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triamcinolone acetonide .25 mg/g Cream — NDC 00168-0003-80 package photo

triamcinolone acetonide .25 mg/g Cream

by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC · 1 TUBE in 1 CARTON (0168-0003-80) / 80 g in 1 TUBE
NDC 00168-0003-80
🏷️ FDA NDC (as labeled) 0168-0003-80 billing pads the labeler segment with a zero
This package
Contains80 g in 1 tube Cost per g$0.0532 NADAC Per package$4.26 / 80 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.1363/unit · Part D plans $0.1230/unit — full pricing hub ↓
Also comes in: 15 g 00168-0003-15
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 ↗
Past resolved recalls for this product (1)
Class II · Apr 13, 2022 · Terminated — cGMP deviations: Temperature abuse (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1106-2022

🆔 Identity & classification

FDA NDC (as labeled) 0168-0003-80
Product NDC 0168-0003
11-digit billing NDC 00168000380
NCPDP billing unit GM — per gram (weight)
UNII F446C597KA
UPC 0301680004150, 0301680003153, 0301680002156
Application # ANDA085692
SPL Set ID 92a1ded0-8e1a-4994-9c8a-89e84fc85c94
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 1978-03-09
Route TOPICAL
Dosage form CREAM
Substance TRIAMCINOLONE ACETONIDE
GPI-14 90550085103705
GPI class Triamcinolone Acetonide
GCN Seq No 007593
GCN 31231
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% CREAM
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 0168-0003-80 — a 4-4-2 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 labeler segment → 00168-0003-80. 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

LabelerE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application holderFOUGERA PHARMACEUTICALS INC
FDA applicationANDA085692 (ANDA)
Labeler code00168
First marketedMar 1978
Product typeHuman Prescription Drug
Portfolio33 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% CREAM 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
  • Triamcinolone cream and ointment are used for a wide range of inflammatory skin conditions — things like eczema, contact dermatitis, psoriasis, and other rashes that cause redness...
  • What skin problems does this cream actually treat?
  • The key word is 'thin film.' You only need enough to lightly cover the affected area — rubbing in a thick layer does not help more and increases the risk of side effects. Apply it...
  • How do I apply it — and how much is too much?
📖 Read our full Triamcinolone Topical 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.

🧪 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 8CRQ2TH63M
    Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 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 DailyMed — ingredient 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 $0.053 $4.26 / 80 g
Medicaid paysCMS SDUD · 12 mo $0.1363 $10.90 / 80 g
Medicare drug plans payPart D · Q2 2026 $0.1230 $9.84 / 80 g
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.076 $0.052
▼ Down 30% 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 $0.035 AT Availability likely save 34%
Triamcinolone Acetonide .25 mg/g 45802-0054-05 Padagis 454 g $0.047 AT Availability likely save 11%
triamcinolone acetonide .25 mg/gthis 00168-0003-80 E. 1 tube $0.053 AT Availability likely —
Triamcinolone Acetonide .25 mg/g 00168-0005-80 E. 80 g $0.074 AT Availability likely +39%
Triamcinolone Acetonide .25 mg/g 00713-0226-15 Cosette 1 tube $0.120 AT Discontinued +125%
Triamcinolone Acetonide .25 mg/g 16714-0985-01 NorthStar 1 tube $0.120 AT Availability likely +125%
Triamcinolone Acetonide .25 mg/g 33342-0327-15 Macleods 1 tube $0.120 AT Availability likely +125%
Triamcinolone Acetonide .25 mg/g 67877-0317-15 Ascend 15 g $0.120 AT Availability likely +125%
Triamcinolone acetonide .25 mg/g 33342-0331-15 Macleods 1 tube $0.239 AT Availability likely +350%
Triamcinolone Acetonide .25 mg/g 00713-0229-15 Cosette 1 tube $0.239 AT Availability likely +350%
Triamcinolone acetonide .25 mg/g 16714-0267-01 NorthStar 1 tube $0.239 AT Availability likely +350%
Triderm .25 mg/g 00316-0165-15 Crown 1 tube — AT FDA listed —
triamcinolone acetonide .25 mg/g 50090-0293-01 A-S 1 tube — AT FDA listed —
Triamcinolone Acetonide .25 mg/g 50090-2658-00 A-S 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 63187-0214-80 Proficient 80 g — AT FDA listed —
Triamcinolone Acetonide .25 mg/g 63629-8782-01 Bryant 15 g — 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 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 71335-2870-01 Bryant 454 g — AT FDA listed —
Triamcinolone Acetonide .25 mg/g 72162-1835-02 Bryant 454 g — AT FDA listed —
Triamcinolone Acetonide .25 mg/g 72162-2334-02 Bryant 1 tube — AT FDA listed —
Triamcinolone Acetonide .25 mg/g 76420-0347-15 Asclemed 1 tube — AT FDA listed —
Triamcinolone Acetonide .25 mg/g 76420-0360-80 Asclemed 80 g — 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 50090-3802-00 A-S 1 tube — 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

🏛️
1978
On the market since
Mar 1978
📍
2026
Currently FDA-listed
48 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 00168-0003-80, 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
17.1K
Units reimbursed last 4 qtrs
1.4M
Gross reimbursed last 4 qtrs
$189.9K
Avg / prescription
$11.12
Avg / unit
$0.1363
Latest quarter Q4 2025
3.6KRx
Medicaid pays / g
$0.1363
gross reimbursed
vs
NADAC / g
$0.0532
acquisition cost
=
Spread
+$0.0831
+156% 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 ⓘ
44% FFS 56% MCO
Fee-for-service · 7,449 Rx Managed care · 9,629 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 14,080 units · 180 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: 6,350 units · 811 per 100k residents ND Minnesota: 15,040 units · 262 per 100k residents MN Wisconsin: 8,120 units · 137 per 100k residents WI Michigan: 93,413 units · 931 per 100k residents MI New York: 418,480 units · 2,138 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 3,680 units · 86.9 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 7,380 units · 803 per 100k residents SD Iowa: 8,640 units · 269 per 100k residents IA Illinois: 40,381 units · 322 per 100k residents IL Indiana: 70,125 units · 1,022 per 100k residents IN Ohio: 103,880 units · 881 per 100k residents OH Pennsylvania: 113,225 units · 874 per 100k residents PA New Jersey: 13,985 units · 151 per 100k residents NJ Massachusetts: 8,000 units · 114 per 100k residents MA California: 81,689 units · 210 per 100k residents CA Utah: 2,590 units · 75.8 per 100k residents UT Colorado: 5,440 units · 92.5 per 100k residents CO Nebraska: 910 units · 46.0 per 100k residents NE Missouri: 21,935 units · 354 per 100k residents MO Kentucky: 21,026 units · 465 per 100k residents KY West Virginia: 16,000 units · 904 per 100k residents WV Virginia: 17,425 units · 200 per 100k residents VA Maryland: 51,545 units · 834 per 100k residents MD Connecticut: 2,640 units · 73.0 per 100k residents CT Rhode Island: no data reported RI Arizona: 4,480 units · 60.3 per 100k residents AZ New Mexico: 2,750 units · 130 per 100k residents NM Kansas: 1,840 units · 62.6 per 100k residents KS Arkansas: 11,040 units · 360 per 100k residents AR Tennessee: 10,920 units · 153 per 100k residents TN North Carolina: 20,335 units · 188 per 100k residents NC South Carolina: 4,635 units · 86.3 per 100k residents SC Delaware: no data reported DE Oklahoma: 15,815 units · 390 per 100k residents OK Louisiana: 39,044 units · 854 per 100k residents LA Mississippi: 8,860 units · 301 per 100k residents MS Alabama: 6,365 units · 125 per 100k residents AL Georgia: 13,710 units · 124 per 100k residents GA D.C.: 5,540 units · 816 per 100k residents DC Hawaii: no data reported HI Texas: 74,840 units · 245 per 100k residents TX Florida: 27,280 units · 121 per 100k residents FL
Units reimbursed · per 100k residents
46.02,138
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 New York 2,138 /100k
2 Indiana 1,022 /100k
3 Michigan 931 /100k
4 West Virginia 904 /100k
5 Ohio 881 /100k
6 Pennsylvania 874 /100k
7 Louisiana 854 /100k
8 Maryland 834 /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 tube00168-0003-15 29,719 Rx · $249,329
1 tube this page00168-0003-80 17,078 Rx · $189,948
Drug total (last 4 qtrs): 46,797 Rx · 2,224,009 units · $439,277 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
00168-0003-15 1 TUBE in 1 CARTON (0168-0003-15) / 15 g in 1 TUBE $0.1198 / g $1.80 1978-03-09 Active
00168-0003-80 You're viewing this 1 TUBE in 1 CARTON (0168-0003-80) / 80 g in 1 TUBE $0.0532 / g $4.26 1978-03-09 Active

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.0532 NADAC).

This pack accounts for about 36% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 00168-0003-80?
NDC 00168-0003-80 is listed by the FDA — 1 tube in 1 carton / 80 g in 1 tube.
What NDC number is used to bill for this package of triamcinolone acetonide .25 mg/g Cream?
Bill NDC 00168-0003-80 — the 11-digit billing format is 00168000380. 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 19 words ▾

INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

⏱️ Dosage and Administration 73 words ▾

DOSAGE AND ADMINISTRATION: Apply to the affected area as a thin film as follows: Triamcinolone Acetonide Cream USP, 0.025% two to four times daily; Triamcinolone Acetonide Cream USP, 0.1% and 0.5% two or three times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. 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 preparation.

🤒 Adverse Reactions 60 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. These 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 92 words ▾

Pregnancy 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. Hypothalamic-pituitary-adrenal (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 17 words ▾

OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS ).

🧬 Clinical Pharmacology 192 words ▾

CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, anti-pruritic 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 83 words ▾

HOW SUPPLIED: Triamcinolone Acetonide Cream USP, 0.025% Triamcinolone Acetonide Cream USP, 0.1% 15 gram tubes NDC 0168-0003-15 15 gram tubes NDC 0168-0004-15 80 gram tubes NDC 0168-0003-80 80 gram tubes NDC 0168-0004-80 1 Lb jars NDC 0168-0004-16 Triamcinolone Acetonide Cream USP, 0.5% 15 gram tubes NDC 0168-0002-15. Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat.

Protect from freezing. Fougera PHARMACEUTICALS INC. E.

FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville New York 11747 I20215G/IF20215G R09/11 #227 46165001A R06/15 #65

📋 Description 128 words ▾

DESCRIPTION: Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24 H 31 FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.

Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. chemstructure

💬 Information for Patients 128 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 ↗
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.