HomeNDC LookupIngredientsTriamcinolone Acetonide › 33342-0331-15
Triamcinolone acetonide .25 mg/g Ointment — NDC 33342-0331-15 package photo

Triamcinolone acetonide .25 mg/g Ointment

by Macleods Pharmaceuticals Limited · 1 TUBE in 1 CARTON (33342-331-15) / 15 g in 1 TUBE
NDC 33342-0331-15
🏷️ FDA NDC (as labeled) 33342-331-15 billing pads the product segment with a zero
This package
Contains15 g in 1 tube Cost per g$0.2440 NADAC Per package$3.66 / 15 g Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.3653/unit · Part D plans $0.3820/unit — full pricing hub ↓
Rx only Generic 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 →
⚠️
Other active recalls for Triamcinolone Acetonide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 28, 2023 — Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial. (Eugia US LLC) · FDA recall D-0041-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 33342-331-15
Product NDC 33342-331
11-digit billing NDC 33342033115
NCPDP billing unit GM — per gram (weight)
UNII F446C597KA
UPC 0333342331540, 0333342331809, 0333342333803
Application # ANDA209828
SPL Set ID 4dc6fa38-0225-4b99-8cef-4fee72a30f90
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-11-23
Route TOPICAL
Dosage form OINTMENT
Substance TRIAMCINOLONE ACETONIDE
GPI-14 90550085104205
GPI class Triamcinolone Acetonide
GCN Seq No 007596
GCN 31241
HICL code 002891
Ingredient (HICL) Triamcinolone Acetonide
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 Q5P
Therapeutic class — specific (HIC3) Topical Anti-Inflammatory Steroidal
AHFS code 48:10.08.00
AHFS class Corticosteroids (Respiratory Tract)
FDB label name TRIAMCINOLONE 0.025% OINT
FDB brand name Triamcinolone Acetonide
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 33342-331-15 — 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 → 33342-0331-15. 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

LabelerMacleods Pharmaceuticals Limited
Application holderMACLEODS PHARMACEUTICALS LTD
FDA applicationANDA209828 (ANDA)
Labeler code33342
First marketedNov 2018
Product typeHuman Prescription Drug
Portfolio385 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 TRIAMCINOLONE 0.025% OINT Ingredient Triamcinolone Acetonide
📖 What it is MedlinePlus · NLM

Triamcinolone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). It is also used as a dental paste to relieve the discomfort of mouth sores. Triamcinolone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Yes, intra-articular triamcinolone is specifically approved to give short-term relief for knee arthritis, gout flares, bursitis, and similar joint conditions. The extended-release...
  • I'm getting a triamcinolone injection in my knee. Will it actually help, and how long does it last?
  • That's a really important thing to flag with your doctor before your injection or prescription. Triamcinolone can raise blood sugar — even in people whose diabetes is well-controll...
  • I have diabetes. Should I be worried about using triamcinolone?
📖 Read our full Triamcinolone guide →
8
Nutrient depletion considerations

Triamcinolone Acetonide may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 White
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 $0.244 $3.66 / 15 g
Medicaid paysCMS SDUD · 12 mo $0.3653 $5.48 / 15 g
Medicare drug plans payPart D · Q2 2026 $0.3820 $5.73 / 15 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.264 $0.224
▼ Down 2% 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
Triamcinolone Acetonide .25 mg/g 45802-0063-05 Padagis 454 g $0.036 AT Availability likely save 85%
Triamcinolone Acetonide .25 mg/g 45802-0054-05 Padagis 454 g $0.047 AT Availability likely save 81%
Triamcinolone Acetonide .25 mg/g 00168-0005-80 E. 80 g $0.076 AT Availability likely save 69%
Triamcinolone Acetonide .25 mg/g 00713-0226-15 Cosette 1 tube $0.116 AT Discontinued save 52%
Triamcinolone Acetonide .25 mg/g 16714-0985-01 NorthStar 1 tube $0.116 AT Availability likely save 52%
Triamcinolone Acetonide .25 mg/g 33342-0327-15 Macleods 1 tube $0.116 AT Availability likely save 52%
Triamcinolone Acetonide .25 mg/g 67877-0317-15 Ascend 15 g $0.116 AT Availability likely save 52%
triamcinolone acetonide .25 mg/g 00168-0003-15 E. 1 tube $0.116 AT Availability likely save 52%
Triamcinolone Acetonide .25 mg/g 00713-0229-15 Cosette 1 tube $0.244 AT Availability likely
Triamcinolone acetonide .25 mg/g 16714-0267-01 NorthStar 1 tube $0.244 AT Availability likely
Triamcinolone acetonide .25 mg/gthis 33342-0331-15 Macleods 1 tube $0.244 AT Availability likely
Triamcinolone Acetonide .25 mg/g 50090-3802-00 A-S 1 tube AT FDA listed
Triamcinolone Acetonide .25 mg/g 63629-8841-01 Bryant 80 g AT FDA listed
Triamcinolone Acetonide .25 mg/g 72162-2335-02 Bryant 1 tube AT FDA listed
Triamcinolone Acetonide .25 mg/g 76420-0360-80 Asclemed 80 g AT FDA listed
Triamcinolone Acetonide .25 mg/g 63187-0214-80 Proficient 80 g AT FDA listed
triamcinolone acetonide .25 mg/g 50090-0293-01 A-S 1 tube AT FDA listed
Triderm .25 mg/g 00316-0165-15 Crown 1 tube AT FDA listed
Triamcinolone Acetonide .25 mg/g 76420-0347-15 Asclemed 1 tube AT FDA listed
Triamcinolone Acetonide .25 mg/g 63629-8782-01 Bryant 15 g AT FDA listed
triamcinolone acetonide .25 mg/g 68788-8515-08 Preferred 1 tube AT FDA listed
Triamcinolone Acetonide .25 mg/g 68788-8899-01 Preferred 15 g AT FDA listed
Triamcinolone Acetonide .25 mg/g 72162-2334-02 Bryant 1 tube AT FDA listed
Triamcinolone Acetonide .25 mg/g 63629-8784-01 Bryant 454 g AT FDA listed
Triamcinolone acetonide .25 mg/g 68071-2361-01 NuCare 15 g AT FDA listed
Triamcinolone Acetonide .25 mg/g 50090-3704-00 A-S 1 tube AT FDA listed
Triamcinolone Acetonide .25 mg/g 71335-2870-01 Bryant 454 g AT FDA listed
Triamcinolone Acetonide .25 mg/g 50090-2658-00 A-S 15 g AT FDA listed
Triamcinolone Acetonide .25 mg/g 72162-1835-02 Bryant 454 g AT FDA listed
Triamcinolone Acetonide .25 mg/g 68788-4148-01 Preferred 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

🏛️
2018
On the market since
Nov 2018
📍
2026
Currently FDA-listed
8 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 33342-0331-15, 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
13.3K
Units reimbursed last 4 qtrs
367K
Gross reimbursed last 4 qtrs
$134.1K
Avg / prescription
$10.09
Avg / unit
$0.3653
Latest quarter Q4 2025
3.1KRx
Medicaid pays / g
$0.3653
gross reimbursed
vs
NADAC / g
$0.2440
acquisition cost
=
Spread
+$0.1213
+50% 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
47% FFS 53% MCO
Fee-for-service · 6,232 Rx Managed care · 7,051 Rx
State Medicaid map
Alaska: no data reported AK Maine: 3,855 units · 276 per 100k residents ME Washington: 4,265 units · 54.6 per 100k residents WA Idaho: 585 units · 29.8 per 100k residents ID Montana: 960 units · 84.8 per 100k residents MT North Dakota: no data reported ND Minnesota: 4,295 units · 74.9 per 100k residents MN Wisconsin: 3,795 units · 64.2 per 100k residents WI Michigan: 9,420 units · 93.9 per 100k residents MI New York: 115,700 units · 591 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 2,130 units · 50.3 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 990 units · 108 per 100k residents SD Iowa: 9,705 units · 303 per 100k residents IA Illinois: 2,490 units · 19.8 per 100k residents IL Indiana: 525 units · 7.7 per 100k residents IN Ohio: 7,425 units · 63.0 per 100k residents OH Pennsylvania: 30,875 units · 238 per 100k residents PA New Jersey: 16,625 units · 179 per 100k residents NJ Massachusetts: 5,325 units · 76.1 per 100k residents MA California: 27,990 units · 71.8 per 100k residents CA Utah: 780 units · 22.8 per 100k residents UT Colorado: 1,170 units · 19.9 per 100k residents CO Nebraska: 2,340 units · 118 per 100k residents NE Missouri: 6,015 units · 97.1 per 100k residents MO Kentucky: 3,020 units · 66.7 per 100k residents KY West Virginia: 375 units · 21.2 per 100k residents WV Virginia: 5,565 units · 63.8 per 100k residents VA Maryland: 13,928 units · 225 per 100k residents MD Connecticut: 4,725 units · 131 per 100k residents CT Rhode Island: no data reported RI Arizona: 270 units · 3.6 per 100k residents AZ New Mexico: 995 units · 47.1 per 100k residents NM Kansas: 480 units · 16.3 per 100k residents KS Arkansas: 540 units · 17.6 per 100k residents AR Tennessee: 4,211 units · 59.1 per 100k residents TN North Carolina: 6,945 units · 64.1 per 100k residents NC South Carolina: 4,035 units · 75.1 per 100k residents SC Delaware: no data reported DE Oklahoma: 2,190 units · 54.0 per 100k residents OK Louisiana: 4,605 units · 101 per 100k residents LA Mississippi: 840 units · 28.6 per 100k residents MS Alabama: 5,145 units · 101 per 100k residents AL Georgia: 18,769 units · 170 per 100k residents GA D.C.: 6,079 units · 895 per 100k residents DC Hawaii: no data reported HI Texas: 7,965 units · 26.1 per 100k residents TX Florida: 19,035 units · 84.2 per 100k residents FL
Units reimbursed · per 100k residents
3.6895
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 D.C. 895 /100k
2 New York 591 /100k
3 Iowa 303 /100k
4 Maine 276 /100k
5 Pennsylvania 238 /100k
6 Maryland 225 /100k
7 New Jersey 179 /100k
8 Georgia 170 /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 tube this page33342-0331-15 13,283 Rx · $134,073
1 tube33342-0331-80 9,594 Rx · $127,177
454 gs33342-0331-54 2,536 Rx · $69,450
Drug total (last 4 qtrs): 25,413 Rx · 2,239,178 units · $330,700 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 Triamcinolone Acetonide — the program that covers self-administered drugs. 22 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 Triamcinolone Acetonide. 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
$17.79M
Claims incl. refills
1.7M
Beneficiaries
1.4M
Spend / beneficiary
$13.01
Spend / claim
$10.45
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 Triamcinolone Acetonide — the ingredient across all brands.

Top reported reactions

Pruritus2,650
Rash2,534
Pain2,232
Fatigue2,133
Nausea2,043
Headache1,916
Condition Aggravated1,747

Reporter sex

31,697 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization6,577
Death3,076
Disabling2,415
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,201 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
33342-0331-15 You're viewing this 1 TUBE in 1 CARTON (33342-331-15) / 15 g in 1 TUBE $0.2440 / g $3.66 2018-11-23 Active
33342-0331-54 454 g in 1 JAR (33342-331-54) $0.0472 / g $21.43 2018-11-23 Active
33342-0331-80 1 TUBE in 1 CARTON (33342-331-80) / 80 g in 1 TUBE $0.0763 / g $6.10 2018-11-23 Active

Per g, this pack runs about 417% above the cheapest pack (454 g, $0.0472 vs $0.2440 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 52% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 33342-0331-15?
NDC 33342-0331-15 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 Triamcinolone acetonide .25 mg/g Ointment?
Bill NDC 33342-0331-15 — the 11-digit billing format is 33342033115. 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 21 words

INDICATIONS & USAGE Triamcinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

⏱️ Dosage and Administration 198 words

DOSAGE & ADMINISTRATION Apply a thin film of Triamcinolone Acetonide Ointment 0.025% to the affected area two to four times daily. Apply a thin film of the 0.1% or the 0.5% Triamcinolone Acetonide Ointment, as appropriate, to the affected area two to three times daily. Occlusive Dressing Technique Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions.

Apply a thin film of ointment to the lesion, cover with a pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis.

It may be convenient to apply Triamcinolone Acetonide Ointment under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional ointment should be applied, without occlusion, during the day. Reapplication is essential at each dressing change.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Contraindications 21 words

CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

🤒 Adverse Reactions 59 words

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings (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.

🤰 Pregnancy 94 words

Pregnancy: Teratogenic Effects Category C. 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.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

🧒 Pediatric Use 114 words

Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid induced 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 18 words

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS, General ).

🧬 Clinical Pharmacology 192 words

CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is 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. 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. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (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.

📦 How Supplied / Storage and Handling 130 words

HOW SUPPLIED Triamcinolone Acetonide Ointment USP, 0.025% is available as follows: 15 gram tubes NDC 33342-331-15 80 gram tubes NDC 33342-331-80 454 g jar NDC 33342-331-54 Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 gram tubes NDC 33342-333-15 80 gram tubes NDC 33342-333-80 454 g jar NDC 33342-333-54 Triamcinolone Acetonide Ointment USP, 0.5% is available as follows: 15 gram tubes NDC 33342-332-15 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufacturer: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh, INDIA To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc.at 1-888-943-3210 or 1-855-926- 3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Revised: July 2023

📋 Description 77 words

DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. 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 structural formula is: Each gram of Triamcinolone Acetonide Ointment USP, 0.025%, 0.1% or 0.5% contains 0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum. str

💬 Information for Patients 127 words

Information for the Patient Patients using topical corticosteroids 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 occlusive unless directed by the physician. 4.

Patients should report any signs of local adverse reactions especially under occlusive dressing. 5. 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.

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