HomeNDC LookupIngredientsFluocinolone Acetonide › 64980-0330-04
FLUOCINOLONE ACETONIDE Oil .11 mg/mL Oil, 118.28 mL — NDC 64980-0330-04 package photo

FLUOCINOLONE ACETONIDE Oil .11 mg/mL Oil, 118.28 mL

by RISING PHARMA HOLDINGS, INC. · 118.28 mL in 1 BOTTLE (64980-330-04)
NDC 64980-0330-04
🏷️ FDA NDC (as labeled) 64980-330-04 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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) 64980-330-04
Product NDC 64980-330
11-digit billing NDC 64980033004
NCPDP billing unit ML — per mL (volume)
RxCUI 1191307
UNII 0CD5FD6S2M
Application # ANDA090982
SPL Set ID f4a58ecc-cd50-4414-add1-a82b09da2058
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 2016-07-18
Route TOPICAL
Dosage form OIL
Substance FLUOCINOLONE ACETONIDE
GPI-14 90550055101714
GPI class Fluocinolone Acetonide Scalp
GCN Seq No 058950
GCN 24484
HICL code 032834
Ingredient (HICL) Fluocinolone/Shower Cap
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 FLUOCINOLONE 0.01% SCALP 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 64980-330-04 — 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 → 64980-0330-04. 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), 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

LabelerRISING PHARMA HOLDINGS, INC.
Application holderRISING PHARMA HOLDINGS INC
FDA applicationANDA090982 (ANDA)
Labeler code64980
First marketedJul 2016
Product typeHuman Prescription Drug
Portfolio525 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% SCALP OIL Ingredient Fluocinolone/Shower Cap
📖 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 →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII N6K5787QVP
    Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
  • UNII 7L6R1SQ6M0
    Oleth-2 is a synthetic chemical made by combining ethylene oxide with oleyl alcohol. It works as an emulsifier and surfactant, helping mix oil and water-based ingredients together in medicines and allowing better absorption through the skin.
  • UNII 5TL50QU0W4
    Peanut oil is a plant-based oil extracted from peanuts. It's used in medicines as a solvent and carrier to dissolve or suspend active ingredients, making them easier to deliver and absorb in the body.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.168 $19.85 / 118.28 ml
Medicaid paysCMS SDUD · 12 mo $0.2616 $30.94 / 118.28 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.302 $0.162
▼ Down 44% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
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/mLthis 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 +6%
Fluocinolone Acetonide .11 mg/118.28mL 51672-1356-08 Sun 1 bottle $0.178 AT Availability likely +6%
Fluocinolone Acetonide Oil .11 mg/mL 64980-0331-04 Rising 118.28 ml $0.178 AT Availability likely +6%
Fluocinolone Acetonide .11 mg/mL 70752-0156-06 Quagen 1 bottle $0.178 AT Availability likely +6%
Fluocinolone Acetonide .11 mg/118.28mL 65162-0703-86 Amneal 1 bottle $0.222 Discontinued +32%
Fluocinolone Acetonide .11 mg/mL 68462-0590-89 Glenmark 1 bottle $0.222 FDA listed +32%
Derma-Smoothe/Fs .11 mg/mL 68791-0102-04 Royal 1 bottle $0.242 AT Availability likely +44%
Derma-Smoothe/FS .11 mg/mL 68791-0101-04 Royal 1 bottle $0.242 AT Availability likely +44%
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/mL 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

🏛️
2016
On the market since
Jul 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 64980-0330-04, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
29.4K
Units reimbursed last 4 qtrs
3.5M
Gross reimbursed last 4 qtrs
$928.1K
Avg / prescription
$31.59
Avg / unit
$0.2616
Latest quarter Q4 2025
7.6KRx
Medicaid pays / mL
$0.2616
gross reimbursed
vs
NADAC / mL
$0.1678
acquisition cost
=
Spread
+$0.0938
+56% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
40% FFS 60% MCO
Fee-for-service · 11,748 Rx Managed care · 17,630 Rx
State Medicaid map
Alaska: 2,839 units · 387 per 100k residents AK Maine: no data reported ME Washington: 20,817 units · 266 per 100k residents WA Idaho: 10,645 units · 542 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 195,040 units · 3,400 per 100k residents MN Wisconsin: no data reported WI Michigan: 20,935 units · 209 per 100k residents MI New York: 142,124 units · 726 per 100k residents NY Vermont: 8,161 units · 1,261 per 100k residents VT New Hampshire: no data reported NH Oregon: 10,879 units · 257 per 100k residents OR Nevada: 18,097 units · 567 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 37,613 units · 1,173 per 100k residents IA Illinois: 244,954 units · 1,952 per 100k residents IL Indiana: 19,275 units · 281 per 100k residents IN Ohio: 244,366 units · 2,074 per 100k residents OH Pennsylvania: 83,644 units · 645 per 100k residents PA New Jersey: 7,688 units · 82.8 per 100k residents NJ Massachusetts: 42,347 units · 605 per 100k residents MA California: 932,385 units · 2,393 per 100k residents CA Utah: 11,946 units · 350 per 100k residents UT Colorado: 1,301 units · 22.1 per 100k residents CO Nebraska: no data reported NE Missouri: 66,592 units · 1,075 per 100k residents MO Kentucky: no data reported KY West Virginia: 9,936 units · 561 per 100k residents WV Virginia: 115,556 units · 1,326 per 100k residents VA Maryland: 155,310 units · 2,513 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 52,988 units · 2,507 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 93,441 units · 1,311 per 100k residents TN North Carolina: 250,992 units · 2,316 per 100k residents NC South Carolina: 123,596 units · 2,300 per 100k residents SC Delaware: 28,156 units · 2,731 per 100k residents DE Oklahoma: no data reported OK Louisiana: 75,697 units · 1,655 per 100k residents LA Mississippi: no data reported MS Alabama: 114,850 units · 2,248 per 100k residents AL Georgia: 181,551 units · 1,646 per 100k residents GA D.C.: 7,100 units · 1,046 per 100k residents DC Hawaii: 5,086 units · 354 per 100k residents HI Texas: 212,546 units · 697 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
22.13,400
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Minnesota 3,400 /100k
2 Delaware 2,731 /100k
3 Maryland 2,513 /100k
4 New Mexico 2,507 /100k
5 California 2,393 /100k
6 North Carolina 2,316 /100k
7 South Carolina 2,300 /100k
8 Alabama 2,248 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Fluocinolone Acetonide Oil — the program that covers self-administered drugs. 4 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 Oil. 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
$2M
Claims incl. refills
60.5K
Beneficiaries
54.1K
Spend / beneficiary
$37.04
Spend / claim
$33.14
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Fluocinolone Acetonide Oil (this brand).

Top reported reactions

Pruritus154
Rash138
Diarrhoea114
Psoriasis96
Fatigue88
Headache86
Pain79

Age at onset

Neonate1
Infant7
Child67
Adolescent45
Adult348
Elderly146

Reporter sex

1,636 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Life-threatening42
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 215 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
64980-0330-04 You're viewing this 118.28 mL in 1 BOTTLE (64980-330-04) 2016-07-18 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 40 words

1 INDICATIONS AND USAGE Fluocinolone acetonide topical oil, 0.01% is indicated for the treatment of psoriasis of the scalp in adults. Fluocinolone acetonide topical oil, 0.01% is a corticosteroid indicated for the treatment of psoriasis of the scalp in adults.

⏱️ Dosage and Administration ~1 min read

2 DOSAGE AND ADMINISTRATION Fluocinolone acetonide topical oil, 0.01% is for topical use only. Not for oral, ophthalmic, or intravaginal use. Wet or dampen hair and scalp thoroughly.

Apply a thin film of fluocinolone acetonide topical oil, 0.01% on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours then wash hair with regular shampoo and rinse thoroughly. Use daily as needed.

Discontinue fluocinolone acetonide topical oil, 0.01% when control of disease is achieved within 2 weeks, or contact the healthcare provider if no improvement is seen within 2 weeks. Do not use fluocinolone acetonide topical oil, 0.01% on the face unless directed by the healthcare provider. Do not apply to intertriginous areas due to the increased risk of local adverse reactions [see Adverse Reactions ( 6 )].

Do not apply to the diaper area; diapers or plastic pants may constitute occlusive use. [see Warnings and Precautions ( 5.1 )] Fluocinolone acetonide topical oil, 0.01% is not for oral, ophthalmic, or intravaginal use. ( 2 ) Do not use on face or intertriginous areas. ( 2 ) Apply a thin film of fluocinolone acetonide topical oil, 0.01% on the wet scalp, massage well and cover scalp with the supplied shower cap.

Leave on overnight or for a minimum of 4 hours before washing off. ( 2 )

💊 Dosage Forms and Strengths 55 words

3 DOSAGE FORMS AND STRENGTHS Fluocinolone acetonide topical oil, 0.01% is a topical oil containing 0.01% fluocinolone acetonide, supplied in bottles containing 4 fluid ounces and with 2 shower caps. Fluocinolone acetonide topical oil, 0.01% is a topical oil containing 0.01% fluocinolone acetonide, supplied in bottles containing 4 fluid ounces and with 2 shower caps.

Contraindications 4 words

4 CONTRAINDICATIONS None. None.

⚠️ Warnings and Cautions ~2 min read

5 WARNINGS AND PRECAUTIONS Endocrine System Adverse Reactions: o Topical corticosteroids can produce reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria. ( 5.1 ) o Systemic absorption may require evaluation for hypothalamic-pituitary-adrenal (HPA) axis suppression. Potent corticosteroids use on large areas, prolonged use or occlusive use, altered skin barrier, liver failure, and young age may increase systemic absorption.

Modify use should HPA axis suppression develop. ( 5.1 ) Local Adverse Reactions: 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 , 6.1 ) Ophthalmic Adverse Reactions: May increase the risks of glaucoma and posterior subcapsular cataract.

Avoid contact of fluocinolone acetonide topical oil, 0.01% with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. ( 5.3 )

5.1Endocrine System Adverse Reactions 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 result from systemic absorption of topical corticosteroids. HPA axis suppression and Cushing's syndrome have been reported in patients receiving topical corticosteroids.

Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, use of occlusive dressings, altered skin barrier, liver failure, and young age. Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure. 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. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.

Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.

5.2Local Adverse Reactions Local adverse reactions may occur with use of topical corticosteroids, including fluocinolone acetonide topical oil, 0.01%, 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 )].

5.3Ophthalmic Adverse Reactions Use of topical corticosteroids may increase the risks of glaucoma and posterior subcapsular cataract. Glaucoma and cataracts have been reported in postmarketing experience with the use of topical corticosteroid products. Avoid contact of fluocinolone acetonide topical oil, 0.01% with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

5.4Allergic Contact Dermatitis Use of topical corticosteroids can cause allergic contact dermatitis. 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.

5.5Concomitant Skin Infections Use of topical corticosteroids may delay healing or worsen concomitant skin infections. Treat concomitant skin infections with an appropriate antimicrobial agent.…

🤒 Adverse Reactions ~2 min read

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of the labeling: • Endocrine System Adverse Reactions [see Warnings and Precautions ( 5.1 )] • Local Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Ophthalmic Adverse Reactions [see Warnings and Precautions ( 5.3 )] The most common adverse reactions in pediatric subjects treated for atopic dermatitis (≥5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%).

( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience Because clinical trials are conducted under widely varying condition, 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. An open-label safety study was conducted in 29 pediatric subjects 3 months to 2 years old to assess the HPA axis by ACTH stimulation testing following use of the formulation of fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks.

Fluocinolone acetonide topical oil, 0.01% is not approved for use in pediatric patients for the treatment of psoriasis of the scalp. The most common adverse reactions were reported in the study: Table 1: Adverse Reactions in ≥2% Pediatric Subjects 3 Months to 2 Years of Age Treated with the Formulation of Fluocinolone Acetonide Topical Oil, 0.01%, N=30* Adverse Reaction n (%) Cough 6 (20) Rhinorrhea 4 (13) Pyrexia 3 (10) Nasopharyngitis 2 (7) Hypopigmentation 2 (7) Abscess 1 (3) Atopic Dermatitis 1 (3) Eczema 1 (3) Hyperpigmentation 1 (3) Molluscum 1 (3) Rash 1 (3) Diarrhea 1 (3) Otitis Media 1 (3) URI 1 (3) Vomiting 1 (3) *Includes one subject who withdrew at Week 2

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of products containing topical corticosteroids. Because postmarketing adverse 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. Endocrine Disorders: HPA axis suppression and Cushing’s syndrome Eye Disorders: glaucoma and cataracts Nervous System Disorders: intracranial hypertension including bulging fontanelles, headaches, and bilateral papilledema

👥 Use in Specific Populations ~2 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from case reports, case series, and observational studies on fluocinolone acetonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Observational studies suggest maternal use of high to super-high potency topical steroids may be associated with an increased risk of low birthweight infants. Advise pregnant women to use fluocinolone acetonide topical oil, 0.01% on the smallest area of skin and for the shortest duration possible.

Corticosteroids can cause fetal malformations in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids cause fetal malformations after dermal application in laboratory animals. The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2Lactation Risk Summary There is no information regarding the presence of fluocinolone acetonide in breast milk or its effects on the breastfed infant or on milk production. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. To minimize potential exposure to the breastfed infant via breast milk, use fluocinolone acetonide topical oil, 0.01% on the smallest area of skin and for the shortest duration possible while breastfeeding.

Advise breastfeeding women not to apply fluocinolone acetonide topical oil, 0.01% directly to the nipple and areola to avoid direct infant exposure [see Warnings and Precautions ( 5.1 )]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for fluocinolone acetonide topical oil, 0.01% and any potential adverse effects on the breastfed infant from fluocinolone acetonide topical oil, 0.01% or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of fluocinolone acetonide topical oil, 0.01% have not been established in pediatric patients with psoriasis of the scalp. Evaluation in Peanut-Sensitive Pediatric Patients A clinical trial was conducted to assess the safety of the formulation of fluocinolone acetonide topical oil, 0.01%, which contains refined peanut oil, in patients with known peanut allergies. The trial enrolled 13 pediatric subjects with atopic dermatitis, 6 to 17 years of age.

Fluocinolone acetonide topical oil, 0.01% is not approved for the treatment of atopic dermatitis. Of the 13 subjects, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The trial evaluated the subjects’ responses to both prick test and patch test utilizing refined peanut oil, the formulation of fluocinolone acetonide topical oil, 0.01% and histamine/saline controls.

Subjects were also treated with the formulation of fluocinolone acetonide topical oil, 0.01% twice daily for 7 days. Prick test and patch test results for all 13 subjects were negative to the formulation of fluocinolone acetonide topical oil, 0.01% and the refined peanut oil. One of the 9 peanut-sensitive subjects experienced an exacerbation of atopic dermatitis after 5 days of use on the formulation of fluocinolone acetonide topical oil, 0.01%.

🤰 Pregnancy 167 words

8.1Pregnancy Risk Summary Available data from case reports, case series, and observational studies on fluocinolone acetonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Observational studies suggest maternal use of high to super-high potency topical steroids may be associated with an increased risk of low birthweight infants. Advise pregnant women to use fluocinolone acetonide topical oil, 0.01% on the smallest area of skin and for the shortest duration possible.

Corticosteroids can cause fetal malformations in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids cause fetal malformations after dermal application in laboratory animals. The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

🧒 Pediatric Use 205 words

8.4Pediatric Use The safety and effectiveness of fluocinolone acetonide topical oil, 0.01% have not been established in pediatric patients with psoriasis of the scalp. Evaluation in Peanut-Sensitive Pediatric Patients A clinical trial was conducted to assess the safety of the formulation of fluocinolone acetonide topical oil, 0.01%, which contains refined peanut oil, in patients with known peanut allergies. The trial enrolled 13 pediatric subjects with atopic dermatitis, 6 to 17 years of age.

Fluocinolone acetonide topical oil, 0.01% is not approved for the treatment of atopic dermatitis. Of the 13 subjects, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The trial evaluated the subjects’ responses to both prick test and patch test utilizing refined peanut oil, the formulation of fluocinolone acetonide topical oil, 0.01% and histamine/saline controls.

Subjects were also treated with the formulation of fluocinolone acetonide topical oil, 0.01% twice daily for 7 days. Prick test and patch test results for all 13 subjects were negative to the formulation of fluocinolone acetonide topical oil, 0.01% and the refined peanut oil. One of the 9 peanut-sensitive subjects experienced an exacerbation of atopic dermatitis after 5 days of use on the formulation of fluocinolone acetonide topical oil, 0.01%.

🧬 Clinical Pharmacology 197 words

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 in psoriasis of the scalp is unknown.

12.2Pharmacodynamics Vasoconstrictor Assay Fluocinolone acetonide topical oil, 0.01% is in the low to medium range of potency as compared with other topical corticosteroids in vasoconstrictor studies. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression HPA axis suppression following administration of fluocinolone acetonide topical oil, 0.01% was not assessed.

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.

🧬 Mechanism of Action 30 words

12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in psoriasis of the scalp is unknown.

📦 How Supplied / Storage and Handling 49 words

16 HOW SUPPLIED / STORAGE AND HANDLING Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) (NDC # 64980-330-04) is supplied in bottles containing 4 fluid ounces and with 2 shower caps. Storage: Keep tightly closed. Store at 20°-25°C (68°-77°F); excursions permitted to 15°- 30°C (59°-86°F) [see USP Controlled Room Temperature].

📋 Description 189 words

11 DESCRIPTION Fluocinolone Acetonide Topical Oil, 0.01% (Scalp 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. 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% 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. Each packaged product contains 2 shower caps.

The shower cap is made of low density polyethylene material with rubber elastic. Fluocinolone acetonide topical oil, 0.01% is formulated with 48% refined peanut oil. The bulk refined peanut oil used in fluocinolone acetonide topical oil, 0.01% is heated between 232°C - 246°C (450°F - 475°F) for at least 15 minutes which should provide for adequate decomposition of allergenic proteins. structure.jpg

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.