Fluticasone Propionate .05 mg/g Ointment — NDC 45802-221-11 (Billing 45802-0221-11)
This is a package of Fluticasone Propionate .05 mg/g Ointment from Padagis Israel Pharmaceuticals Ltd, marketed since Jul 2007 and currently FDA-listed; retail pharmacies pay about $0.4325 per g (NADAC).
NDC database record
One package, one record: these facts belong to NDC 45802-221-11 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 45802 labeler · 221 product · 11 package
- Package marketed since
- Jul 9, 2007
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 4580222111 7
- Medicaid fills, this package
- 1,183 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Fluticasone Propionate (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): 016255
- GCN: 48641
- GPI-14 (Medi-Span): 90550068104210
- HICL (First Databank): 007873
- AHFS class code: 84:06.08.00
- RxCUI (RxNorm): 895487
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 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
Fluticasone topical is used to reduce inflammation and relieve itching, redness, dryness, and scaling associated with 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). Fluticasone 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 product. Inhalers and powders are for long-term asthma control, nasal sprays are for allergy or nasal symptoms, and skin products calm inflamed, itchy skin. Check...
- No. It does not relieve sudden breathing trouble. Use your rescue medicine as directed and call your doctor if episodes do not respond to it.
- Can I use my fluticasone inhaler for an asthma attack?
- Inhaled steroids can cause thrush, a yeast infection in the mouth and throat. Rinsing with water and spitting it out after each dose helps lower that risk.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Fluticasone Propionate — tap one for details:
Fluticasone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 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 g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.433 | $12.98 / 30 g |
| Medicaid paysCMS SDUD · 12 mo | $0.7149 | $21.45 / 30 g |
| Medicare drug plans payPart D · Q2 2026 | $0.5199 | $15.60 / 30 g |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 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 | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 45802-0221-11 You're viewing this | 1 TUBE in 1 CARTON / 30 g in 1 TUBE | $0.4325 / g | $12.98 | 2007-07-09 | — | Active |
| 45802-0221-35 45802-221-35 | 1 TUBE in 1 CARTON / 15 g in 1 TUBE | $0.5415 / g | $8.12 | 2008-02-12 | — | Active |
| 45802-0221-37 45802-221-37 Main listing | 1 TUBE in 1 CARTON / 60 g in 1 TUBE | $0.3648 / g | $21.89 | 2007-10-31 | — | Active |
Per g, this pack runs about 19% above the cheapest pack (NDC 45802-0221-37, $0.3648 vs $0.4325 NADAC).
This pack accounts for about 26% of this product's recent Medicaid fills; the largest share goes to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Fluticasone Propionate .05 mg/g Ointment?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fluticasone Propionate .05 mg/gthis 45802-0221-11 | Padagis | 1 tube | $0.433 | AB | Availability likely | — |
| Fluticasone Propionate .05 mg/g 00713-0632-15 | Cosette | 1 tube | $0.541 | AB | Availability likely | +25% |
| Fluticasone Propionate .05 mg/g 63629-8661-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Fluticasone Propionate .05 mg/g 63629-8662-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Fluticasone Propionate .05 mg/g 63629-8663-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Fluticasone Propionate .05 mg/g 72162-1401-02 | Bryant | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
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
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 Fluticasone 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 XOF597Q3KY
A refined form of wax made from petroleum, microcrystalline wax is used in medicines as a coating agent, binder, and hardening ingredient. It helps give tablets and capsules their shape and protective outer layer.
-
UNII T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 0W8RRI5W5A
A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 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 Padagis Israel Pharmaceuticals Ltd labeler code 45802
- Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl 14 g/100g; 74.9 g/100g; .25 g/100g Ointment NDC 45802-188-16
- Childrens Acetaminophen 160 mg/5mL Suspension NDC 45802-201-26
- ESTRADIOL .5 mg/.5g Gel NDC 45802-202-30
- nitroglycerin lingual 400 ug Spray NDC 45802-210-01
- alogliptin and metformin hydrochloride 12.5 mg; 1000 mg Tablet, Film Coated NDC 45802-211-72
- benzoyl peroxide 5 g/100g Gel NDC 45802-216-01
- Fluticasone Propionate .5 mg/g Cream NDC 45802-222-11
- nystatin and triamcinolone acetonide 100000 [USP'U]/g; 1 mg/g Ointment NDC 45802-244-14
- Mometasone Furoate 1 mg/g Cream NDC 45802-257-35
- Alogliptin and Pioglitazone 12.5 mg; 30 mg Tablet, Film Coated NDC 45802-260-65
- Clindamycin Phosphate 10 mg/mL Solution NDC 45802-263-37
- Permethrin 50 mg/g Cream NDC 45802-269-37
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Fluticasone propionate ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients. Fluticasone propionate ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Apply a thin film of fluticasone propionate ointment to the affected skin areas twice daily. Rub in gently. Avoid use with occlusive dressing. Fluticasone propionate ointment is for topical use only; it is not for ophthalmic, oral, or intravaginal use. Apply a thin film to affected skin areas twice daily. ( 2 ) Not for ophthalmic, oral or intravaginal use. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ointment, 0.005%. Each gram of fluticasone propionate ointment contains 0.05 mg fluticasone propionate in a white to off-white translucent ointment base. Ointment, 0.005%. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Fluticasone propionate ointment is contraindicated in patients with a history of hypersensitivity to any of the components in the preparation. History of serious hypersensitivity to fluticasone propionate, or any other components of fluticasone propionate ointment. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression: Reversible HPA axis suppression and resulting clinical glucocorticoid insufficiency can occur during or after withdrawal of treatment. Risk factors include use over large surface area, prolonged use, use under occlusion, altered skin barrier, liver failure, and young age. Modify use if HPA axis suppression is suspected.
( 5.1 ) • Local adverse reactions with topical corticosteroids may occur more frequently with the use of occlusive dressings, prolonged use, or use of higher potency corticosteroids. These reactions include: irritation, dryness, acneiform eruptions, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. ( 5.2 ) • Ophthalmic Adverse Reactions: May increase the risk of cataract and glaucoma.
If visual symptoms occur, consider referral to an ophthalmologist. ( 5.5 )
5.1Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects Topical corticosteroids, including fluticasone propionate ointment, can produce reversible HPA axis suppression with the potential for clinical glucocorticoid insufficiency. Factors that predispose to HPA axis suppression include large treatment surface areas, prolonged use, use under occlusion, altered skin barrier, liver failure, and young age. Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.
HPA axis suppression may occur during or after withdrawal of treatment. If HPA axis suppression is suspected, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Evaluation of HPA axis suppression may be done by using the cosyntropin stimulation test.
Pediatric patients may be at greater risk of HPA axis suppression due to their higher skin surface area to body mass ratios [see Use in Specific Populations ( 8.4 ) ].
5.2Local Adverse Reactions The following local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, hypertrichosis, and miliaria.
5.3Allergic Contact Dermatitis Allergic contact dermatitis with topical corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation can be corroborated with appropriate diagnostic patch testing. Discontinue fluticasone propionate ointment if appropriate.
5.4Skin Infections If concomitant skin infections are present or develop, use an appropriate antimicrobial. If a favorable response does not occur promptly, discontinue use of fluticasone propionate ointment until the infection has been adequately controlled.
5.5Ophthalmic Adverse Reactions Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported postmarketing with the use of topical corticosteroids. Avoid contact of fluticasone propionate ointment with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • HPA Axis Suppression and Other Adverse Endocrine Effects [see Warnings and Precautions ( 5.1 ) ] • Local Adverse Reactions [see Warnings and Precautions ( 5.2 ) ] • Concomitant Skin Infections [see Warnings and Precautions ( 5.4 ) ] The most common adverse reactions (<1%) were pruritus, burning, hypertrichosis, increased erythema, urticaria, irritation, and lightheadedness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In controlled clinical trials, the total incidence of adverse reactions associated with the use of fluticasone propionate ointment was approximately 4%. These adverse reactions were usually mild, self-limiting, and consisted primarily of pruritus, burning, hypertrichosis, increased erythema, urticaria, irritation, and lightheadedness.
Each of these events occurred individually in less than 1% of subjects.
6.2Postmarketing Experience Because these 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. The following local adverse reactions have been identified during post-approval use of fluticasone propionate ointment: acneiform dermatitis, edema, rash, hypoaesthesia, pustular psoriasis, skin atrophy. The following systemic adverse reactions have been identified during post-approval use of fluticasone propionate ointment: immunosuppression/ Pneumocystis jirovecii /pneumonia/leukopenia/thrombocytopenia; hyperglycemia/glycosuria; Cushing syndrome; generalized body edema/blurred vision; and acute urticarial reaction (edema, urticaria, pruritus, and throat swelling).
The following local adverse reactions have also been reported with the use of topical corticosteroids: telangiectasia, striae, dryness, folliculitis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Ophthalmic adverse reactions including cataracts, glaucoma and increased intraocular pressure have been reported with the use of topical corticosteroids.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on fluticasone propionate ointment use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroids during pregnancy (see Data) . Advise pregnant women that fluticasone propionate ointment may increase the risk of having a low birthweight infant and to use fluticasone propionate ointment on the smallest area of skin and for the shortest duration possible.
In animal reproduction studies, subcutaneous administration of fluticasone propionate to pregnant mice, rats, and rabbits during organogenesis caused malformations characteristic of corticosteroids in each species (see Data) . The available data do not allow the calculation of relevant comparisons between the systemic exposure of fluticasone propionate observed in animal studies to the systemic exposure that would be expected in humans after topical use of fluticasone propionate ointment. The background risk of major birth defects and miscarriage for the indicated population(s) 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. Data Human Data Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency.
However, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 grams during the entire pregnancy, maternal use was associated with an increased risk of low birth weight infants. Animal Data In embryo-fetal development studies, pregnant rabbits, rats, and mice received subcutaneous doses of fluticasone propionate during organogenesis at doses up to 4, 100, and 150 μg/kg/day, respectively. A malformation characteristic of corticosteroids (cleft palate) was noted at the high dose in each species.
Additional adverse effects were noted in rats and rabbits. Decreased fetal weights and retarded skeletal ossification were noted in rabbits at 4 μg/kg/day and rats at 100 μg/kg/day. Maternal toxicity and omphalocele were also noted in rats at 100 μg/kg/day.
No malformations or developmental toxicity was noted in rabbits at 0.57 μg/kg/day, in rats at 10 μg/kg/day, or in mice at 15 μg/kg/day. Fluticasone propionate crossed the placenta following administration of a subcutaneous or an oral dose of 100 μg/kg tritiated fluticasone propionate to pregnant rats.
8.2Lactation Risk Summary There are no data on the presence of fluticasone propionate in human milk, its effects on the breastfed infant, or its effects on milk production. It is not known whether topical administration of fluticasone propionate ointment could result in sufficient systemic absorption to produce detectable quantities in human milk (see Clinical Considerations ). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for fluticasone propionate ointment and any potential adverse effects on the breastfed child from fluticasone propionate ointment or from the underlying maternal condition.
Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use fluticasone propionate ointment on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply fluticasone propionate ointment directly to the nipple and areola prior to breastfeeding to avoid direct infant exposure [see Use in Specific Populations ( 8.4 ) ].
8.4Pediatric Use The safety and effectiveness… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on fluticasone propionate ointment use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroids during pregnancy (see Data) . Advise pregnant women that fluticasone propionate ointment may increase the risk of having a low birthweight infant and to use fluticasone propionate ointment on the smallest area of skin and for the shortest duration possible.
In animal reproduction studies, subcutaneous administration of fluticasone propionate to pregnant mice, rats, and rabbits during organogenesis caused malformations characteristic of corticosteroids in each species (see Data) . The available data do not allow the calculation of relevant comparisons between the systemic exposure of fluticasone propionate observed in animal studies to the systemic exposure that would be expected in humans after topical use of fluticasone propionate ointment. The background risk of major birth defects and miscarriage for the indicated population(s) 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. Data Human Data Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency.
However, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 grams during the entire pregnancy, maternal use was associated with an increased risk of low birth weight infants. Animal Data In embryo-fetal development studies, pregnant rabbits, rats, and mice received subcutaneous doses of fluticasone propionate during organogenesis at doses up to 4, 100, and 150 μg/kg/day, respectively. A malformation characteristic of corticosteroids (cleft palate) was noted at the high dose in each species.
Additional adverse effects were noted in rats and rabbits. Decreased fetal weights and retarded skeletal ossification were noted in rabbits at 4 μg/kg/day and rats at 100 μg/kg/day. Maternal toxicity and omphalocele were also noted in rats at 100 μg/kg/day.
No malformations or developmental toxicity was noted in rabbits at 0.57 μg/kg/day, in rats at 10 μg/kg/day, or in mice at 15 μg/kg/day. Fluticasone propionate crossed the placenta following administration of a subcutaneous or an oral dose of 100 μg/kg tritiated fluticasone propionate to pregnant rats.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of fluticasone propionate ointment have not been established in pediatric patients. Use of fluticasone propionate ointment in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic effects when treated with topical drugs.
They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency upon the use of topical corticosteroids [see Warnings and Precautions ( 5.1 ) ]. In a trial of 35 pediatric subjects treated with fluticasone propionate ointment, 0.005% for atopic dermatitis over at least 35% of body surface area, subnormal adrenal function was observed with cosyntropin stimulation testing at the end of 3 to 4 weeks of treatment in 4 subjects who had normal testing prior to treatment. It is not known if these subjects had recovery of adrenal function because follow-up testing was not performed.
The decreased responsiveness of cosyntropin testing was not correlated to age of subject, amount of fluticasone propionate ointment used, or serum levels of fluticasone propionate. In the above trial, telangiectasia on the face was noted in one subject on the eighth day of a 4-week treatment period. Facial use was discontinued and the telangiectasia resolved.
HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids.
🧓 Geriatric Use ▾
8.5Geriatric Use A limited number of patients above 65 years of age (n=203) have been treated with fluticasone propionate ointment in US and non-US clinical trials. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.
🧬 Clinical Pharmacology ▾
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 of fluticasone propionate ointment in corticosteroid-responsive dermatoses is unknown.
12.2Pharmacodynamics Vasoconstrictor Assay Studies performed with fluticasone propionate ointment indicate that it is in the medium range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.
12.3Pharmacokinetics Absorption The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressing enhances penetration. Topical corticosteroids can be absorbed from normal intact skin.
Inflammation and/or other disease processes in the skin increase percutaneous absorption. In a study of 6 healthy subjects applying 25 g of fluticasone propionate ointment 0.005% twice daily to the trunk and legs for up to 5 days under occlusion, plasma levels of fluticasone ranged from 0.08 to 0.22 ng/mL. Distribution The percentage of fluticasone propionate bound to human plasma proteins averaged 91%.
Fluticasone propionate is weakly and reversibly bound to erythrocytes. Fluticasone propionate is not significantly bound to human transcortin. Metabolism No metabolites of fluticasone propionate were detected in an in vitro study of radiolabeled fluticasone propionate incubated in human skin homogenate.
Fluticasone propionate is metabolized in the liver by cytochrome P450 3A4-mediated hydrolysis of the 5-fluoromethyl carbothioate grouping. This transformation occurs in 1 metabolic step to produce the inactive 17-β-carboxylic acid metabolite, the only known metabolite detected in man. This metabolite has approximately 2,000 times less affinity than the parent drug for the glucocorticoid receptor of human lung cytosol in vitro and negligible pharmacological activity in animal studies.
Other metabolites detected in vitro using cultured human hepatoma cells have not been detected in man.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of fluticasone propionate ointment in corticosteroid-responsive dermatoses is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Fluticasone Propionate Ointment, 0.005% is a white to off-white translucent ointment supplied as follows: 15 g tube (NDC 45802- 221 -35) 30 g tube (NDC 45802- 221 -11) 60 g tube (NDC 45802- 221 -37) Store at 20-25°C (68-77°F)
📋 Description ▾
11 DESCRIPTION Fluticasone Propionate Ointment, 0.005% contains fluticasone propionate [ S -Fluoromethyl 6α, 9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate], a synthetic fluorinated corticosteroid, for topical use. Chemically, fluticasone propionate is C 25 H 31 F 3 O 5 S. It has the following structural formula: Fluticasone propionate has a molecular weight of 500.6.
It is a white to off-white powder and is insoluble in water. Each gram of fluticasone propionate ointment contains fluticasone propionate 0.05 mg in a white to off-white translucent ointment base of liquid paraffin, microcrystalline wax, propylene glycol, and sorbitan sesquioleate. Structural Formula Image
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Advise the patient: • Avoid contact with the eyes. • Do not bandage the treated skin area, or cover or wrap it to cause occlusion unless directed by the healthcare provider. • Report any signs of local adverse reaction to their healthcare provider. • Do not use on the face, underarms, or groin areas unless directed by the healthcare provider. • Advise a woman to use fluticasone propionate ointment on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding.
Advise breastfeeding women not to apply fluticasone propionate ointment directly to the nipple and areola to avoid direct infant exposure. Manufactured by Padagis ® Yeruham, Israel www.padagis.com Rev 11-23 57B00 RC PH2
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressing enhances penetration. Topical corticosteroids can be absorbed from normal intact skin.
Inflammation and/or other disease processes in the skin increase percutaneous absorption. In a study of 6 healthy subjects applying 25 g of fluticasone propionate ointment 0.005% twice daily to the trunk and legs for up to 5 days under occlusion, plasma levels of fluticasone ranged from 0.08 to 0.22 ng/mL. Distribution The percentage of fluticasone propionate bound to human plasma proteins averaged 91%.
Fluticasone propionate is weakly and reversibly bound to erythrocytes. Fluticasone propionate is not significantly bound to human transcortin. Metabolism No metabolites of fluticasone propionate were detected in an in vitro study of radiolabeled fluticasone propionate incubated in human skin homogenate.
Fluticasone propionate is metabolized in the liver by cytochrome P450 3A4-mediated hydrolysis of the 5-fluoromethyl carbothioate grouping. This transformation occurs in 1 metabolic step to produce the inactive 17-β-carboxylic acid metabolite, the only known metabolite detected in man. This metabolite has approximately 2,000 times less affinity than the parent drug for the glucocorticoid receptor of human lung cytosol in vitro and negligible pharmacological activity in animal studies.
Other metabolites detected in vitro using cultured human hepatoma cells have not been detected in man.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Vasoconstrictor Assay Studies performed with fluticasone propionate ointment indicate that it is in the medium range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In an oral (gavage) mouse carcinogenicity study, doses of 0.1, 0.3, and 1 mg/kg/day fluticasone propionate were administered to mice for 18 months. Fluticasone propionate demonstrated no tumorigenic potential at oral doses up to 1 mg/kg/day in this study. In a dermal mouse carcinogenicity study, 0.05% fluticasone propionate ointment (40 μl) was topically administered for 1, 3 or 7 days/week for 80 weeks.
Fluticasone propionate demonstrated no tumorigenic potential at dermal doses up to 6.7 μg/kg/day in this study. Fluticasone propionate was not mutagenic or clastogenic in five in vitro genotoxicity tests (Ames assay, E. coli fluctuation test, S. cerevisiae gene conversion test, Chinese hamster ovary cell chromosome aberration assay and human lymphocyte chromosome aberration assay) and one in vivo genotoxicity test (mouse micronucleus assay). In a fertility study, male and female rats received subcutaneous doses of fluticasone propionate at doses up to 50 μg/kg/day.
No impairment of fertility or mating performance was observed.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In an oral (gavage) mouse carcinogenicity study, doses of 0.1, 0.3, and 1 mg/kg/day fluticasone propionate were administered to mice for 18 months. Fluticasone propionate demonstrated no tumorigenic potential at oral doses up to 1 mg/kg/day in this study. In a dermal mouse carcinogenicity study, 0.05% fluticasone propionate ointment (40 μl) was topically administered for 1, 3 or 7 days/week for 80 weeks.
Fluticasone propionate demonstrated no tumorigenic potential at dermal doses up to 6.7 μg/kg/day in this study. Fluticasone propionate was not mutagenic or clastogenic in five in vitro genotoxicity tests (Ames assay, E. coli fluctuation test, S. cerevisiae gene conversion test, Chinese hamster ovary cell chromosome aberration assay and human lymphocyte chromosome aberration assay) and one in vivo genotoxicity test (mouse micronucleus assay). In a fertility study, male and female rats received subcutaneous doses of fluticasone propionate at doses up to 50 μg/kg/day.
No impairment of fertility or mating performance was observed.
📄 Patient Package Insert ▾
PATIENT INFORMATION Fluticasone Propionate (floo-TIK-a-sone PROE-pee-oh-nate) Ointment, 0.005% Important: Fluticasone propionate ointment is for use on skin only (topical). Do not get fluticasone propionate ointment near or in your eyes, mouth, or vagina. Read this Patient Information before you start using fluticasone propionate ointment and each time you get a refill.
There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is fluticasone propionate ointment?
Fluticasone propionate ointment is a prescription corticosteroid medicine used on the skin (topical) for the relief of inflammation and itching caused by certain skin conditions in adults. It is not known if fluticasone propionate ointment is safe and effective in children. Fluticasone propionate ointment is not recommended for use in children.
Before using fluticasone propionate ointment, tell your healthcare provider about all of your medical conditions, including if you: • have an allergy to any of the ingredients in fluticasone propionate ointment • have a skin infection at the site to be treated. You may also need medicine to treat the skin infection. • have adrenal gland problems • have liver problems • have diabetes • have thinning skin (atrophy) at the site to be treated • have cataracts or glaucoma • are pregnant or plan to become pregnant. It is not known if fluticasone propionate ointment will harm your unborn baby.
If you use fluticasone propionate ointment during pregnancy, use fluticasone propionate ointment on the smallest area of the skin and for the shortest time needed. • are breastfeeding or plan to breastfeed. It is not known if fluticasone propionate ointment can pass into your breast milk and harm your baby. Breastfeeding women should use fluticasone propionate ointment on the smallest area of skin and for the shortest time needed.
Do not apply fluticasone propionate ointment directly to the nipple and areola to avoid contact with your baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids.
How should I use fluticasone propionate ointment? • Use fluticasone propionate ointment exactly as your healthcare provider tells you to use it. • Apply a thin film of fluticasone propionate ointment to the affected area 2 times each day. Gently rub into your skin. • Do not bandage, cover, or wrap the treated area unless your healthcare provider tells you to. • Do not use fluticasone propionate ointment on your face, groin, underarms (armpits), unless your healthcare provider tells you to. • Wash your hands after applying fluticasone propionate ointment, unless your hands are being treated. • Tell your healthcare provider if your symptoms get worse with fluticasone propionate ointment or if your symptoms do not improve after 2 weeks of treatment.
What are possible side effects of fluticasone propionate ointment? Fluticasone propionate ointment may cause serious side effects, including: • Fluticasone propionate ointment can pass through your skin and may cause adrenal gland problems. This is more likely to happen if you use fluticasone propionate ointment for too long, use it over a large treatment area, use it with other topical medicines that contain corticosteroids, cover the treated area, or have liver failure.
Your healthcare provider may do blood tests to check your adrenal gland function during and after treatment with fluticasone propionate ointment. • Skin problems, including skin reactions or thinning of your skin (atrophy), skin infections, and allergic reactions (allergic contact dermatitis) at the treatment site. Tell your healthcare provider if you get any skin reactions such as pain, tend… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Warnings and Precautions, Ophthalmic Adverse Reaction ( 5.5 ) 03/2021
📄 Package Label / Principal Display Panel ▾
Principal Display Panel- Carton NDC 45802-221-35 Rx Only Fluticasone Propionate Ointment, 0.005% For Dermatologic Use Only. Not For Ophthalmic Use. NET WT 15 g The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. carton serialization-template.jpg