Home › NDC Lookup › Ingredients › Fluocinonide, Dimethicone › 59088-0754-00
📦image loading
(from DailyMed)

Fluopar fluocinonide, dimethicone Kit

by PureTek Corporation · 1 KIT in 1 KIT (59088-754-00) * 1 TUBE in 1 CARTON (45802-151-94) / 30 g in 1 TUBE * 118 mL in 1 TUBE (59088-333-08)
NDC 59088-0754-00
🏷️ FDA NDC (as labeled) 59088-754-00 billing pads the product segment with a zero
Rx only 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 59088-754-00
Product NDC 59088-754
11-digit billing NDC 59088075400
NCPDP billing unit EA — each (per item)
RxCUI 259090, 485647
SPL Set ID 9ff7fa78-0fca-976f-e053-2995a90a4641
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-01-14
Dosage form KIT
GPI-14 90559902416420
GPI class Fluopar
GCN Seq No 081202
GCN 48246
HICL code 046632
Ingredient (HICL) Fluocinonide/Dimethicone
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 FLUOPAR 0.1%-5% CREAM KIT
FDB brand name Fluopar
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 59088-754-00 — 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 → 59088-0754-00. 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 Other ectoparasiticides, incl. scabicides class.

Drug family (ATC) Other ectoparasiticides, incl. scabicides
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

LabelerPureTek Corporation
Labeler code59088
First marketedJan 2014
Product typeHuman Prescription Drug
Portfolio176 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 FLUOPAR 0.1%-5% CREAM KIT Ingredient Fluocinonide/Dimethicone
🧪 What is this product?

Fluopar is a prescription kit containing fluocinonide, a topical steroid, and dimethicone, a skin protectant. Fluocinonide is typically used to reduce inflammation and itching in skin conditions, while dimethicone is commonly used as a barrier agent to protect and soothe skin. This product is marketed without an approved FDA application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

From the label’s inactive-ingredient sectionAleurites moluccana seed oil, Aloe barbadensis (Aloe vera) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, DermacinRx Complex® [consisting of: bisabolol, calcium pantothenate (vitamin B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG100 stearate, pentaerythrityl tetraditbutyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine.

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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 eachPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
Fluoparthis 59088-0754-00 PureTek 1 kit — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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
Jan 2014
📍
2026
Currently FDA-listed
12 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59088-0754-00 You're viewing this 1 KIT in 1 KIT (59088-754-00) * 1 TUBE in 1 CARTON (45802-151-94) / 30 g in 1 TUBE * 118 mL in 1 TUBE (59088-333-08) 2020-03-03 Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application Kit / multi-component package

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
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 59088-754-00, 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: 59088-0754-00, written without dashes as 59088075400. 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 59088-0754-00, the first segment (59088) is the labeler code FDA assigned to PureTek Corporation; the middle segment (0754) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 PureTek Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PureTek Corporation 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 ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions ⚠️ Warnings 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📋 Description 💬 Information for Patients 💬 Patient Medication Information
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE These highlights do not include all the information needed to use Fluocinonide Cream USP, 0.1% safely and effectively. See full prescribing information for Fluocinonide Cream USP, 0.1%. Fluocinonide Cream USP, 0.1% For topical use Initial U.S.

Approval: 1971 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Fluocinonide Cream USP, 0.1% safely and effectively. See full prescribing information for Fluocinonide Cream USP, 0.1%. Fluocinonide Cream USP, 0.1% For topical use Initial U.S.

Approval: 1971 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. 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.

Uses ■ for the treatment and/or prevention of diaper rash ■ temporarily protects and helps relieve chapped or cracked skin

⏱️ Dosage and Administration 75 words ▾

2 DOSAGE AND ADMINISTRATION For topical use only. Fluocinonide Cream USP, 0.1% is not for ophthalmic, oral, or intravaginal use. Psoriasis: apply a thin layer once or twice daily to the affected skin areas. Atopic Dermatitis: apply a thin layer once daily to the affected skin areas. Corticosteroid Responsive Dermatoses, other than psoriasis or atopic dermatitis: apply a thin layer once or twice daily to the affected areas.

Directions ■ apply cream liberally as needed

💊 Dosage Forms and Strengths 27 words ▾

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

⛔ Contraindications 3 words ▾

4 CONTRAINDICATIONS None.

⚠️ 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-pituitary-adrenal (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, 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, 0.1%. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of fluocinonide cream, 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 of Fluocinonide Cream U…

⚠️ Warnings 76 words ▾

Warnings For external use only Do not use on ■ deep or puncture wounds ■ animal bites ■ serious burns When using this product ■ do not get into eyes Stop use and ask a doctor if ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The most commonly reported adverse reactions (≥1%) were headache, application site burning, nasopharyngitis, and nasal congestion. To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 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, 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 Safety in patients 12 to 17 years of age was similar to that observed in adults.

Table 1

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of fluocinonide cream, 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 ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Teratorgenic 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, 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, 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, 0.1% in patients younger than 12 years of age has not been demonstrated [see Warnings and Precautions (5.1)]. 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 (ACTH1-24) stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

8.5Geriatric Use Clinical studies of fluocinonide cream, 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 Teratorgenic 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, 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, 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, 0.1% in patients younger than 12 years of age has not been demonstrated [see Warnings and Precautions (5.1)]. 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 (ACTH1-24) stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

🧓 Geriatric Use 29 words ▾

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

🆘 Overdosage 23 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, 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, 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 (ACTH1-24) [see Warnings and Precautions (5.1)].

HPA-axis suppression following application of fluocinonide cream, 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 40 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 45802- 151 -94) 60 g (NDC 45802- 151 -96) 120 g (NDC 45802- 151 -53)

📦 Storage and Handling 27 words ▾

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

Other information ■ protect from freezing ■ avoid excessive heat

🧪 Active Ingredient 4 words ▾

Active ingredient Dimethicone 5.0%

🧪 Inactive Ingredients 84 words ▾

Inactive ingredients Aleurites moluccana seed oil, Aloe barbadensis (Aloe vera) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, DermacinRx Complex® [consisting of: bisabolol, calcium pantothenate (vitamin B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG100 stearate, pentaerythrityl tetraditbutyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine.

🎯 Purpose 3 words ▾

Purpose Skin Protectant

📋 Description 129 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 6α, 9-Difluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione, cyclic 16, 17-acetal with acetone, 21-acetate.

Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.52. It has the following chemical structure: Fluocinonide 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 fluocinonide in a cream base of carbopol 980, citric acid, diisopropanolamine, glycerin, glyceryl monostearate, glyceryl stearate, isostearic acid, PEG-100 stearate, polyethylene glycol monomethyl ether, propylene glycol, and water. C26H32F2O7

💬 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.

Rx Only Made in Israel Manufactured By Perrigo Yeruham, Israel Distributed By Perrigo® Allegan, MI 49010 www.perrigo.com Rev 01-19 1M100 RC J5

💬 Patient Medication Information ~3 min read ▾

PATIENT INFORMATION Fluocinonide Cream USP, 0.1% 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.

Read the Patient Information that comes with Fluocinonide Cream USP, 0.1% before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your condition or treatment.

What is Fluocinonide Cream USP, 0.1%? Fluocinonide Cream USP, 0.1% is a prescription corticosteroid medicine used on the skin (topical) to treat adults and children 12 years and older with certain skin conditions that cause red, flaky, and itchy skin. • You should not use Fluocinonide Cream USP, 0.1% for longer than 2 weeks in a row. • You should not use more than 60 grams of Fluocinonide Cream USP, 0.1% or more than half of the 120 gram tube in 1 week. • Fluocinonide Cream USP, 0.1% should not be used: •if you have skin swelling or redness on the nose of face (rosacea) • for a scaly or bumpy rash around your mouth (perioral dermatitis) • on your face, underarms, or groin area It is not known if Fluocinonide Cream USP, 0.1% is safe and effective in children under 12 years of age.

What should I tell my doctor before using Fluocinonide Cream USP, 0.1%? Before using Fluocinonide Cream USP, 0.1% , tell your doctor if you: •have had irritation or other skin reaction to a steroid medicine in the past •have adrenal gland problems •plan to have surgery •are pregnant or plan to become pregnant. It is not known if Fluocinonide Cream USP, 0.1% will harm your unborn baby.

Talk to your doctor if you are pregnant or plan to become pregnant. •are breast-feeding or plan to breastfeed. It is not known if Fluocinonide Cream USP, 0.1% passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Fluocinonide Cream USP, 0.1% .

Tell your doctor about all the medicine you take including prescriptions and non-prescriptions medicines, vitamins, and herbal supplements. Especially tell your doctor if you take a corticosteroid medicine by mouth or use other products on your skin that contain corticosteroids. Ask your doctor or pharmacist if you are not sure.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine. How should I use Fluocinonide Cream USP, 0.1%? • See “What is Fluocinonide Cream USP, 0.1%?” • Use Fluocinonide Cream USP, 0.1% exactly as your doctor tells you. • This medicine is for use on the skin only.

Do not use Fluocinonide Cream USP, 0.1% in your eyes, mouth or vagina. • Wash your hands after you use Fluocinonide Cream USP, 0.1%. • Do not use Fluocinonide Cream USP, 0.1% for longer than 2 weeks in a row. • Talk to your doctor if your skin does not get better after 2 weeks of treatment with Fluocinonide Cream USP, 0.1% . • Do not bandage or cover the skin treated with Fluocinonide Cream USP, 0.1% unless your doctor tells you to. What are the possible side effects with Fluocinonide Cream USP, 0.1%? Fluocinonide Cream USP, 0.1% may cause side effects, including: • Symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment or after stopping treatment.

Your doctor may do blood tests to check you for adrenal insufficiency while you are using Fluocinonide Cream USP, 0.1% . Tell your doctor if you have any of these symptoms of adrenal insufficiency: • tiredness that worsens and does not go away • nausea or vomiting • dizziness or fainting • muscle weakness • irritability and depression • loss of appetite • weight loss • Cushing’s syndrome, when the body is exposed to too much of the hormone cortisol. Your doctor may do tests to check for this.

Symptoms can include: • weight gain, especially around your upper back and midsection • slow healing of cuts, insect bites and infections • tiredness and muscle weakness • depr…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 59088-0731-00 · PureTek 59088-0755-00 · PureTek →
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.