Flac Otic Oil fluocinolone acetonide .11 mg/mL Oil — NDC 39328-079-20 (Billing 39328-0079-20)
This is a package of Flac Otic Oil fluocinolone acetonide .11 mg/mL Oil from Patrin Pharma, Inc., marketed since Apr 2018 and currently FDA-listed; retail pharmacies pay about $1.32 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 39328-079-20 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 39328 labeler · 079 product · 20 package
- Package marketed since
- Apr 12, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 3932807920 8
- FDA record last changed
- Jul 24, 2026
Other active recalls for Fluocinolone Acetonide (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 060055
- GCN: 26056
- GPI-14 (Medi-Span): 87300018101720
- HICL (First Databank): 033338
- AHFS class code: 52:08.08.00
- RxCUI (RxNorm): 1191299
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It depends on the product. Creams, ointments and solutions calm itchy, inflamed skin. The oils treat atopic dermatitis or, for ear oil, chronic eczematous external otitis. Eye impl...
- Use the smallest amount that covers the area. Creams and ointments are usually a thin film a few times a day, and the oils follow their own schedule. If there's no improvement in 2...
- Tilt your head, gently pull your ear lobe back and up, and use the dropper to put in 5 drops. Stay tilted for about a minute, then pat away extra oil with a cotton ball. It's usual...
- Not the oil, unless your provider tells you to. Skin folds, armpits and groin carry a higher risk of side effects. Keep it out of your eyes, mouth and vagina.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $1.320 | $26.39 / 20 ml |
| 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?
- CMS NADAC weekly file · file of Feb 21, 2024
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 39328-0079-20 You're viewing this Main listing | 1 BOTTLE, DROPPER in 1 CARTON / 20 mL in 1 BOTTLE, DROPPER | 2018-04-12 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fluocinolone Acetonide .11 mg/mL 45802-0009-10 | Padagis | 1 bottle | $0.924 | AT | Availability likely | save 30% |
| Fluocinolone Acetonide Oil .11 mg/mL 64980-0329-20 | Rising | 20 ml | $0.924 | AT | Availability likely | save 30% |
| Fluocinolone Acetonide .11 mg/mL 70752-0159-20 | Quagen | 1 bottle | $0.924 | AT | Availability likely | save 30% |
| Dermotic .11 mg/mL 68791-0103-20 | Royal | 1 bottle | $1.129 | AT | Availability likely | save 14% |
| Flac Otic Oil .11 mg/mLthis 39328-0079-20 | Patrin | 1 bottle | $1.319 | AT | FDA listed | — |
| fluocinolone acetonide .11 mg/mL 68462-0185-56 | Glenmark | 1 bottle | $1.319 | — | FDA listed | — |
| Fluocinolone Acetonide .11 mg/mL 71335-2879-01 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Fluocinolone Acetonide .11 mg/mL 72162-2320-02 | Bryant | 1 bottle | — | AT | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Feb 21, 2024
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?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
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.
🧪 Avoiding an ingredient? See Fluocinolone inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 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.
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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?
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Patrin Pharma, Inc. labeler code 39328
- Calcitriol 1 ug/mL Solution NDC 39328-042-15
- Hyoscyamine Sulfate .125 mg Tablet, Orally Disintegrating NDC 39328-049-10
- Hyoscyamine Sulfate .125 mg Tablet NDC 39328-050-10
- Hyoscyamine Sulfate .125 mg Tablet NDC 39328-051-10
- Hyoscyamine Sulfate .375 mg Tablet, Extended Release NDC 39328-052-10
- Methylphenidate HCl 5 mg/5mL Solution NDC 39328-054-50
- PREGABALIN 20 mg/mL Solution NDC 39328-090-16
- Prenatal Plus Vitamins prenatal with ferrous fumarate and folic acid 924 ug; 276 ug; 120 mg; 10 ug; 10 mg; 1.84 mg; 3 mg; 20 mg; 10 mg Tablet NDC 39328-106-10
- Senna UD Sennosides 8.8 mg/5mL Syrup NDC 39328-120-50
- Hydrocortisone Acetate 30 mg Suppository NDC 39328-129-12
- Methylphenidate HCl 10 mg/5mL Solution NDC 39328-154-50
- Senna UD Sennosides 26.4 mg/15mL Syrup NDC 39328-220-50
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATION AND USAGE Fluocinolone acetonide oil, 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of fluocinolone acetonide oil, 0.01% into the affected ear. To apply, tilt head to one side so that the ear is facing up. Then gently pull the ear lobe backward and upward and apply 5 drops of fluocinolone acetonide oil, 0.01% into the ear.
Keep head tilted for about a minute to allow fluocinolone acetonide oil, 0.01% to penetrate lower into the ear canal. Gently pat excess material dripping out of the ear using a clean cotton ball. Follow these instructions twice each day for 7 to 14 days.
⛔ Contraindications ▾
CONTRAINDICATIONS Fluocinolone acetonide 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 ).
🤒 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 oil, 0.01%.
🤰 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 oil, 0.01%.
Therefore, fluocinolone acetonide 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 oil, 0.01% may be used twice daily for up to 2 weeks in pediatric patients 2 years of age and older with chronic eczematous external otitis. Fluocinolone acetonide 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 oil, 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing fluocinolone acetonide oil, 0.01% for peanut-sensitive individuals.
🆘 Overdosage ▾
OVERDOSAGE Topically applied fluocinolone acetonide 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 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. 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 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 Flac ® Otic Oil (fluocinolone acetonide oil, 0.01%) Ear Drops is supplied in 1 fluid ounce bottles containing 20 mL, net weight (Dropper Included) (NDC # 39328-079-20). Keep tightly closed. Store at 20°-25° C (68° to 77° F); excursions permitted to 15°-30° C (59°-86°F.) [see USP Controlled Room Temperature]. CAUTION: Rx only
📦 Storage and Handling ▾
Keep tightly closed. Store at 20°-25° C (68° to 77° F); excursions permitted to 15°-30° C (59°-86°F.) [see USP Controlled Room Temperature]. CAUTION: Rx only
📋 Description ▾
DESCRIPTION Flac ® Oil Ear Drops contain 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. This formulation is also marketed as fluocinolone acetonide oil, 0.01% (body oil) for the treatment of atopic dermatitis and fluocinolone acetonide oil, 0.01% (scalp oil) for the treatment of psoriasis of the scalp. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 .
It has the following structural formula: Fluocinolone acetonide in Fluocinolone Acetonide 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 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.
Chemical Structure
💬 Information for Patients ▾
Information for Patients Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external ear use only. Do not use occlusive dressings.
Avoid contact with the eyes. In case of contact, wash eyes liberally with water. This medication should not be used for any disorder other than that for which it was prescribed.
Patients should promptly report to their physician any worsening of their skin condition. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.
⚠️ Precautions ▾
PRECAUTIONS General Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.
This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Infrequently, signs and symptoms of glucocorticoid insufficiency may occur requiring supplemental systemic corticosteroids.
For information on systemic supplementation, see prescribing information for those products. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS-Pediatric use ).
Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than noting a clinical exacerbation, which may occur with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic testing. One peanut-sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with Fluocinolone Acetonide 0.01% Topical Oil (see CLINICAL STUDIES section).
If wheal and flare type reactions (which may be limited to pruritus) or other manifestations of hypersensitivity develop, fluocinolone acetonide oil, 0.01% should be discontinued immediately and appropriate therapy instituted. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of fluocinolone acetonide oil, 0.01% should be discontinued until the infection has been adequately controlled.
Fluocinolone acetonide oil, 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing fluocinolone acetonide oil, 0.01% for peanut-sensitive individuals. Information for Patients Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician.
It is for external ear use only. Do not use occlusive dressings. Avoid contact with the eyes.
In case of contact, wash eyes liberally with water. This medication should not be used for any disorder other than that for which it was prescribed. Patients should promptly report to their physician any worsening of their skin condition.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician. Laboratory Tests The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH stimulation test A.M. plasma cortisol test Urinary free cortisol test Carcinogenesis, mutagenesis, and impairment of fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of fluocinolone acetonide oil, 0.01%.
Studies have not been performed to evaluate the mutagenic potential of fluocinolone acetonide, the active ingredient in fluocinolone acetonide oil, 0.01%. Some corticosteroids have been found to be genotoxic in various genotoxicity tests (i.e. the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation, the in vivo mouse bone marrow micronucleus assay, the Chinese hamster micronucleus test and the in vitro mouse lymphoma gene mutation assay). Pregnancy Teratogenic effects P… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing 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 oil, 0.01% is administered to a nursing woman.
🧬 Pharmacokinetics ▾
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 oil, 0.01% is in the low to medium range of potency as compared with other topical corticosteroids
🔬 Clinical Studies ▾
CLINICAL STUDIES Efficacy in a placebo-controlled study for the treatment of chronic eczematous external otitis on 154 patients (adults and children 2 years of age and older) treated with five drops per ear of Fluocinolone Acetonide Oil, 0.01% twice daily, after 7 days of treatment, showed Fluocinolone Acetonide Oil, 0.01% to be superior to placebo in clearing the signs and symptoms of eczematous external otitis. Clinical safety studies were conducted on the same formulation of Fluocinolone Acetonide Oil, 0.01%, marketed as Fluocinolone Acetonide 0.01% Topical Oil.
Open-label safety studies on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis, and baseline body surface area involvement greater than 75% in 18 patients, and 50% to 75% in 15 patients, were treated with Fluocinolone Acetonide 0.01% Topical Oil twice daily for 41 weeks. Morning pre-stimulation cortisol level and post-Cortrosyn stimulation cortisol level 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¡g/dL; normal: cortisol > 7¡g/dL) but all had normal responses to 0.25 mg of Cortrosyn stimulation (cortisol > 18¡g/dL). A clinical study was conducted to assess the safety of Fluocinolone Acetonide 0.01% Topical Oil, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 patients with atopic dermatitis, 6 to 17 years of age.
Of the 13 patients, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The study evaluated the responses to both prick test and patch test utilizing peanut oil NF, Fluocinolone Acetonide 0.01% Topical Oil and histamine/saline controls on the 13 individuals. These subjects were also treated with Fluocinolone Acetonide 0.01% Topical Oil twice daily for 7 days.
Prick test and patch test results for all 13 patients were negative to Fluocinolone Acetonide 0.01% Topical Oil and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of Fluocinolone Acetonide 0.01% Topical Oil use. Importantly, the bulk peanut oil NF, used in Fluocinolone Acetonide 0.01% Topical Oil is heated at 475° F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, mutagenesis, and impairment of fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of fluocinolone acetonide oil, 0.01%. Studies have not been performed to evaluate the mutagenic potential of fluocinolone acetonide, the active ingredient in fluocinolone acetonide oil, 0.01%. Some corticosteroids have been found to be genotoxic in various genotoxicity tests (i.e. the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation, the in vivo mouse bone marrow micronucleus assay, the Chinese hamster micronucleus test and the in vitro mouse lymphoma gene mutation assay).
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton NDC 39328-079-20 Flac ® Otic Oil (fluocinolone acetonide oil) 0.01% Ear Drops For Otic Use Only Not for Ophthalmic Use Rx Only Net Wt. 20 mL PATRIN PHARMA PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton