0606-15 Alembic 1 tube $0.280 AT Availability likely save 12%
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 51672-1263-01 Sun 1 tube $0.280 AT Availability likely save 12%
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 68462-0799-17 Glenmark 1 tube $0.289 FDA listed save 9%
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 21922-0031-04 Encube 1 tube $0.318 AT Availability likely
Nystatin and triamcinolone acetonide 100000 [USP'U]/g; 1 mg/g 33342-0483-15 Macleods 1 tube $0.318 AT Availability likely
nystatin and triamcinolone acetonide 100000 [USP'U]/g; 1 mg/g 45802-0244-14 Padagis 1 tube $0.318 AT Availability likely
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/gthis 51672-1272-01 Sun 1 tube $0.318 AT Availability likely
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 62332-0585-15 Alembic 1 tube $0.318 AT Availability likely
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 72578-0088-01 Viona 1 tube $0.318 AT Availability likely
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 68180-0545-01 Lupin 1 tube $0.467 AT Discontinued +47%
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 68462-0314-17 Glenmark 1 tube $0.490 FDA listed +54%
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 63629-2495-01 Bryant 1 tube AT FDA listed
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 63629-2496-01 Bryant 1 tube AT FDA listed
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 63629-2497-01 Bryant 1 tube AT FDA listed
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 70771-1447-01 Zydus 1 tube AT FDA listed
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 71335-2847-01 Bryant 1 tube AT FDA listed
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 71335-2857-01 Bryant 1 tube AT FDA listed
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 72162-1275-02 Bryant 1 tube AT FDA listed
nystatin and triamcinolone acetonide 100000 [USP'U]/g; 1 mg/g 72162-1403-02 Bryant 1 tube AT FDA listed
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 13668-0610-01 Torrent 1 tube FDA listed
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 00316-0223-15 Crown 1 tube AT FDA listed
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 68071-5037-03 NuCare 30 g AT FDA listed
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 68788-8553-03 Preferred 1 tube AT Discontinued
Nystatin and triamcinolone acetonide 100000 [USP'U]/g; 1 mg/g 68071-3972-03 NuCare 1 tube AT FDA listed
Nystatin and triamcinolone acetonide 100000 [USP'U]/g; 1 mg/g 68788-8662-03 Preferred 1 tube AT FDA listed
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 68788-8808-03 Preferred 1 tube AT FDA listed
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 68788-8245-03 Preferred 1 tube FDA listed
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 46708-0606-15 Alembic 1 tube AT FDA listed
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 70518-1114-00 REMEDYREPACK 1 tube AT FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
1993
On the market since
Mar 1993
📍
2026
Currently FDA-listed
33 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 51672-1272-01, 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
229
Units reimbursed last 4 qtrs
4.8K
Gross reimbursed last 4 qtrs
$3.3K
Avg / prescription
$14.36
Avg / unit
$0.6795
Latest quarter Q4 2025
36Rx
Medicaid pays / g
$0.6795
gross reimbursed
vs
NADAC / g
$0.3178
acquisition cost
=
Spread
+$0.3617
+114% 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
57% FFS 43% MCO
Fee-for-service · 130 Rx Managed care · 99 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 2,546 units · 13.0 per 100k residents 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: no data reported OH Pennsylvania: 390 units · 3.0 per 100k residents PA New Jersey: 930 units · 10.0 per 100k residents 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: no data reported VA Maryland: no data reported 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: 975 units · 21.3 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: no data reported FL
Units reimbursed · per 100k residents
3.021.3
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 Louisiana 21.3 /100k
2 New York 13.0 /100k
3 New Jersey 10.0 /100k
4 Pennsylvania 3.0 /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.
1 tube51672-1272-02 201 Rx · $3,491
1 tube51672-1272-03 94 Rx · $2,006
Drug total (last 4 qtrs): 524 Rx · 17,081 units · $8,786 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 Nystatin and Triamcinolone Acetonide — the ingredient across all brands.

Top reported reactions

Application Site Pain8
Pruritus8
Drug Ineffective For Unapproved Indication6
Pain5
Rash5
Application Site Pruritus4
Burning Sensation4

Age at onset

Adult3
Elderly4

Reporter sex

104 reports

Serious outcomes

Hospitalization6
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 12 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
51672-1272-01 You're viewing this 1 TUBE in 1 CARTON (51672-1272-1) / 15 g in 1 TUBE $0.3178 / g $4.77 1993-03-29 Active
51672-1272-02 1 TUBE in 1 CARTON (51672-1272-2) / 30 g in 1 TUBE $0.2693 / g $8.08 1993-03-29 Active
51672-1272-03 1 TUBE in 1 CARTON (51672-1272-3) / 60 g in 1 TUBE $0.2266 / g $13.60 1993-03-29 Active

Per g, this pack runs about 40% above the cheapest pack (NDC 51672-1272-03, $0.2266 vs $0.3178 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 44% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 51672-1272-01?
NDC 51672-1272-01 is listed by the FDA — 1 tube in 1 carton / 15 g in 1 tube.
What NDC number is used to bill for this package of Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Ointment?
Bill NDC 51672-1272-01 — the 11-digit billing format is 51672127201. 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 41 words

INDICATIONS AND USAGE Nystatin and Triamcinolone Acetonide Cream and Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.

⏱️ Dosage and Administration 105 words

DOSAGE AND ADMINISTRATION Nystatin and Triamcinolone Acetonide Cream is usually applied to the affected areas twice daily in the morning and evening by gently and thoroughly massaging the preparation into the skin. The cream should be discontinued if symptoms persist after 25 days of therapy (see PRECAUTIONS, Laboratory Tests ). A thin film of Nystatin and Triamcinolone Acetonide Ointment is usually applied to the affected areas twice daily in the morning and evening.

The preparation should be discontinued if symptoms persist after 25 days of therapy (see PRECAUTIONS, Laboratory Tests ). Nystatin and Triamcinolone Acetonide Cream and Ointment should not be used with occlusive dressings.

Contraindications 18 words

CONTRAINDICATIONS These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.

🤒 Adverse Reactions 95 words

ADVERSE REACTIONS A single case (approximately one percent of patients studied) of acneiform eruption occurred with use of combined nystatin and triamcinolone acetonide in clinical studies. Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups, even during prolonged use. Rarely, irritation may occur.

The following local adverse reactions are reported infrequently with topical corticosteroids (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, perioral secondary infection, skin atrophy, striae and miliaria.

🤰 Pregnancy 88 words

Pregnancy Category C There are no teratogenic studies with combined nystatin and triamcinolone acetonide. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Therefore, any topical corticosteroid preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Topical preparations containing corticosteroids should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

🧒 Pediatric Use 147 words

Pediatric Use In clinical studies of a limited number of pediatric patients ranging from two months through 12 years, nystatin and triamcinolone acetonide cream formulation cleared or significantly ameliorated the disease state in most patients. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids.

Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen.

Chronic corticosteroid therapy may interfere with the growth and development of children.

🆘 Overdosage 30 words

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS, General ); however, acute overdosage and serious adverse effects with dermatologic use are unlikely.

🧬 Clinical Pharmacology ~1 min read

CLINICAL PHARMACOLOGY Nystatin Nystatin exerts its antifungal activity against a variety of pathogenic and nonpathogenic yeasts and fungi by binding to sterols in the cell membrane. The binding process renders the cell membrane incapable of functioning as a selective barrier. Nystatin provides specific anticandidal activity to Candida (Monilia) albicans and other Candida species, but is not active against bacteria, protozoa, trichomonads, or viruses.

Nystatin is not absorbed from intact skin or mucous membranes. Triamcinolone Acetonide Triamcinolone acetonide is primarily effective because of its anti-inflammatory, antipruritic and vasoconstrictive actions, characteristic of the topical corticosteroid class of drugs. The pharmacologic effects of the topical corticosteroids are well known; however, the mechanisms of their dermatologic actions are unclear.

Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics the extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (see DOSAGE AND ADMINISTRATION ).

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION ).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys.

Some of the topical corticosteroids and their metabolites are also excreted into the bile. Nystatin and Triamcinolone Acetonide During clinical studies of mild to severe manifestations of cutaneous candidiasis, patients treated with nystatin and triamcinolone acetonide showed a faster and more pronounced clearing of erythema and pruritus than patients treated with nystatin or triamcinolone acetonide alone.

📦 How Supplied / Storage and Handling 46 words

HOW SUPPLIED Nystatin and Triamcinolone Acetonide Cream is supplied in 15 g, 30 g, and 60 g tubes. Nystatin and Triamcinolone Acetonide Ointment is supplied in 15 g, 30 g, and 60 g tubes. STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid freezing.

📦 Storage and Handling 12 words

STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid freezing.

📋 Description 209 words

DESCRIPTION Nystatin and Triamcinolone Acetonide Cream and Ointment for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereallike odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol.

Structural formula: C 47 H 75 NO 17 MW = 926.13 Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula: C 24 H 31 FO 6 MW = 434.50 Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color.

Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an aqueous perfumed vanishing cream base with polysorbate-60, aluminum hydroxide, titanium dioxide, glyceryl monostearate, polyethylene glycol monostearate, simethicone emulsion, sorbic acid, propylene glycol, white petrolatum, polyoxyethylene fatty alcohol ether, methylparaben, propylparaben and sorbitol. Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum.

Chemical Structure Chemical Structure

💬 Information for Patients 153 words

Information for the Patient Patients using this medication should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occluded (see DOSAGE AND ADMINISTRATION ). Patients should report any signs of local adverse reactions.

When using this medication in the inguinal area, patients should be advised to apply the cream or ointment sparingly and to wear loose fitting clothing. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Patients should be advised on preventive measures to avoid reinfection.

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