Fluocinolone Acetonide .11 mg/mL Oil, 1 bottle
Other active recalls for Fluocinolone Acetonide (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
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 ↗- 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...
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
Where does this data come from?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.168 | $19.85 / 118.28 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.2502 | $29.59 / 118.28 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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/mLthis 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 | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70752-0158-06 You're viewing this | 1 BOTTLE in 1 CARTON (70752-158-06) / 118.28 mL in 1 BOTTLE | 2021-04-02 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATION AND USAGE Fluocinolone acetonide topical oil, 0.01% is a low to medium potency corticosteroid indicated: In adult patients for the treatment of psoriasis of the scalp (scalp oil).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Fluocinolone acetonide topical oil, 0.01% for scalp psoriasis in adults (scalp oil): For the treatment of scalp psoriasis, 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 before washing off. Wash hair with regular shampoo and rinse thoroughly.
⛔ Contraindications ▾
CONTRAINDICATIONS Fluocinolone acetonide topical oil, 0.01% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. This product contains refined peanut oil NF (see PRECAUTIONS section).
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.
One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with fluocinolone acetonide topical oil, 0.01%. A post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of fluocinolone acetonide topical oil, 0.01% when applied twice daily for 4 weeks to the face in children (2 to 12 years) with moderate to severe atopic dermatitis (see Table of Incidence of Adverse Events ). Incidence of Adverse Events (%) N=58 Adverse Event (AE) * # of patients (%) Day 14 Day 28 † D ay 56 ‡ * The number of individual adverse events reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse event. † End of Treat ment ‡ Four Weeks Post Treatment Any AE 15 (25.9) 6 (10.3) 7 (12.1) 7 (12.1) Telangiectasia 5 (8.6) 3 (5.2) 4 (6.9) 2 (3.5) Erythema 3 (5.2) 3 (5.2) Itching 3 (5.2) 3 (5.2) Irritation 3 (5.2) 3 (5.2) Burning 3 (5.2) 3 (5.2) Hypopigmentation 2 (3.5) 2 (3.5) Shiny skin 1 (1.7) 1 (1.7) Secondary atopic dermatitis 1 (1.7) 1 (1.7) Papules and pustules 1 (1.7) 1 (1.7) Keratosis pilaris 1 (1.7) 1 (1.7) Folliculitis 1 (1.7) 1 (1.7) Facial herpes simplex 1 (1.7) 1 (1.7) Acneiform eruption 1 (1.7) 1 (1.7) Ear infection 1 (1.7) 1 (1.7) 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.
🆘 Overdosage ▾
OVERDOSAGE Topically applied fluocinolone acetonide topical oil, 0.01% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 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 A 2 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 A 2 . Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier.
Occlusion of topical corticosteroids can enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Also, inflammation and/or other disease processes in the skin can increase percutaneous absorption.
Fluocinolone acetonide topical oil, 0.01% is in the low to medium range of potency as compared with other topical corticosteroids.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Fluocinolone acetonide topical oil, 0.01% (scalp oil) is supplied in bottles containing 4 fluid ounces. It is labeled as fluocinolone acetonide topical oil, 0.01% (scalp oil) (NDC # 70752-158-06) . Fluocinolone acetonide topical oil, 0.01% (scalp oil) is supplied with 2 shower caps.
Keep tightly closed. Store at 25°C (68° to 77°F); excursions permitted to 15°–30°C (59°–86° F) [see USP Controlled Room Temperature]. CAUTION: Rx Only Manufactured for: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52026 Rev.
04/21
📋 Description ▾
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. This formulation is also marketed as fluocinolone acetonide topical oil, 0.01% (body oil) for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% (ear drops) for 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% (scalp oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contain isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic. structure