HomeNDC LookupIngredientsDesonide › 24470-0920-60
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DESONIDE .5 mg/g Gel

by Cintex Services, LLC · 1 TUBE in 1 CARTON (24470-920-60) / 60 g in 1 TUBE
NDC 24470-0920-60
🏷️ FDA NDC (as labeled) 24470-920-60 billing pads the product 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 →

🆔 Identity & classification

FDA NDC (as labeled) 24470-920-60
Product NDC 24470-920
11-digit billing NDC 24470092060
NCPDP billing unit GM — per gram (weight)
RxCUI 669081
UNII J280872D1O
Application # ANDA202470
SPL Set ID a6192416-09b4-47fa-e053-2a95a90add96
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 2020-07-09
Route TOPICAL
Dosage form GEL
Substance DESONIDE
GPI-14 90550035004020
GPI class Desonide
GCN Seq No 062148
GCN 97930
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% GEL
FDB brand name Desonide
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 24470-920-60 — 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 → 24470-0920-60. 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

LabelerCintex Services, LLC
Application holderSENORES PHARMACEUTICALS INC
FDA applicationANDA202470 (ANDA)
Labeler code24470
First marketedJul 2020
Product typeHuman Prescription Drug
Portfolio32 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% GEL Ingredient Desonide
📗 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.

🧪 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 HHT01ZNK31
    Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life 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 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

8 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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $6.23 $373.59 / 60 g
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
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 62332-0632-15 Alembic 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 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
Desonide .5 mg/g 72603-0164-01 NORTHSTAR 1 tube $0.410 AB Availability likely
Desonide .5 mg/g 51672-1281-01 Sun 1 tube $0.410 AB Availability likely
Desonide .5 mg/g 62332-0485-15 Alembic 1 tube $0.410 AB Availability likely
Desonide .5 mg/gthis 24470-0920-60 Cintex 1 tube FDA listed
Desonide .5 mg/g 46708-0485-15 Alembic 1 tube AB FDA listed
Desonide .5 mg/g 63187-0747-15 Proficient 1 tube AB FDA listed
Desonide .5 mg/g 70771-1381-01 Zydus 1 tube AB FDA listed
Desonide .5 mg/g 63629-2506-01 Bryant 1 tube AB FDA listed
Desonide .5 mg/g 80425-0418-01 Advanced 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 63629-2507-01 Bryant 1 tube AB FDA listed
Desonide .5 mg/g 46708-0632-15 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
Jul 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.

📊 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 Marketing startStatus
24470-0920-60 You're viewing this 1 TUBE in 1 CARTON (24470-920-60) / 60 g in 1 TUBE 2020-07-09 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 24470-920-60, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 24470-0920-60, written without dashes as 24470092060. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 24470-0920-60, the first segment (24470) is the labeler code FDA assigned to Cintex Services, LLC; the middle segment (0920) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Cintex Services, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cintex Services, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 111 words

1 INDICATIONS AND USAGE Desonide Gel, 0.05% is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Patients should be instructed to use Desonide Gel, 0.05% for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonide Gel, 0.05% to suppress the hypothalamicpituitary-adrenal (HPA) axis [see Warnings and Precautions ( 5.1 )]. Treatment should not exceed 4 consecutive weeks [see Dosage and Administration ( 2 )].

Desonide Gel, 0.05% is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. ( 1 )

⏱️ Dosage and Administration 160 words

2 DOSAGE AND ADMINISTRATION Apply a thin layer to the affected areas two times daily and rub in gently. Discontinue use when control is achieved. If no improvement is seen within 4 weeks, reassessment of diagnosis may be necessary.

Treatment beyond 4 consecutive weeks is not recommended. Do not use with occlusive dressings. Avoid contact with eyes or other mucous membranes.

For topical use only. Not for oral, ophthalmic, or intravaginal use. • Apply as a thin layer to the affected areas two times daily and rub in gently. ( 2 ) • Therapy should be discontinued when control is achieved.

( 2 ) • If no improvement is seen within 4 weeks, reassessment of diagnosis may be necessary. ( 2 ) • Should not be used with occlusive dressings. ( 2 ) • Treatment beyond 4 consecutive weeks is not recommended.

( 2 ) • For topical use only. Not for oral, ophthalmic, or intravaginal use. ( 2 )

💊 Dosage Forms and Strengths 25 words

3 DOSAGE FORMS AND STRENGTHS Gel, 0.05%; (0.5mg/g) desonide in a translucent to opaque gel Gel, 0.05%; (0.5mg/g) desonide in a translucent to opaque gel

Contraindications 34 words

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

⚠️ Warnings and Cautions ~3 min read

5 WARNINGS AND PRECAUTIONS • Topical corticosteroids can produce reversible hypothalamic pituitary adrenal (HPA) axis suppression, Cushing’s syndrome and unmask latent diabetes. ( 5.1 ) • Systemic absorption may require evaluation for HPA axis suppression. ( 5.1 ) • Modify use should HPA axis suppression develop ( 5.1 ) • Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption ( 5.1 ) • Local adverse reactions may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis and may be more likely with occlusive use or more potent corticosteroids.

( 5.2 , 5.4 , 6 ) • Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 )

5.1Effects on Endocrine System Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. The effect of Desonide Gel, 0.05% on HPA axis function was investigated in pediatric subjects, 6 months to 6 years old, with atopic dermatitis covering at least 35% of their body, who were treated with Desonide Gel, 0.05% twice daily for 4 weeks.

One of 37 subjects (3%) displayed adrenal suppression after 4 weeks of use, based on the cosyntropin stimulation test. As follow-up evaluation of the subject’s adrenal axis was not performed, it is unknown whether the suppression was reversible [see Use In Specific Populations ( 8.4 ) and Clinical Pharmacology ( 12.2 )]. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Desonide Gel, 0.05% due to their larger skin surface-to-body mass ratios [see Use In Specific Populations ( 8.4 )].

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.

If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

5.2Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include skin atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.

5.3Concomitant Skin Infections If concomitant skin infections are present or develop during treatment, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Desonide Gel, 0.05% should be discontinued until the infection is adequately controlled.

5.4Skin Irritation If irritation develops, Desonide Gel, 0.05% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis wit…

🤒 Adverse Reactions ~1 min read

6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In controlled clinical studies of 425 Desonide Gel, 0.05%-treated subjects and 157 Vehicle-treated subjects, adverse events occurred at the application site in 3% of subjects treated with Desonide Gel, 0.05% and the incidence rate was not higher compared with vehicle-treated subjects.

The most common local adverse events in Desonide Gel, 0.05% treated subjects were application site burning in 1% (4/425) and rash in 1% (3/425) followed by application site pruritus in <1% (2/425). Adverse events that resulted in premature discontinuation of study drug in Desonide Gel, 0.05% treated subjects were telangiectasia and worsening of atopic dermatitis in one subject each. Additional adverse events observed during clinical trials for patients treated with Desonide Gel, 0.05% included headache in 2% (8/425) compared with 1% (2/157) in those treated with vehicle.

The following additional local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, skin atrophy, striae, and miliaria.

The most common adverse reactions (incidence ≥ 1%) are headache and application site burning. (6) To report SUSPECTED ADVERSE REACTIONS, contact Cintex Services, LLC at 1-855-899-4237 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

👥 Use in Specific Populations ~3 min read

8 USE IN SPECIFIC POPULATIONS Safety and effectiveness of Desonide Gel, 0.05% in pediatric patients less than 3 months of age have not been evaluated, and therefore its use in this age group is not recommended. ( 8.4 ) See 17 for PATIENT COUNSELING INFORMATION. Revised: 05/2016

8.1Pregnancy Teratogenic effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, Desonide Gel, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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. No reproductive studies in animals have been performed with Desonide Gel, 0.05%. Dermal embryofetal development studies were conducted in rats and rabbits with a desonide cream, 0.05% formulation.

Topical doses of 0.2, 0.6, and 2.0 g cream/kg/day of a desonide cream, 0.05% formulation or 2.0 g/kg of the cream base were administered topically to pregnant rats (gestational days 6-15) and pregnant rabbits (gestational days 6-18). Maternal body weight loss was noted at all dose levels of the desonide cream, 0.05% formulation in rats and rabbits. Teratogenic effects characteristic of corticosteroids were noted in both species.

The desonide cream, 0.05% formulation was teratogenic in rats at topical doses of 0.6 and 2.0 g cream/kg/day and in rabbits at a topical dose of 2.0 g cream/kg/day. No teratogenic effects were noted for the desonide cream, 0.05% formulation at a topical dose of 0.2 g cream/kg/day in rats and 0.6 g cream/kg/day in rabbits. These doses (0.2 g cream/kg/day and 0.6 g cream/kg/day) are similar to the maximum recommended human dose based on body surface area comparisons.

Teratogenic effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, Desonide Gel, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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. No reproductive studies in animals have been performed with Desonide Gel, 0.05%. Dermal embryofetal development studies were conducted in rats and rabbits with a desonide cream, 0.05% formulation.

Topical doses of 0.2, 0.6, and 2.0 g cream/kg/day of a desonide cream, 0.05% formulation or 2.0 g/kg of the cream base were administered topically to pregnant rats (gestational days 6-15) and pregnant rabbits (gestational days 6-18). Maternal body weight loss was noted at all dose levels of the desonide cream, 0.05% formulation in rats and rabbits. Teratogenic effects characteristic of corticosteroids were noted in both species.

The desonide cream, 0.05% formulation was teratogenic in rats at topical doses of 0.6 and 2.0 g cream/kg/day and in rabbits at a topical dose of 2.0 g cream/kg/day. No teratogenic effects were noted for the desonide cream, 0.05% formulation at a topical dose of 0.2 g cream/kg/day in rats and 0.6 g cream/kg/day in rabbits. These doses (0.2 g cream/kg/day and 0.6 g cream/kg/day) are similar to the maximum recommended human dose based on body surface area comparisons.

8.3Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Desonide Gel, 0.05% is administered to a nursing woman.

8.4 Pediatric Use Safety and effectivene…

🆘 Overdosage 25 words

10 OVERDOSAGE Topically applied Desonide Gel, 0.05% can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions ( 5.1 )] .

🧬 Clinical Pharmacology 180 words

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of desonide is unknown.

12.2Pharmacodynamics In an HPA axis suppression study, one of 37 (3%) pediatric subjects, 6 months to 6 years old, with moderate to severe atopic dermatitis covering at least 35% body surface area who applied Desonide Gel, 0.05% experienced suppression of the adrenal glands following 4 weeks of therapy [see Warnings And Precautions ( 5.1 ) and Use In Specific Populations ( 8.4 )] . A follow-up evaluation of the subject’s adrenal axis was not performed; it is unknown whether the suppression was reversible.

12.3Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.

They are metabolized primarily in the liver and then are excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

🧬 Mechanism of Action 12 words

12.1Mechanism of Action The mechanism of action of desonide is unknown.

📦 How Supplied / Storage and Handling 49 words

16 HOW SUPPLIED/STORAGE AND HANDLING Desonide Gel, 0.05% is a translucent to opaque gel supplied in 60g tubes in cartons containing 1x 60g tube (NDC 24470-920-60). Storage: Store at controlled room temperature: 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Keep out of reach of children.

📋 Description 95 words

11 DESCRIPTION Desonide Gel, 0.05% contains desonide [(pregna-1, 4-diene-3, 20-dione,11, 21-dihydroxy-16,17-[(1-methylethylidene) bis(oxy)]-,(11β,16α)]- a synthetic nonfluorinated corticosteroid for topical dermatologic use. Chemically, desonide is C 24 H 32 O 6 . It has the following structural formula: Desonide has the molecular weight of 416.52.

It is a white to off-white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of Desonide Gel, 0.05% contains 0.5 mg of desonide in an aqueous gel base of purified water, glycerin, propylene glycol, edetate disodium, methylparaben, propylparaben, sodium hydroxide, and Carbopol ® 974 P. structure

💬 Information for Patients 196 words

17 PATIENT COUNSELING INFORMATION 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. Unless directed by the physician, the treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive. Unless directed by a physician, this medication should not be used on the underarm or groin areas of pediatric patients.

Parents of pediatric patients should be advised not to use Desonide Gel, 0.05% in the treatment of diaper dermatitis. Desonide Gel, 0.05% should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressing [see Dosage and Administration ( 2 )] . Patients should report to their physician any signs of local adverse reactions.

Other corticosteroid-containing products should not be used with Desonide Gel, 0.05% without first consulting with the physician. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.

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.