![Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Ointment — NDC 21922-0031-05 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d33829fc-86df-4e28-82c3-9dbcd8a9e28d&name=15g+-+carton.jpg)
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Ointment
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- 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...
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.269 | $8.08 / 30 g |
| Medicaid paysCMS SDUD · 12 mo | $0.5492 | $16.48 / 30 g |
| Medicare drug plans payPart D · Q2 2026 | $0.6475 | $19.43 / 30 g |
Where does this data come from?
🔁 Therapeutic equivalents
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 21922-0031-04 | 1 TUBE in 1 CARTON (21922-031-04) / 15 g in 1 TUBE | $0.3178 / g | $4.77 | 2019-09-28 | Active |
| 21922-0031-05 You're viewing this | 1 TUBE in 1 CARTON (21922-031-05) / 30 g in 1 TUBE | $0.2693 / g | $8.08 | 2019-09-28 | Active |
| 21922-0031-07 | 1 TUBE in 1 CARTON (21922-031-07) / 60 g in 1 TUBE | $0.2266 / g | $13.60 | 2019-09-28 | Active |
Per g, this pack runs about 19% above the cheapest pack (NDC 21922-0031-07, $0.2266 vs $0.2693 NADAC).
This pack accounts for about 43% of this product's recent Medicaid fills; the largest share goes to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 21922-0031-05?
What NDC number is used to bill for this package of Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Ointment?
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
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Nystatin and Triamcinolone Acetonide Ointment, USP is 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 ▾
DOSAGE AND ADMINISTRATION A thin film of Nystatin and Triamcinolone Acetonide Ointment, USP 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 Ointment, USP should not be used with occlusive dressings.
⛔ Contraindications ▾
CONTRAINDICATIONS These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.
🤒 Adverse Reactions ▾
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 non sensitizing 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 ▾
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 lo 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 ▾
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 bodyweight 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 ▾
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 ▾
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 ▾
HOW SUPPLIED Nystatin and Triamcinolone Acetonide Ointment, USP is supplied in 15g (NDC 21922-031-04), 30g (NDC 21922-031-05) and 60g (NDC 21922-031-07) tubes. STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid freezing.
To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-844-369-4671 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Rx only Manufactured by: Encube Ethicals Pvt. Ltd.
Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc.
200 Meredith Drive, Suite 202, Durham, NC 27713, USA Rev 01 November 2022
📋 Description ▾
DESCRIPTION Nystatin and Triamcinolone Acetonide Ointment, USP for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin, USP is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereallike odor, slightly soluble in methanol, and freely soluble in dimethylformamide, dimethyl sulfoxide, and practically insoluble in n -propyl alcohol, n -bulyl alcohol,water, alcohol, chloroform, ether.
Structural formula: Triamcinolone acetonide, USP is designated chemically as 9-fluoro-11β,16a, 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 sparingly soluble in dehydrated alcohol, chloroform, and slightly soluble in methanol. Structural formula: Each gram of Nystatin and Triamcinolone Acetonide Ointment, USP provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum. structure-nyst structure-triam
💬 Information for Patients ▾
Information for the Patient Patients using this medication should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only.
Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occluded (see DOSAGE AND ADMINISTRATION ). 4.
Patients should report any signs of local adverse reactions. 5. When using this medication in the inguinal area, patients should be advised to apply the ointment sparingly and to wear loose fitting clothing.
6. Parents of pediatric patients should be advised not to use light-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. 7.
Patients should be advised on preventive measures to avoid reinfection.