Medicine guide

Nystatin and Triamcinolone Acetonide

100000 [USP'U]/g + 1 mg/g · Ointment

Prescription only
Corticosteroid

Active substance: Nystatin and Triamcinolone Acetonide
Used in: Antibiotics, antivirals and antifungals taken into the body
Made by: Bryant Ranch Prepack
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2024-08-20

What it is

Corticosteroid

Used for

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…

Do not take it if

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

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

20other products contain Nystatin and Triamcinolone Acetonide — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

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.

From the official label · 2024-08-20 · DailyMed

How it works

From this product’s own US prescribing label.

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.

How the body breaks it down

Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-08-20

Do not take it if

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

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions that augment systemic absorption include application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings (see DOSAGE AND ADMINISTRATION ).
Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and for impairment of internal homeostasis.
If HPA axis suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, or substitute a less potent steroid.
Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug.
Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use ).
If irritation or hypersensitivity develops with the combination nystatin and triamcinolone acetonide, treatment should be discontinued and appropriate therapy instituted.
1.
Laboratory Tests If there is a lack of therapeutic response, appropriate microbiological studies (e.g.
KOH smears and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens, before instituting another course of therapy.
A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating hypothalamic-pituitary-adrenal (HPA) axis suppression due to corticosteroids.
Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females.
Pregnancy Category C There are no teratogenic studies with combined nystatin and triamcinolone acetonide.
Nursing Mothers It is not known whether any component of this preparation is excreted in human milk.
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.
General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions that augment systemic absorption include application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings (see DOSAGE AND ADMINISTRATION ).
Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and for impairment of internal homeostasis.
If HPA axis suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, or substitute a less potent steroid.
Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug.
Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use ).
If irritation or hypersensitivity develops with the combination nystatin and triamcinolone acetonide, treatment should be discontinued and appropriate therapy instituted.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

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.
It is not known whether any component of this preparation is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised during the use of this preparation by a nursing woman.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

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.

Quoted from the official label, section “Overdosage”.

Use in children

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.

Quoted from the official label, section “Pediatric Use”.

Side effects

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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

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.

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

Nystatin and Triamcinolone Acetonide Ointment, USP is supplied in 60g (NDC 63629-2495-1) tubes. STORAGE
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Avoid freezing. Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc. Burbank, CA 91504

Quoted from the official label, section “How Supplied”.

What is in it

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.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (24)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 24 of 24

Details

Made by	Bryant Ranch Prepack
Active substance	Nystatin and Triamcinolone Acetonide
Used in	Antibiotics, antivirals and antifungals taken into the body
Strength	100000 [USP'U]/g + 1 mg/g
Form	Ointment
Route	Topical
Packs	1 TUBE in 1 CARTON / 60 g in 1 TUBE · 1 TUBE in 1 CARTON / 30 g in 1 TUBE · 1 TUBE in 1 CARTON / 15 g in 1 TUBE
NDC	63629-2495
NDC	63629-2496

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

24 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Cream15 products
- 100000 [USP'U]/g + 1 mg/g15
  100000 [USP'U]/g + 1 mg/g · 15 companies
  +7 more
Ointment9 products
- 100000 [USP'U]/g + 1 mg/g9
  100000 [USP'U]/g + 1 mg/g · 9 companies
  - Alembic Pharmaceuticals Inc.
  - Bryant Ranch Prepack · this page
  - Encube Ethicals, Inc.
  - Glenmark Pharmaceuticals Inc., USA
  - Macleods Pharmaceuticals Limited
  - Padagis Israel Pharmaceuticals Ltd
  - Sun Pharmaceutical Industries, Inc.
  - Viona Pharmaceuticals Inc
  +1 more

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Nystatin and Triamcinolone Acetonide