Mediclarum
Medicine guide

Nystatin and Triamcinolone Acetonide

100000 [USP'U]/g + 1 mg/g · Cream

  • Prescription only
  • Corticosteroid
Made by
Padagis Israel Pharmaceuticals Ltd

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 · 2023-03-01

What it is

Corticosteroid

Used for
  • Nystatin and Triamcinolone Acetonide Cream is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin…
Do not take it if

This preparation is contraindicated in those patients with a history of hypersensitivity to any of its 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
2other products contain Nystatin, 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 Cream 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 · 2023-03-01 · 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 · 2023-03-01

Do not take it if

This preparation is contraindicated in those patients with a history of hypersensitivity to any of its 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.

  • 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).
  • Nystatin and Triamcinolone Acetonide Cream 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.
  • 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.
  • Nursing Mothers:
  • Pediatric Use:
  • 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

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 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.

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 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, secondary infection, skin atrophy, striae and miliaria.
  • To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

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 cream sparingly and to wear loose fitting clothing. 6.
  • 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. 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 Cream is supplied in 15 g (NDC 45802-880-14), 30 g (NDC 45802-880-94) and 60 g (NDC 45802-880-96) tubes.
  • STORAGE: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
  • Avoid freezing.
  • Manufactured by Padagis ® Yeruham, Israel www.padagis.com Rev 03-23 7M900 RC PH3

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

What is in it

  • Nystatin and Triamcinolone Acetonide Cream for dermatologic use contains 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 cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol.
  • Structural formula: C 47 H 75 N0 17 MW =
  • 926.13 Triamcinolone acetonide is designated chemically as 9-fluoro-11ß, 16ɑ, 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 F0 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 a cream base with aluminum hydroxide, cetearyl alcohol and ceteareth 20, glyceryl monostearate, methylparaben, polyethylene glycol monostearate, polysorbate 60, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium hydroxide, sorbic acid, sorbitol, titanium dioxide, and white petrolatum. structural formula 1.jpg structural formula 2.jpg

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 byPadagis Israel Pharmaceuticals Ltd
Active substanceNystatin, Triamcinolone Acetonide
Used inAntibiotics, antivirals and antifungals taken into the body
Strength100000 [USP'U]/g + 1 mg/g
FormCream
RouteTopical
Packs1 TUBE in 1 CARTON / 15 g in 1 TUBE · 1 TUBE in 1 CARTON / 30 g in 1 TUBE
NDC45802-880

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).

Report wrong or outdated information on this page

Other strengths and forms

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

Same active substance

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

Nystatin and Triamcinolone Acetonide100000 [USP'U]/g + 1 mg/gPrescription onlyCream Bryant Ranch Prepack · Nystatin, Triamcinolone AcetonideNystatin and Triamcinolone Acetonide100000 [USP'U]/g + 1 mg/gPrescription onlyCream NuCare Pharmaceuticals,Inc. · Nystatin, Triamcinolone Acetonide

See every product with Nystatin, Triamcinolone Acetonide