HomeNDC LookupIngredientsDesonide › 72578-0086-01
Desonide .5 mg/g Cream — NDC 72578-0086-01 package photo

Desonide .5 mg/g Cream

by Viona Pharmaceuticals Inc · 1 TUBE in 1 CARTON (72578-086-01) / 15 g in 1 TUBE
NDC 72578-0086-01
🏷️ FDA NDC (as labeled) 72578-086-01 billing pads the product segment with a zero
This package
Contains15 g in 1 tube Cost per g$0.3025 NADAC Per package$4.54 / 15 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.8147/unit · Part D plans $0.9824/unit — full pricing hub ↓
Also comes in: 60 g 72578-0086-02
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 →

🆔 Identity & classification

FDA NDC (as labeled) 72578-086-01
Product NDC 72578-086
11-digit billing NDC 72578008601
NCPDP billing unit GM — per gram (weight)
RxCUI 349351
UNII J280872D1O
Application # ANDA210198
SPL Set ID fdeb2a20-a612-4ae5-9178-222295271274
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 2020-06-17
Route TOPICAL
Dosage form CREAM
Substance DESONIDE
GPI-14 90550035003705
GPI class Desonide
GCN Seq No 007620
GCN 31425
HICL code 003322
Ingredient (HICL) Desonide
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 84:06.08.00
AHFS class Corticosteroids (Skin, Mucous Membrane)
FDB label name DESONIDE 0.05% CREAM
FDB brand name Desonide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 72578-086-01 — 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 → 72578-0086-01. 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, moderately potent (group II), Corticosteroids, plain
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

LabelerViona Pharmaceuticals Inc
Application holderCADILA HEALTHCARE LTD
FDA applicationANDA210198 (ANDA)
Labeler code72578
First marketedJun 2020
Product typeHuman Prescription Drug
Portfolio94 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 DESONIDE 0.05% CREAM Ingredient Desonide
📖 What it is MedlinePlus · NLM

Desonide is used to treat the redness, swelling, itching, 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). Desonide is in a class of medications called topical 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
  • Desonide is a mild topical steroid used to calm inflamed, itchy skin. Desonide gel is specifically approved for mild to moderate atopic dermatitis — commonly called eczema — in bab...
  • What skin problems is desonide actually used for?
  • Apply a thin layer to the affected skin only — you don't need a thick coat. The gel is typically used twice a day; the cream or ointment may be used two to four times a day dependi...
  • Desonide is meant to be used for the shortest time needed to get your skin under control. The gel form should not be used for more than 4 consecutive weeks. The cream and ointment...
📖 Read our full Desonide guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Desonide — tap one for details:

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 34S289N54E
    Aluminum sulfate is a salt compound used in medicines as an astringent and buffering agent. It helps regulate acidity and can be used in topical or oral formulations to reduce moisture and control pH levels.
  • UNII Y882YXF34X
    Calcium acetate is a mineral salt made from calcium and acetic acid. In medicines, it acts as a binder to hold ingredients together and can help control the acidity level of the formulation.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • 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 2NX48Z0A9G
    Icodextrin is a glucose polymer derived from starch. It acts as a thickening agent and osmotic agent in medicines, helping to control texture and absorption in formulations like eye drops or injectable solutions.
  • UNII N6K5787QVP
    Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 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.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

11 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 $0.303 $4.54 / 15 g
Medicaid paysCMS SDUD · 12 mo $0.8147 $12.22 / 15 g
Medicare drug plans payPart D · Q2 2026 $0.9824 $14.74 / 15 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.903 $0.256
▼ Down 63% 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
Desonide .5 mg/g 00472-0804-15 Actavis 1 tube $0.266 AB Discontinued save 12%
Desonide .5 mg/g 00713-0661-15 Cosette 1 tube $0.302 AB Availability likely
Desonide .5 mg/g 16714-0729-01 NORTHSTAR 1 tube $0.302 AB Availability likely
Desonide .5 mg/g 51672-1280-01 Sun 1 tube $0.302 AB Availability likely
Desonide .5 mg/g 62332-0632-15 Alembic 1 tube $0.302 AB Availability likely
Desonide .5 mg/gthis 72578-0086-01 Viona 1 tube $0.302 AB Availability likely
Desonide .5 mg/g 45802-0423-35 Padagis 1 tube $0.410 AB Availability likely +36%
Desonide .5 mg/g 72603-0164-01 NORTHSTAR 1 tube $0.410 AB Availability likely +36%
Desonide .5 mg/g 51672-1281-01 Sun 1 tube $0.410 AB Availability likely +36%
Desonide .5 mg/g 62332-0485-15 Alembic 1 tube $0.410 AB Availability likely +36%
Desonide .5 mg/g 46708-0632-15 Alembic 1 tube AB FDA listed
Desonide .5 mg/g 63187-0747-15 Proficient 1 tube AB FDA listed
Desonide .5 mg/g 63629-2506-01 Bryant 1 tube AB FDA listed
Desonide .5 mg/g 63629-2507-01 Bryant 1 tube AB FDA listed
Tridesilon Cream .03 g/60g 69482-0600-60 Encore 1 tube FDA listed
Desonide .5 mg/g 70771-1381-01 Zydus 1 tube AB FDA listed
Desonide .5 mg/g 72162-2005-02 Bryant 1 tube AB FDA listed
Desonide .5 mg/g 80425-0371-01 Advanced 1 tube AB FDA listed
Desonide .5 mg/g 80425-0418-01 Advanced 1 tube AB FDA listed
Desonide .5 mg/g 24470-0920-60 Cintex 1 tube FDA listed
Desonide .5 mg/g 46708-0485-15 Alembic 1 tube AB 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

🏛️
2020
On the market since
Jun 2020
📍
2026
Currently FDA-listed
6 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 72578-0086-01, 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
25.6K
Units reimbursed last 4 qtrs
640K
Gross reimbursed last 4 qtrs
$521.4K
Avg / prescription
$20.38
Avg / unit
$0.8147
Latest quarter Q4 2025
5.9KRx
Medicaid pays / g
$0.8147
gross reimbursed
vs
NADAC / g
$0.3025
acquisition cost
=
Spread
+$0.5122
+169% 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
36% FFS 64% MCO
Fee-for-service · 9,094 Rx Managed care · 16,497 Rx
State Medicaid map
Alaska: no data reported AK Maine: 3,075 units · 220 per 100k residents ME Washington: 32,535 units · 416 per 100k residents WA Idaho: 5,070 units · 258 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 26,175 units · 456 per 100k residents MN Wisconsin: no data reported WI Michigan: 2,310 units · 23.0 per 100k residents MI New York: 4,605 units · 23.5 per 100k residents NY Vermont: 540 units · 83.5 per 100k residents VT New Hampshire: 3,315 units · 236 per 100k residents NH Oregon: 3,900 units · 92.1 per 100k residents OR Nevada: 885 units · 27.7 per 100k residents NV Wyoming: 255 units · 43.7 per 100k residents WY South Dakota: 1,695 units · 184 per 100k residents SD Iowa: 1,860 units · 58.0 per 100k residents IA Illinois: 20,850 units · 166 per 100k residents IL Indiana: 10,605 units · 155 per 100k residents IN Ohio: 57,315 units · 486 per 100k residents OH Pennsylvania: 4,335 units · 33.4 per 100k residents PA New Jersey: 27,345 units · 294 per 100k residents NJ Massachusetts: 23,445 units · 335 per 100k residents MA California: 87,390 units · 224 per 100k residents CA Utah: 3,315 units · 97.0 per 100k residents UT Colorado: 24,465 units · 416 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 10,395 units · 230 per 100k residents KY West Virginia: no data reported WV Virginia: 8,460 units · 97.1 per 100k residents VA Maryland: 21,345 units · 345 per 100k residents MD Connecticut: 17,670 units · 489 per 100k residents CT Rhode Island: 2,400 units · 219 per 100k residents RI Arizona: no data reported AZ New Mexico: 3,000 units · 142 per 100k residents NM Kansas: 9,420 units · 320 per 100k residents KS Arkansas: 10,620 units · 346 per 100k residents AR Tennessee: 10,920 units · 153 per 100k residents TN North Carolina: 56,970 units · 526 per 100k residents NC South Carolina: 17,685 units · 329 per 100k residents SC Delaware: no data reported DE Oklahoma: 7,215 units · 178 per 100k residents OK Louisiana: 5,175 units · 113 per 100k residents LA Mississippi: 17,010 units · 579 per 100k residents MS Alabama: 46,605 units · 912 per 100k residents AL Georgia: 18,945 units · 172 per 100k residents GA D.C.: 5,730 units · 844 per 100k residents DC Hawaii: 12,660 units · 882 per 100k residents HI Texas: 9,330 units · 30.6 per 100k residents TX Florida: 3,195 units · 14.1 per 100k residents FL
Units reimbursed · per 100k residents
14.1912
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 Alabama 912 /100k
2 Hawaii 882 /100k
3 D.C. 844 /100k
4 Mississippi 579 /100k
5 North Carolina 526 /100k
6 Connecticut 489 /100k
7 Ohio 486 /100k
8 Minnesota 456 /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 page72578-0086-01 25,591 Rx · $521,424
1 tube72578-0086-02 25,253 Rx · $824,924
Drug total (last 4 qtrs): 50,844 Rx · 2,149,636 units · $1,346,348 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 Desonide — the program that covers self-administered drugs. 9 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 Desonide. 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
$2.45M
Claims incl. refills
55.6K
Beneficiaries
48.4K
Spend / beneficiary
$50.71
Spend / claim
$44.15
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 Desonide — the ingredient across all brands.

Top reported reactions

Macular Degeneration787
Pain392
Nausea376
Pruritus345
Rash327
Headache322
Erythema316

Reporter sex

4,959 reports
Male · 35%
Female · 64%
Unknown · 0%

Serious outcomes

Death196
Disabling91
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 620 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
72578-0086-01 You're viewing this 1 TUBE in 1 CARTON (72578-086-01) / 15 g in 1 TUBE $0.3025 / g $4.54 2020-06-17 Active
72578-0086-02 1 TUBE in 1 CARTON (72578-086-02) / 60 g in 1 TUBE $0.1996 / g $11.98 2020-06-17 Active

Per g, this pack runs about 52% above the cheapest pack (NDC 72578-0086-02, $0.1996 vs $0.3025 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 50% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 72578-0086-01?
NDC 72578-0086-01 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 Desonide .5 mg/g Cream?
Bill NDC 72578-0086-01 — the 11-digit billing format is 72578008601. 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 40 words

INDICATIONS AND USAGE Desonide cream, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.

⏱️ Dosage and Administration 65 words

DOSAGE AND ADMINISTRATION Desonide cream, 0.05% should be applied to the affected area as a thin film two to four times daily depending on the severity of the condition. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary. Desonide cream, 0.05% should not be used with occlusive dressings.

Contraindications 22 words

CONTRAINDICATIONS Desonide cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

🤒 Adverse Reactions 133 words

ADVERSE REACTIONS In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide cream, 0.05% was approximately 1%. These adverse reactions were pruritus, pain, folliculitis, rash, peripheral edema, pustular rash, sweating, erythema, irritation, and burning. Laboratory abnormalities were found in 3% of the patients.

These were hyperglycemia (2%) and liver function abnormality (1%). The following additional local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in approximate decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, burning and hypopigmentation.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

🤰 Pregnancy 103 words

Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Animal reproductive studies have not been conducted with desonide cream, 0.05%.

It is also not known whether desonide cream, 0.05% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. There are no adequate and well-controlled studies in pregnant women. Desonide cream, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 131 words

Pediatric Use Safety and effectiveness in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment.

Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

🆘 Overdosage 19 words

OVERDOSAGE Topically applied desonide cream, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

🧬 Clinical Pharmacology 179 words

CLINICAL PHARMACOLOGY Like other topical corticosteroids, desonide 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 percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier.

Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Studies performed with desonide cream, 0.05% indicate that it is in the low range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 69 words

HOW SUPPLIED Desonide cream USP, 0.05% is white to off white cream and is available as follows: NDC 72578-086-01 in tube of 15 g NDC 72578-086-02 in tube of 60 g Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.

📋 Description 150 words

DESCRIPTION Desonide cream USP, 0.05% contains desonide (Pregna-1, 4-diene-3, 20-dione, 11, 21-dihydroxy-16, 17-[(1- methylethylidene)bis(oxy)]-,(11β,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in desonide cream, 0.05% is C 24 H 32 O 6 .

It has the following structural formula: The molecular weight of desonide is 416.51. It is a white to almost white crystalline powder. It is insoluble in water, soluble in methylene chloride, sparingly soluble in ethanol (96%), slightly soluble in ethyl ether.

Each gram of desonide cream USP, 0.05% contains 0.5 milligram of desonide micro dispersed in a base of aluminum sulfate, calcium acetate, cetostearyl alcohol, dextrin, glycerin, light mineral oil, purified water, sodium lauryl sulfate, synthetic beeswax, and white petrolatum. Desonide cream, 0.05% is preserved with methylparaben and buffered to pH 4.2 to 5.0. Desonide Cream

💬 Information for Patients 87 words

Information for Patients Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

This medication should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive unless directed by the physician. Patients should report to their physician any signs of local adverse reactions.

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.