HomeNDC LookupIngredientsTriamcinolone Acetonide › 00713-0655-40
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Triamcinolone Acetonide 1 mg/g Paste

by Cosette Pharmaceuticals, Inc. · 1 TUBE in 1 CARTON (0713-0655-40) / 5 g in 1 TUBE
NDC 00713-0655-40
🏷️ FDA NDC (as labeled) 0713-0655-40 billing pads the labeler segment with a zero
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) 0713-0655-40
Product NDC 0713-0655
11-digit billing NDC 00713065540
NCPDP billing unit GM — per gram (weight)
RxCUI 1085728
UNII F446C597KA
UPC 0307130655408
Application # ANDA205592
SPL Set ID d2095a36-3fcf-7c20-95e5-e046b014565f
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 2017-01-13
Route DENTAL
Dosage form PASTE
Substance TRIAMCINOLONE ACETONIDE
GPI-14 88250020104410
GPI class Triamcinolone Acetonide
GCN Seq No 002599
GCN 31870
HICL code 002891
Ingredient (HICL) Triamcinolone Acetonide
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D1
Therapeutic class — intermediate (HIC2) Dental Preparations
HIC3 code D1D
Therapeutic class — specific (HIC3) Dental Aids And Preparations
AHFS code 48:10.08.00
AHFS class Corticosteroids (Respiratory Tract)
FDB label name TRIAMCINOLONE 0.1% PASTE
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 0713-0655-40 — 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 → 00713-0655-40. 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

LabelerCosette Pharmaceuticals, Inc.
Application holderCOSETTE PHARMACEUTICALS NC LABORATORIES LLC
FDA applicationANDA205592 (ANDA)
Labeler code00713
First marketedJan 2017
Product typeHuman Prescription Drug
Portfolio99 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 0.1% PASTE Ingredient Triamcinolone Acetonide
📖 What it is MedlinePlus · NLM

Triamcinolone, a corticosteroid, is similar to a natural hormone produced by your adrenal glands. It often is used to replace this chemical when your body does not make enough of it. It relieves inflammation (swelling, heat, redness, and pain) and is used to treat certain forms of arthritis; skin, blood, kidney, eye, thyroid, and intestinal disorders (e.g., colitis); severe allergies; and asthma. Triamcinolone is also used to treat certain types of cancer. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

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 brown
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 K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII UG00KM4WR7
    A plastic polymer used as a container material and film coating. It helps protect the medicine from moisture and air exposure during storage and shipping.
  • 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 89NA02M4RX
    Pectin is a natural fiber extracted from fruit and plants. It's used in medicines as a thickener, binder, and gelling agent to create the right texture and help the product hold together.

5 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 $2.686 $13.43 / 5 g
Medicaid paysCMS SDUD · 12 mo $4.50 $22.51 / 5 g
Medicare drug plans payPart D · Q2 2026 $4.56 $22.81 / 5 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $5.567 $2.686
▼ Down 48% 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 1 mg/gthis 00713-0655-40 Cosette 1 tube $2.686 AT Availability likely
Triamcinolone Acetonide 1 mg/g 51672-1267-05 Sun 1 tube $2.686 AT Availability likely
Triamcinolone Acetonide 1 mg/g 64980-0320-05 Rising 1 tube $2.686 AT Availability likely
Oralone 1 mg/g 51672-1335-05 Sun 1 tube $2.789 AT FDA listed +4%
Triamcinolone Acetonide 1 mg/g 68788-7814-05 Preferred 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 68788-8386-05 Preferred 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 68788-8841-05 Preferred 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 70752-0140-16 QUAGEN 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 72162-2318-02 Bryant 1 tube AT FDA listed
Kourzeq 1 mg/g 82682-0001-05 MidAmerica 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

🏛️
2017
On the market since
Jan 2017
📍
2026
Currently FDA-listed
9 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 00713-0655-40, 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
22.3K
Units reimbursed last 4 qtrs
128.8K
Gross reimbursed last 4 qtrs
$579.5K
Avg / prescription
$25.94
Avg / unit
$4.5010
Latest quarter Q4 2025
5KRx
Medicaid pays / g
$4.5010
gross reimbursed
vs
NADAC / g
$2.6861
acquisition cost
=
Spread
+$1.8149
+68% 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
58% FFS 42% MCO
Fee-for-service · 12,978 Rx Managed care · 9,360 Rx
State Medicaid map
Alaska: 105 units · 14.3 per 100k residents AK Maine: 140 units · 10.0 per 100k residents ME Washington: 3,810 units · 48.8 per 100k residents WA Idaho: 425 units · 21.6 per 100k residents ID Montana: 240 units · 21.2 per 100k residents MT North Dakota: 60 units · 7.7 per 100k residents ND Minnesota: 515 units · 9.0 per 100k residents MN Wisconsin: 1,230 units · 20.8 per 100k residents WI Michigan: 6,006 units · 59.8 per 100k residents MI New York: 50,684 units · 259 per 100k residents NY Vermont: 125 units · 19.3 per 100k residents VT New Hampshire: no data reported NH Oregon: 745 units · 17.6 per 100k residents OR Nevada: 610 units · 19.1 per 100k residents NV Wyoming: no data reported WY South Dakota: 140 units · 15.2 per 100k residents SD Iowa: 465 units · 14.5 per 100k residents IA Illinois: 1,530 units · 12.2 per 100k residents IL Indiana: 790 units · 11.5 per 100k residents IN Ohio: 2,130 units · 18.1 per 100k residents OH Pennsylvania: 3,480 units · 26.8 per 100k residents PA New Jersey: 995 units · 10.7 per 100k residents NJ Massachusetts: 505 units · 7.2 per 100k residents MA California: 15,472 units · 39.7 per 100k residents CA Utah: 545 units · 15.9 per 100k residents UT Colorado: 845 units · 14.4 per 100k residents CO Nebraska: no data reported NE Missouri: 1,395 units · 22.5 per 100k residents MO Kentucky: 2,110 units · 46.6 per 100k residents KY West Virginia: 800 units · 45.2 per 100k residents WV Virginia: 2,530 units · 29.0 per 100k residents VA Maryland: 1,085 units · 17.6 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 1,215 units · 16.4 per 100k residents AZ New Mexico: 580 units · 27.4 per 100k residents NM Kansas: 60 units · 2.0 per 100k residents KS Arkansas: 835 units · 27.2 per 100k residents AR Tennessee: 1,040 units · 14.6 per 100k residents TN North Carolina: 2,735 units · 25.2 per 100k residents NC South Carolina: 1,090 units · 20.3 per 100k residents SC Delaware: no data reported DE Oklahoma: 1,065 units · 26.3 per 100k residents OK Louisiana: 1,045 units · 22.8 per 100k residents LA Mississippi: 1,475 units · 50.2 per 100k residents MS Alabama: 1,800 units · 35.2 per 100k residents AL Georgia: 2,630 units · 23.8 per 100k residents GA D.C.: no data reported DC Hawaii: 270 units · 18.8 per 100k residents HI Texas: 8,875 units · 29.1 per 100k residents TX Florida: 4,530 units · 20.0 per 100k residents FL
Units reimbursed · per 100k residents
2.0259
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 259 /100k
2 Michigan 59.8 /100k
3 Mississippi 50.2 /100k
4 Washington 48.8 /100k
5 Kentucky 46.6 /100k
6 West Virginia 45.2 /100k
7 California 39.7 /100k
8 Alabama 35.2 /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.

📊 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 Marketing startStatus
00713-0655-40 You're viewing this 1 TUBE in 1 CARTON (0713-0655-40) / 5 g in 1 TUBE 2017-01-13 Active

📄 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 32 words

INDICATIONS AND USAGE Triamcinolone Acetonide Dental Paste, USP 0.1% is indicated for adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.

⏱️ Dosage and Administration 126 words

DOSAGE AND ADMINISTRATION Press a small dab (about ¼ inch) to the lesion until a thin film develops. A larger quantity may be required for coverage of some lesions. For optimal results use only enough to coat the lesion with a thin film.

Do not rub in. Attempting to spread this preparation may result in granular, gritty sensation and cause it to crumble. After application, however, a smooth, slippery film develops.

The preparation should be applied at bedtime to permit steroid contact with the lesion throughout the night. Depending on the severity of symptoms, it may be necessary to apply the preparation two or three times a day, preferably after meals. If significant repair or regeneration has not occurred in seven days, further investigation is advisable.

Contraindications 41 words

CONTRAINDICATIONS Triamcinolone acetonide dental paste is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation; it is also contraindicated in the presence of fungal, viral, or bacterial infections of the mouth or throat.

🤒 Adverse Reactions 70 words

ADVERSE REACTIONS The following local adverse reactions may occur with corticosteroid-containing dental pastes: burning, itching, irritation, dryness, blistering or peeling not present prior to therapy, perioral dermatitis, allergic contact dermatitis, maceration of the oral mucosa, secondary infection, and atrophy of the oral mucosa. Also, see PRECAUTIONS for potential effects of systemic absorption. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🤰 Pregnancy 190 words

Pregnancy Category C Teratogenic effects Triamcinolone acetonide has been shown to induce teratogenic effects in several species. In mice and rabbits, triamcinolone acetonide induced an increased incidence of cleft palate at dosages of approximately 120 mcg/kg/day and 24 mcg/kg/day, respectively (approximately 12 times and 10 times the amount in a typical daily human dose of triamcinolone acetonide dental paste when compared following normalization of the data on the basis of body surface area estimates, respectively).

In monkeys, triamcinolone acetonide induced cranial skeletal malformations at the lowest dosage studied (500 mcg/kg/day),which was approximately 200 times the amount in a typical daily human dose of triamcinolone acetonide dental paste when compared following normalization of the data on the basis of body surface area estimates. There are no adequate and well-controlled studies in pregnant women. However, a retrospective analysis of birth defects among children born to mothers that used drugs of the same class as triamcinolone acetonide dental paste (corticosteroids) during pregnancy found an approximately 3 times increased incidence of cleft palate.

Triamcinolone acetonide dental paste should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 76 words

Pediatric Use The safety and efficacy of triamcinolone acetonide dental paste in children is unknown. 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. Administration of corticosteroid-containing dental pastes 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.

🧓 Geriatric Use 45 words

Geriatric Use Clinical studies of triamcinolone acetonide dental paste did not include sufficient numbers of subjects age 65 and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🧬 Clinical Pharmacology 176 words

CLINICAL PHARMACOLOGY Like other topical corticosteroids, triamcinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins.

It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . Pharmacokinetics The extent of absorption through the oral mucosa is determined by multiple factors including the vehicle, the integrity of the mucosal barrier, the duration of therapy, and the presence of inflammation and/or other disease processes.

Once absorbed through the mucous membranes, the disposition of corticosteroids is similar to that of systemically administered corticosteroids. Corticosteroids are bound to the plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys; some corticosteroids and their metabolites are also excreted into the bile.

📦 How Supplied / Storage and Handling 47 words

HOW SUPPLIED Triamcinolone Acetonide Dental Paste, USP 0.1% is supplied in tubes containing 5 g of dental paste (NDC 0713-0655-40 ). Storage Keep tightly closed. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Iss. 02/2021 8-0655CPLNC1 VC7479

📦 Storage and Handling 26 words

Storage Keep tightly closed. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Iss. 02/2021 8-0655CPLNC1 VC7479

📋 Description 87 words

DESCRIPTION Triamcinolone Acetonide Dental Paste, USP 0.1%, contains the corticosteroid triamcinolone acetonide in an adhesive vehicle suitable for application to oral tissues. 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 of triamcinolone acetonide is as follows: Each gram of triamcinolone acetonide dental paste contains 1 mg triamcinolone acetonide in an emollient dental paste containing gelatin, pectin, and carboxymethylcellulose sodium in a plasticized hydrocarbon gel (a polyethylene and mineral oil gel base).

Triamcinolone Acetonide Dental Paste-1

💬 Information for Patients 95 words

Information for the Patient Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician or dentist. It is for oral use only; it is not intended for ophthalmic or dermatological use. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

Patients should report any signs of adverse reactions. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician or dentist.

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.