Fluocinolone acetonide .01 mg/100mL Oil, 1 bottle
Other active recalls for Fluocinolone Acetonide (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 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...
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Supplement & herbal interactions
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💊 What it looks like
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🧪 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.
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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.
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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.
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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.
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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.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient 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
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💲 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 each | Per 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. | |
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/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/100mLthis 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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72162-1412-02 You're viewing this | 1 BOTTLE in 1 CARTON (72162-1412-2) / 118.28 mL in 1 BOTTLE | 2024-03-13 | Active |
🧭 About this NDC listing & data coverage
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) | ✓ 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. |
Questions about this listing
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Where does this data come from?
📄 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: 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** Day 56*** 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) *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 Treatment ***Four Weeks Post Treatment
🤰 Pregnancy ▾
Pregnancy: Teratogenic effects: 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 ▾
Pediatric Use: Fluocinolone Acetonide Topical Oil, 0.01% may be used twice daily for up to 4 weeks in pediatric patients 2 years and older with moderate to severe atopic dermatitis. Fluocinolone Acetonide Topical Oil, 0.01% should not be applied to the diaper area. Application to intertriginous areas should be avoided due to the increased possibility of local adverse events such as striae, atrophy, and telangiectasia, which may be irreversible.
The smallest amount of drug needed to cover the affected areas should be applied. Long term safety in the pediatric population has not been established. Fluocinolone Acetonide Topical Oil, 0.01% is not recommended for use on the face (see ADVERSE REACTIONS section).
Because of a higher ratio of skin surface area to body mass, children are at a greater risk than adults of HPA-axis-suppression when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.
(see PRECAUTIONS ). HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios.
Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Fluocinolone Acetonide Topical Oil, 0.01% is formulated with 48% refined peanut oil NF.
Physicians should use caution in prescribing Fluocinolone Acetonide Topical Oil, 0.01% for peanut-sensitive individuals.
🆘 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% is supplied in bottles containing 4 fluid ounces. It is labeled as Scalp Oil NDC: 72162-1412-2: 118.28 mL in a BOTTLE Scalp Oil is supplied 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]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
📋 Description ▾
DESCRIPTION Fluocinolone Acetonide Topical Oil, 0.01% 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 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 in Fluocinolone Acetonide Topical Oil, 0.01% 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 NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.
💬 Information for Patients ▾
Information for Patients: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to 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. 2.
This medication should not be used for any disorder other than that for which it was prescribed. 3. Patients should promptly report to their physician any worsening of their skin condition.
4. Parents of pediatric patients should be advised not to use Fluocinolone Acetonide Topical Oil, 0.01% in the treatment of diaper dermatitis. Fluocinolone Acetonide Topical Oil, 0.01% should not be applied to the diaper area as diapers or plastic pants may constitute occlusive dressing.
5. This medication should not be used on the face, underarm, or groin unless directed by the physician. 6.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.