HomeNDC LookupIngredientsFluocinonide › 51672-1353-04
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Fluocinonide 1 mg/g Cream

by Sun Pharmaceutical Industries, Inc. · 1 TUBE in 1 CARTON (51672-1353-4) / 120 g in 1 TUBE
NDC 51672-1353-04
🏷️ FDA NDC (as labeled) 51672-1353-4 billing pads the package segment with a zero
This package
Contains120 g in 1 tube Cost per g$0.2543 NADAC Per package$30.52 / 120 g Pack sizes3 compare ↓
Also priced by: Part D plans $0.3250/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Fluocinonide (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 25, 2026 — Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0476-2026
Class II · Mar 25, 2026 — Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0477-2026
Class II · Mar 25, 2026 — Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0475-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 51672-1353-4
Product NDC 51672-1353
11-digit billing NDC 51672135304
NCPDP billing unit GM — per gram (weight)
RxCUI 485647
UNII 2W4A77YPAN
Application # ANDA200734
SPL Set ID 16c7d142-e695-4e33-986f-78cb37f7b387
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 2014-07-14
Route TOPICAL
Dosage form CREAM
Substance FLUOCINONIDE
GPI-14 90550060003710
GPI class Fluocinonide
GCN Seq No 058794
GCN 24306
HICL code 003318
Ingredient (HICL) Fluocinonide
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 FLUOCINONIDE 0.1% CREAM
FDB brand name Fluocinonide
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 51672-1353-4 — a 5-4-1 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 package segment → 51672-1353-04. 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, Corticosteroids, potent (group III)
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

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA200734 (ANDA)
Labeler code51672
First marketedJul 2014
Product typeHuman Prescription Drug
Portfolio889 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 FLUOCINONIDE 0.1% CREAM Ingredient Fluocinonide
📗 Our plain-language guide HelloPharmacist
  • Fluocinonide is used to calm inflamed, itchy skin — things like eczema (atopic dermatitis), psoriasis, and other inflammatory skin conditions that respond to steroid treatment. It...
  • What skin problems does fluocinonide actually treat?
  • Use a thin layer — just enough to cover the affected area — and rub it in gently. How often you apply it depends on your product and condition: some people use it once a day, other...
  • That's a really common feeling with skin conditions, but with the 0.1% strength products, treatment beyond 2 consecutive weeks is generally not recommended because of the risk of t...
📖 Read our full Fluocinonide guide →
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 $0.254 $30.52 / 120 g
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 $0.3250 $39.00 / 120 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2025 Jan 2026 Feb 2026 Mar 2026 $0.254 $0.216
▲ Up 18% over the last 4 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
Fluocinonide 1 mg/g 72578-0087-02 Viona 60 g $0.206 AB Availability likely save 19%
Fluocinonide 1 mg/gthis 51672-1353-04 Sun 1 tube $0.254 AB Availability likely
Fluocinonide 1 mg/g 68462-0505-35 Glenmark 30 g $0.259 FDA listed +2%
Fluocinonide 1 mg/g 63629-2508-01 Bryant 120 g AB FDA listed
Fluocinonide 1 mg/g 63629-2509-01 Bryant 60 g AB FDA listed
Fluocinonide 1 mg/g 63629-2510-01 Bryant 30 g AB FDA listed
Fluocinonide 1 mg/g 70771-1393-02 Zydus 30 g AB FDA listed
Fluocinonide 1 mg/g 72162-2006-02 Bryant 120 g AB FDA listed
Fluocinonide 1 mg/g 76420-0509-12 Asclemed 1 tube AB FDA listed
Fluocinonide 1 mg/g 76420-0530-06 Asclemed 1 tube FDA listed
Vanos 1 mg/g 99207-0525-10 Bausch 1 tube AB Discontinued
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

🏛️
2014
On the market since
Jul 2014
📍
2026
Currently FDA-listed
12 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 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 tube51672-1353-03 331 Rx · $7,565
1 tube51672-1353-02 133 Rx · $2,392
Drug total (last 4 qtrs): 464 Rx · 26,640 units · $9,958 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 Fluocinonide — the program that covers self-administered drugs. 13 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 Fluocinonide. 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
$6.96M
Claims incl. refills
176.2K
Beneficiaries
135.8K
Spend / beneficiary
$51.22
Spend / claim
$39.49
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
51672-1353-02 1 TUBE in 1 CARTON (51672-1353-2) / 30 g in 1 TUBE $0.3454 / g $10.36 2014-07-14 Active
51672-1353-03 1 TUBE in 1 CARTON (51672-1353-3) / 60 g in 1 TUBE $0.2056 / g $12.33 2014-07-14 Active
51672-1353-04 You're viewing this 1 TUBE in 1 CARTON (51672-1353-4) / 120 g in 1 TUBE $0.2543 / g $30.52 2014-07-14 Active

Per g, this pack runs about 24% above the cheapest pack (NDC 51672-1353-03, $0.2056 vs $0.2543 NADAC).

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 51672-1353-04?
NDC 51672-1353-04 is listed by the FDA — 1 tube in 1 carton / 120 g in 1 tube.
What NDC number is used to bill for this package of Fluocinonide 1 mg/g Cream?
Bill NDC 51672-1353-04 — the 11-digit billing format is 51672135304. 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.
🚨 Boxed Warning 27 words

Important: For skin use only. Do not get Fluocinonide Cream USP, 0.1% in your eyes, mouth, or vagina. Not for use on the face, groin, or underarms.

🎯 Indications and Usage ~1 min read

1 INDICATIONS AND USAGE Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. ( 1 ) Limitation of Use: Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. ( 1 ) Avoid use on the face, groin, or axillae.

( 1.2 ) Avoid use in perioral dermatitis or rosacea.

1.1Indication Fluocinonide cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [ see Use in Specific Populations (8.4) ].

1.2Limitation of Use Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of fluocinonide cream USP, 0.1% for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Do not use more than half of the 120 g tube per week. Fluocinonide cream USP, 0.1% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.

⏱️ Dosage and Administration ~1 min read

2 DOSAGE AND ADMINISTRATION For topical use only. Fluocinonide cream USP, 0.1% is not for ophthalmic, oral, or intravaginal use. For psoriasis, apply a thin layer of fluocinonide cream USP, 0.1% once or twice daily to the affected skin areas as directed by a physician.

Twice daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment. For atopic dermatitis, apply a thin layer of fluocinonide cream USP, 0.1% once daily to the affected skin areas as directed by a physician. Once daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [ see Clinical Studies (14) ] .

For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of fluocinonide cream USP, 0.1% once or twice daily to the affected areas as directed by a physician. For topical use only. Fluocinonide cream USP, 0.1% is not for ophthalmic, oral, or intravaginal use.

( 2 ) Psoriasis: apply a thin layer once or twice daily to the affected skin areas. ( 2 ) Atopic Dermatitis: apply a thin layer once daily to the affected skin areas. ( 2 ) Corticosteroid Responsive Dermatoses, other than psoriasis or atopic dermatitis: apply a thin layer once or twice daily to the affected areas.

( 2 )

💊 Dosage Forms and Strengths 31 words

3 DOSAGE FORMS AND STRENGTHS Cream, 0.l%. Each gram of fluocinonide cream USP, 0.1% contains 1 mg of fluocinonide in a white to off-white cream base. Cream, 0.1% ( 3 )

Contraindications 7 words

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~3 min read

5 WARNINGS AND PRECAUTIONS Fluocinonide cream USP, 0.1% has been shown to suppress the HPA axis. Systemic absorption of fluocinonide cream USP, 0.1% may produce reversible hypothalamic-pituitaryadrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia 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 ( 5.3 ) Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation and allergic contact dermatitis and may be more likely to occur with occlusive use or more potent corticosteroids ( 5.3 ) Children may be more susceptible to systemic toxicity when treated with topical corticosteroids.

( 5.1 , 8.4 )

5.1Effect on Endocrine System Systemic absorption of topical corticosteroids, including fluocinonide cream USP, 0.1%, 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. In addition, the use of fluocinonide cream USP, 0.1% for longer than 2 weeks may suppress the immune system [ see Nonclinical Toxicology (13.1) ].

HPA axis suppression has been observed with fluocinonide cream USP, 0.1% applied once or twice daily in 2 out of 18 adult patients with plaque-type psoriasis, 1 out of 31 adult patients with atopic dermatitis and 4 out of 123 pediatric patients with atopic dermatitis [ see Use in Specific Population (8.4) and Clinical Pharmacology (12.2) ]. Because of the potential for systemic absorption, use of topical corticosteroids, including fluocinonide cream USP, 0.1%, 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 absorption of topical corticosteroids. Studies conducted in pediatric patients demonstrated reversible HPA axis suppression after use of fluocinonide cream USP, 0.1%. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of fluocinonide cream USP, 0.1% due to their larger skin surface-to-body-mass ratios [ See Use in Specific Populations (8.4) ].

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 atrophy, striae, telangiectasis, 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, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use…

🤒 Adverse Reactions ~1 min read

6 ADVERSE REACTIONS The most commonly reported adverse reactions (≥1%) were headache, application site burning, nasopharyngitis, and nasal congestion. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In clinical trials, a total of 443 adult subjects with atopic dermatitis or plaque-type psoriasis were treated once daily or twice daily with fluocinonide cream USP, 0.1% for 2 weeks. The most commonly observed adverse reactions in these clinical trials were as follows: Table 1: Most Commonly Observed Adverse Reactions (≥1%) in Adult Clinical Trials Adverse Reaction Fluocinonide Cream USP, 0.1%, once daily (n=216) Fluocinonide Cream USP, 0.1%, twice daily (n=227) Vehicle Cream, once or twice daily (n=211) Headache 8 (3.7%) 9 (4.0%) 6 (2.8%) Application Site Burning 5 (2.3%) 4 (1.8%) 14 (6.6%) Nasopharyngitis 2 (0.9%) 3 (1.3%) 3 (1.4%) Nasal Congestion 3 (1.4%) 1 (0.4%) 0 Safety in patients 12 to 17 years of age was similar to that observed in adults.

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of fluocinonide cream USP, 0.1%: Administration Site Conditions: discoloration, erythema, irritation, pruritus, swelling, pain and condition aggravated. Immune System Disorders: hypersensitivity. Nervous System Disorders: headache and dizziness.

Skin and Subcutaneous Tissue Disorders: acne, dry skin, rash, skin exfoliation and skin tightness. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

👥 Use in Specific Populations ~3 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Therefore, fluocinonide cream USP, 0.1% 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.

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 breast milk. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use Safety and efficacy of fluocinonide cream USP, 0.1% in pediatric patients younger than 12 years of age have not been established; therefore use in pediatric patients younger than 12 years of age is not recommended. HPA axis suppression was studied in 4 sequential cohorts of pediatric patients with atopic dermatitis covering at least 20% of the body surface area, treated once daily or twice daily with fluocinonide cream USP, 0.1%. The first cohort of 31 patients (mean 36.3% BSA) 12 to < 18 years old; the second cohort included 31 patients (mean 39.0% BSA) 6 to < 12 years old; the third cohort included 30 patients (mean 34.6% BSA) 2 to < 6 years old; the fourth cohort included 31 patients (mean 40.0% BSA) 3 months to < 2 years old.

Fluocinonide cream USP, 0.1% caused HPA-axis suppression in 1 patient in the twice daily group in Cohort 1, 2 patients in the twice daily group in Cohort 2, and 1 patient in the twice daily group in Cohort 3. Follow-up testing 14 days after treatment discontinuation, available for all 4 suppressed patients, demonstrated a normally responsive HPA axis. Signs of skin atrophy were present at baseline and severity was not determined making it difficult to assess local skin safety.

Therefore, the safety of fluocinonide cream USP, 0.1% in patients younger than 12 years of age has not been demonstrated [ see Warnings and Precautions (5.2) ]. HPA axis suppression has not been evaluated in patients with psoriasis who are less than 18 years of age. 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 cosyntropin (ACTH 1-24 ) stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

8.5Geriatric Use Clinical studies of fluocinonide cream USP, 0.1% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🤰 Pregnancy 71 words

8.1Pregnancy Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Therefore, fluocinonide cream USP, 0.1% 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.

🧒 Pediatric Use ~2 min read

8.4Pediatric Use Safety and efficacy of fluocinonide cream USP, 0.1% in pediatric patients younger than 12 years of age have not been established; therefore use in pediatric patients younger than 12 years of age is not recommended. HPA axis suppression was studied in 4 sequential cohorts of pediatric patients with atopic dermatitis covering at least 20% of the body surface area, treated once daily or twice daily with fluocinonide cream USP, 0.1%. The first cohort of 31 patients (mean 36.3% BSA) 12 to < 18 years old; the second cohort included 31 patients (mean 39.0% BSA) 6 to < 12 years old; the third cohort included 30 patients (mean 34.6% BSA) 2 to < 6 years old; the fourth cohort included 31 patients (mean 40.0% BSA) 3 months to < 2 years old.

Fluocinonide cream USP, 0.1% caused HPA-axis suppression in 1 patient in the twice daily group in Cohort 1, 2 patients in the twice daily group in Cohort 2, and 1 patient in the twice daily group in Cohort 3. Follow-up testing 14 days after treatment discontinuation, available for all 4 suppressed patients, demonstrated a normally responsive HPA axis. Signs of skin atrophy were present at baseline and severity was not determined making it difficult to assess local skin safety.

Therefore, the safety of fluocinonide cream USP, 0.1% in patients younger than 12 years of age has not been demonstrated [ see Warnings and Precautions (5.2) ]. HPA axis suppression has not been evaluated in patients with psoriasis who are less than 18 years of age. 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 cosyntropin (ACTH 1-24 ) stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

🧓 Geriatric Use 30 words

8.5Geriatric Use Clinical studies of fluocinonide cream USP, 0.1% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🆘 Overdosage 25 words

10 OVERDOSAGE Topically applied fluocinonide cream USP, 0.1% can be absorbed in sufficient amounts to produce systemic effects [ see Warnings and Precautions (5.1) ].

🧬 Clinical Pharmacology ~1 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of fluocinonide cream USP, 0.1% in corticosteroid responsive dermatoses is unknown.

12.2Pharmacodynamics Vasoconstrictor studies performed with fluocinonide cream USP, 0.1% in healthy subjects indicate that it is in the super-high range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence. Application of fluocinonide cream USP, 0.1% twice daily for 14 days in 18 adult subjects with plaque-type psoriasis (10–50% BSA, mean 19.6% BSA) and 31 adult subjects (17 treated once daily; 14 treated twice daily) with atopic dermatitis (2-10% BSA, mean 5% BSA) showed demonstrable HPA-axis suppression in 2 subjects with psoriasis (with 12% and 25% BSA) and 1 subject with atopic dermatitis (treated once daily, 4% BSA) where the criterion for HPA-axis suppression is a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (ACTH 1-24 ) [ see Warnings and Precautions (5.1) ].

HPA-axis suppression following application of fluocinonide cream USP, 0.1% (once or twice daily) was also evaluated in 123 pediatric patients from 3 months to < 18 years of age with atopic dermatitis (mean BSA range 34.6 % - 40.0 %). HPA-axis suppression was observed in 4 patients in the twice daily groups. Follow-up testing 14 days after treatment discontinuation demonstrated a normally responsive HPA axis in all 4 suppressed patients [see Warnings and Precautions (5.1) and Use in Specific populations (8.4) ] .

12.3Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

🧬 Mechanism of Action 34 words

12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of fluocinonide cream USP, 0.1% in corticosteroid responsive dermatoses is unknown.

📦 How Supplied / Storage and Handling 52 words

16 HOW SUPPLIED/STORAGE AND HANDLING Fluocinonide cream USP, 0.1% is white to off-white in color and is supplied in tubes as follows: 30 g (NDC 51672-1353-2) 60 g (NDC 51672-1353-3) 120 g (NDC 51672-1353-4) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep the tube tightly closed.

📦 Storage and Handling 18 words

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep the tube tightly closed.

📋 Description 136 words

11 DESCRIPTION Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate.

Its chemical formula is C 26 H 32 F 2 O 7 and it has a molecular weight of 494.58. It has the following chemical structure: Fluocinonide, USP is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol.

Each gram of fluocinonide cream USP, 0.1% contains 1 mg micronized fluocinonide in a cream base of carbomer 940 (carbopol 980), ceteareth-20, citric acid, diethylene glycol monoethyl ether (transcutol P), polyethylene glycol, propylene glycol, sorbitan monostearate, and trolamine. Chemical Structure

💬 Information for Patients ~1 min read

17 PATIENT COUNSELING INFORMATION [See FDA-approved patient labeling (Patient Information) ] Patients using fluocinonide cream USP, 0.1% should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or unintended effects: Fluocinonide cream USP, 0.1% is to be used as directed by the physician.

It is for external use only. Avoid contact with the eyes. It should not be used on the face, groin, and underarms.

Fluocinonide cream USP, 0.1% should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged or 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.

Other corticosteroid-containing products should not be used with fluocinonide cream USP, 0.1% without first talking to the physician. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen in 2 weeks, the patient should be instructed to contact a physician.

The safety of the use of fluocinonide cream USP, 0.1% for longer than 2 weeks has not been established. Patients should be informed to not use more than 60 g per week of fluocinonide cream USP, 0.1%. Do not use more than half of the 120 g tube per week.

Patients should inform their physicians that they are using fluocinonide cream USP, 0.1% if surgery is contemplated. Patients should wash their hands after applying medication.

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.