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Fluocinolone Acetonide .11 mg/mL Oil, 1 bottle — NDC 72162-2319-02 package photo

Fluocinolone Acetonide .11 mg/mL Oil, 1 bottle

by Bryant Ranch Prepack · 1 BOTTLE in 1 CARTON (72162-2319-2) / 118.28 mL in 1 BOTTLE
NDC 72162-2319-02
🏷️ FDA NDC (as labeled) 72162-2319-2 billing pads the package 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 →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Fluocinolone Acetonide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Dec 30, 2025 — Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0256-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 72162-2319-2
Product NDC 72162-2319
11-digit billing NDC 72162231902
NCPDP billing unit ML — per mL (volume)
RxCUI 1191307
UNII 0CD5FD6S2M
Application # ANDA212760
SPL Set ID 8ca4528d-7afa-451e-97ae-9c1c21c07a6e
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 2021-04-02
Route TOPICAL
Dosage form OIL
Substance FLUOCINOLONE ACETONIDE
GCN Seq No 007507
GCN 85080
HICL code 002896
Ingredient (HICL) Fluocinolone Acetonide
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 52:08.08.00
AHFS class Corticosteroids (Eent)
FDB label name FLUOCINOLONE 0.01% BODY OIL
FDB brand name Fluocinolone Acetonide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 72162-2319-2 — 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 → 72162-2319-02. 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), 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

LabelerBryant Ranch Prepack
Application holderQUAGEN PHARMACEUTICALS LLC
FDA applicationANDA212760 (ANDA)
Labeler code72162
First marketedApr 2021
Product typeHuman Prescription Drug
Portfolio4,434 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 FLUOCINOLONE 0.01% BODY OIL Ingredient Fluocinolone Acetonide
📖 What it is MedlinePlus · NLM

Fluocinolone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Fluocinolone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the form you have. The topical oil, cream, and ointment forms treat skin inflammation — especially eczema (atopic dermatitis) — and other itchy or inflamed skin condi...
  • What is fluocinolone acetonide actually used for?
  • Tilt your head so the affected ear is pointing up, then gently pull your earlobe back and upward. Apply 5 drops and stay in that position for about a minute — this lets the oil wor...
  • Yes — don't apply it to your face, armpits, or groin unless your doctor specifically tells you to. Also avoid the diaper area in babies. These are sensitive spots where steroid abs...
📖 Read our full Fluocinolone guide →

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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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
Fluocinolone acetonide .01 mg/100mL 45802-0485-26 Padagis 1 bottle $0.168 AT Availability likely —
Fluocinolone Acetonide .11 mg/118.28mL 51672-1357-08 Sun 1 bottle $0.168 AT Availability likely —
FLUOCINOLONE ACETONIDE Oil .11 mg/mL 64980-0330-04 RISING 118.28 ml $0.168 AT Availability likely —
Fluocinolone Acetonide .11 mg/mL 70752-0158-06 Quagen 1 bottle $0.168 AT Availability likely —
fluocinolone acetonide .01 mg/100mL 45802-0887-26 Padagis 1 bottle $0.178 AT Availability likely —
Fluocinolone Acetonide .11 mg/118.28mL 51672-1356-08 Sun 1 bottle $0.178 AT Availability likely —
Fluocinolone Acetonide Oil .11 mg/mL 64980-0331-04 Rising 118.28 ml $0.178 AT Availability likely —
Fluocinolone Acetonide .11 mg/mL 70752-0156-06 Quagen 1 bottle $0.178 AT Availability likely —
Fluocinolone Acetonide .11 mg/118.28mL 65162-0703-86 Amneal 1 bottle $0.222 — Discontinued —
Fluocinolone Acetonide .11 mg/mL 68462-0590-89 Glenmark 1 bottle $0.222 — FDA listed —
Derma-Smoothe/Fs .11 mg/mL 68791-0102-04 Royal 1 bottle $0.242 AT Availability likely —
Derma-Smoothe/FS .11 mg/mL 68791-0101-04 Royal 1 bottle $0.242 AT Availability likely —
Fluocinolone Acetonide Oil .11 mg/mL 50090-6780-00 A-S 118.28 ml — AT FDA listed —
Fluocinolone acetonide .01 mg/100mL 50090-7958-00 A-S 1 bottle — AT FDA listed —
fluocinolone acetonide .01 mg/100mL 63629-8655-01 Bryant 1 bottle — AT FDA listed —
Fluocinolone acetonide .01 mg/100mL 63629-8656-01 Bryant 1 bottle — AT FDA listed —
Fluocinolone Acetonide .11 mg/mL 71335-2883-01 Bryant 1 bottle — AT FDA listed —
Fluocinolone Acetonide .11 mg/mL 71335-2884-01 Bryant 1 bottle — AT FDA listed —
Fluocinolone acetonide .01 mg/100mL 72162-1412-02 Bryant 1 bottle — AT FDA listed —
fluocinolone acetonide .01 mg/100mL 72162-1434-02 Bryant 1 bottle — AT FDA listed —
Fluocinolone Acetonide .11 mg/mLthis 72162-2319-02 Bryant 1 bottle — AT FDA listed —
Fluocinolone Acetonide .11 mg/mL 72162-2321-02 Bryant 1 bottle — AT FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2021
On the market since
Apr 2021
📍
2026
Currently FDA-listed
5 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 Fluocinolone Acetonide — the program that covers self-administered drugs. 8 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 Fluocinolone Acetonide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.68M
Claims incl. refills
37.9K
Beneficiaries
30.7K
Spend / beneficiary
$54.73
Spend / claim
$44.40
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 Marketing startStatus
72162-2319-02 You're viewing this 1 BOTTLE in 1 CARTON (72162-2319-2) / 118.28 mL in 1 BOTTLE 2024-05-20 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 ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
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 72162-2319-2, 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: 72162-2319-02, written without dashes as 72162231902. 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 72162-2319-02, the first segment (72162) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (2319) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bryant Ranch Prepack 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 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Fluocinolone acetonide topical oil, 0.01% is a corticosteroid indicated for the topical treatment of atopic dermatitis in adult patients ( 1.1 ) topical treatment of moderato to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks ( 1.2 ) Limitations of Use: Apply the least amount to cover affected areas. Discontinue when disease is controlled. ( 1.3 ) Do not use in the diaper area.

( 1.3 ) Do not use on the face, axillae, or groin. ( 1.3 , 6.2 , 8.4 )

1.1Adult Patients with Atopic Dermatitis Fluocinolone acetonide topical oil, 0.01% is indicated for the topical treatment of atopic dermatitis in adult patients.

1.2Pediatric Patients with Atopic Dermatitis Fluocinolone acetonide topical oil, 0.01% is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established.

1.3Limitations of Use Apply the least amount of fluocinolone acetonide topical oil, 0.01% needed to cover the affected areas. As with other corticosteroids, fluocinolone acetonide topical oil, 0.01% should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks.

Fluocinolone acetonide topical oil, 0.01% should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. Fluocinolone acetonide topical oil, 0.01% should not be used on the face, axillae, or groin unless directed by the physician. Application to intertriginous areas should be avoided due to the increased risk of local adverse reactions. [see Adverse Reactions (6) and Use in Specific Populations (8.4) ] .

⏱️ Dosage and Administration 134 words ▾

2 DOSAGE AND ADMINISTRATION Fluocinolone acetonide topical oil, 0.01% is not for oral, ophthalmic, or intravaginal use. The dosing of fluocinolone acetonide topical oil, 0.01% is different for adult and pediatric patients. Fluocinolone acetonide topical oil, 0.01% is not for oral, ophthalmic, or intravaginal use.

( 2 ) Adult patients: Apply to affected areas 3 times daily. ( 2.1 ) Pediatric patients: Moisten skin and apply to affected areas twice daily for up to 4 weeks. ( 2.2 )

2.1Adult Patients with Atopic Dermatitis Apply fluocinolone acetonide topical oil, 0.01% as a thin film to the affected areas three times daily .

2.2Pediatric Patients with Atopic Dermatitis Moisten skin and apply fluocinolone acetonide topical oil, 0.01% as a thin film to the affected areas twice daily for up to four weeks .

💊 Dosage Forms and Strengths 35 words ▾

3 DOSAGE FORMS AND STRENGTHS Fluocinolone acetonide topical oil, 0.01% (body oil) is supplied in bottles containing 4 fluid ounces. Fluocinolone acetonide topical oil, 0.01% (body oil) is supplied in bottles containing 4 fluid ounces.

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None. None.

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Topical corticosteroids can produce reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria. ( 5.1 ) Systemic absorption may require evaluation for hypothalamic-pituitary-adrenal (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 , 5.3 , 6.1 ) Children may be more susceptible to systemic toxicity from equivalent doses. ( 5.1 , 8.4 )

5.1Hypothalamic-Pituitary-Adrenal Axis Suppression Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Cushing's syndrome, hyperglycemia, and glucosuria can also be produced by systemic absorption of topical corticosteroids. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression.

The 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 withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.

Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, and use of occlusive dressings. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Children may be more susceptible to systemic toxicity from equivalent doses 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 occur with use of topical corticosteroids and may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Some local adverse reactions may be irreversible. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. [See Adverse Reactions (6.1) ]

5.3Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

5.4Concomitant Skin Infections Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists unchanged, fluocinolone acetonide topical oil, 0.01% should be discontinued until the infection has been adequately treated.

5.5Use in Peanut-Sensitive Individuals Physicians should use caution in prescribing fluocinolone acetonide topical oil, 0.01% for peanut-sensitive individuals. [See Description (11) ] Should signs of hypersensitivity present (wheal and flare reactions, pruritus, or other manifestations), or should disease exacerbations occur, fluocinolone acetonide topical oil, 0.01% should be discontinued immediately and appropriate therapy instituted.

🤒 Adverse Reactions ~2 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. The most common adverse reactions (≥5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Quagen Pharmaceuticals LLC at 1-888-344-9603 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

( 6 )

6.1Clinical Studies Experience: Evaluation of Facial Use in Pediatric Subjects An open-label study was conducted in 58 children with moderate to severe atopic dermatitis (2 to 12 years old) to evaluate the safety of fluocinolone acetonide topical oil, 0.01% when applied to the face twice daily for 4 weeks. The following adverse reactions were reported: Incidence of Adverse Reactions (%), N=58 * The number of the individual adverse reactions reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse reaction. + End of Treatment ‡ Four Weeks Post Treatment Adverse Reaction (AR) * # of subjects (%) Day 14 Da y 28 + D a y 56 ‡ Any AE 15 (26) 6 (10) 7 (12) 7 (12) Telangiectasia 5 (9) 3 (5) 4 (7) 2 (4) Erythema 3 (5) 3 (5) Itching 3 (5) 3 (5) Irritation 3 (5) 3 (5) Burning 3 (5) 3 (5) Hypopigmentation 2 (4) 2 (4) Shiny skin 1 (2) 1 (2) Secondary atopic dermatitis 1 (2) 1 (2) Papules and pustules 1 (2) 1 (2) Keratosis pilaris 1 (2) 1 (2) Folliculitis 1 (2) 1 (2) Facial herpes simplex 1 (2) 1 (2) Acneiform eruption 1 (2) 1 (2) Ear infection 1 (2) 1 (2)

6.2Clinical Studies Experience: Evaluation in Pediatric Subjects 3 months to 2 years old An open-label safety study was conducted in 29 children to assess the HPA axis by ACTH stimulation testing following use of fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. The following adverse reactions were reported in the study [ See Use in Specific Populations (8.4) ]: Adverse Reactions (%), N=30 * * Includes one subject who withdrew at Week 2 Adverse Reactions # of subjects (%) Diarrhea 1 (3) Vomiting 1 (3) Pyrexia 3 (10) Abscess 1 (3) Molluscum 1 (3) Nasopharyngitis 2 (7) URI 1 (3) Otitis media 1 (3) Cough 6 (20) Rhinorrhea 4 (13) Atopic dermatitis 1 (3) Eczema 1 (3) Hyperpigmentation 1 (3) Hypopigmentation 2 (7) Rash 1 (3)

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from fluocinolone acetonide topical oil, 0.01%.

Therefore, fluocinolone acetonide topical oil, 0.01% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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 fluocinolone acetonide topical oil, 0.01% is administered to a nursing woman.

8.4Pediatric Use 8.4.1 Systemic Adverse Reactions in Pediatric Patients HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Because of a higher ratio of skin surface area to body mass, children are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids. [See Warnings and Precautions (5.1) ] 8.4.2 Evaluation in Peanut-Sensitive Pediatric Subjects A clinical study was conducted to assess the safety of fluocinolone acetonide topical oil, 0.01%, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 subjects with atopic dermatitis, 6 to 17 years of age.

Of the 13 subjects, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The study evaluated the subjects responses to both prick test and patch test utilizing peanut oil NF, fluocinolone acetonide topical oil, 0.01% and histamine/saline controls. Subjects were also treated with fluocinolone acetonide topical oil, 0.01% twice daily for 7 days.

Prick test and patch test results for all 13 patients were negative to fluocinolone acetonide topical oil, 0.01% and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of fluocinolone acetonide topical oil, 0.01% use. The bulk peanut oil NF, used in fluocinolone acetonide topical oil, 0.01% is heated at 475°F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins. [See Description (11) ] 8.4.3 Evaluation in Pediatric Subjects 2 to 6 years old Open-label safety studies were conducted on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis.

Subjects were treated with fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. Baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. Morning pre- stimulation cortisol and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment.

At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 µg/dL; normal: cortisol > 7µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL). 8.4.4 Evaluation in Pediatric Subjects 3 months to 2 years old An open-label safety study was conducted in 29 childr…

🤰 Pregnancy 79 words ▾

8.1Pregnancy Pregnancy Category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from fluocinolone acetonide topical oil, 0.01%.

Therefore, fluocinolone acetonide topical oil, 0.01% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use 8.4.1 Systemic Adverse Reactions in Pediatric Patients HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Because of a higher ratio of skin surface area to body mass, children are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids. [See Warnings and Precautions (5.1) ] 8.4.2 Evaluation in Peanut-Sensitive Pediatric Subjects A clinical study was conducted to assess the safety of fluocinolone acetonide topical oil, 0.01%, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 subjects with atopic dermatitis, 6 to 17 years of age.

Of the 13 subjects, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The study evaluated the subjects responses to both prick test and patch test utilizing peanut oil NF, fluocinolone acetonide topical oil, 0.01% and histamine/saline controls. Subjects were also treated with fluocinolone acetonide topical oil, 0.01% twice daily for 7 days.

Prick test and patch test results for all 13 patients were negative to fluocinolone acetonide topical oil, 0.01% and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of fluocinolone acetonide topical oil, 0.01% use. The bulk peanut oil NF, used in fluocinolone acetonide topical oil, 0.01% is heated at 475°F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins. [See Description (11) ] 8.4.3 Evaluation in Pediatric Subjects 2 to 6 years old Open-label safety studies were conducted on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis.

Subjects were treated with fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. Baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. Morning pre- stimulation cortisol and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment.

At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 µg/dL; normal: cortisol > 7µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL). 8.4.4 Evaluation in Pediatric Subjects 3 months to 2 years old An open-label safety study was conducted in 29 children (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months and 15 subjects ages > 12 months to 2 years of age) to assess the HPA axis by ACTH stimulation testing following use of fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks.

All subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area. Baseline body surface area involvement was 50% to 75% in 11 subjects and greater than 75% in 7 subjects. Morning pre-stimulation and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment.

All subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 µg/dL).

🆘 Overdosage 34 words ▾

10 OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects, including under conditions of normal use. [See Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] .

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins.

It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

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

The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

Fluocinolone acetonide topical oil, 0.01% is in the low to medium range of potency as compared with other topical corticosteroids in vasoconstrictor studies.

🧬 Mechanism of Action 86 words ▾

12.1Mechanism of Action Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins.

It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

📦 How Supplied / Storage and Handling 58 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Fluocinolone acetonide topical oil, 0.01% (body oil) is supplied in bottles containing 4 fluid ounces. It is labeled as fluocinolone acetonide topical oil, 0.01% (body oil) (NDC # 72162-2319-02). Storage: Store at 25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 181 words ▾

11 DESCRIPTION Fluocinolone acetonide topical oil, 0.01% (body oil) contains fluocinolone acetonide [(6α, 11β, 16α)-6, 9-difluoro-11, 21-dihydroxy-16, 17 [(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as fluocinolone acetonide topical oil, 0.01% (scalp oil) for use with shower caps for treatment of scalp psoriasis in adults, and as fluocinolone acetonide oil, 0.01% (ear drops) for treatment of chronic eczematous external otitis.

Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.

Each gram of fluocinolone acetonide topical oil, 0.01% (body oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Fluocinolone acetonide topical oil, 0.01% (body oil) is formulated with 48% refined peanut oil NF.

💬 Information for Patients 183 words ▾

17 PATIENT COUNSELING INFORMATION

17.1Instructions Fluocinolone acetonide topical oil, 0.01% should be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

In case of contact, wash eyes liberally with water. Fluocinolone acetonide topical oil, 0.01% should not be used for any disorder other than that for which it was prescribed. Patients should report any worsening of their skin condition to their physician promptly.

Fluocinolone acetonide topical oil, 0.01% should not be applied under occlusion unless directed by the physician. Fluocinolone acetonide topical oil, 0.01% should not be applied to the diaper area as diapers or plastic pants may constitute occlusive use. Fluocinolone acetonide topical oil, 0.01% should not be used on the face, axillae, or groin unless directed by the physician.

As with other corticosteroids, therapy should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks. Do not use other corticosteroid-containing products while using fluocinolone acetonide topical oil, 0.01% without first consulting your physician.

Manufactured for: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52025

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72162-2318-02 · Bryant 72162-2320-02 · Bryant →
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.