FLUTICASONE PROPIONATE .5 mg/g Cream, 60 g
Other active recalls for Fluticasone Propionate (different manufacturers) — 2 · 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
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 ↗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?
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII I835H2IHHX
A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
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UNII 2DMT128M1S
A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII M629807ATL
Imidazolidinyl urea is a synthetic preservative that prevents microbial growth in medicines. It's used in formulations to extend shelf life and maintain product safety during storage.
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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 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 GR686LBA74
Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
9 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
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 g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.226 | $13.53 / 60 g |
| 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 · Q2 2026 | $0.3373 | $20.24 / 60 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fluticasone Propionate .5 mg/gthis 00168-0332-60 | E. | 60 g | $0.225 | AB | FDA listed | — |
| Fluticasone Propionate .5 mg/g 45802-0222-11 | Padagis | 1 tube | $0.245 | AB | Availability likely | +9% |
| Fluticasone Propionate .5 mg/g 00713-0631-15 | Cosette | 1 tube | $0.365 | AB | Availability likely | +62% |
| Fluticasone Propionate .5 mg/g 21922-0075-04 | Encube | 1 tube | $0.365 | AB | Availability likely | +62% |
| Fluticasone Propionate .5 mg/g 50090-1187-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Fluticasone Propionate .5 mg/g 63187-0959-15 | Proficient | 15 g | — | AB | FDA listed | — |
| Fluticasone Propionate .5 mg/g 63629-8658-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Fluticasone Propionate .5 mg/g 63629-8659-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Fluticasone Propionate .5 mg/g 63629-8660-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Fluticasone Propionate .5 mg/g 72162-1402-03 | Bryant | 1 tube | — | AB | 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 by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00168-0332-15 | 15 g in 1 TUBE (0168-0332-15) | $0.3551 / g | $5.33 | 2004-05-14 | Active |
| 00168-0332-30 | 30 g in 1 TUBE (0168-0332-30) | $0.2504 / g | $7.51 | 2004-05-14 | Active |
| 00168-0332-60 You're viewing this | 60 g in 1 TUBE (0168-0332-60) | $0.2255 / g | $13.53 | 2004-05-14 | Active |
You're viewing the largest of 3 pack sizes for this product.
This pack has the lowest per-g cost of the 3 priced pack sizes ($0.2255 NADAC).
This pack shows little to no recent Medicaid volume — the 15 gs pack carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 00168-0332-60?
What is the difference between NDC 00168-0332-60 and NDC 00168-0332-15?
What NDC number is used to bill for this package of FLUTICASONE PROPIONATE .5 mg/g Cream?
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.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established.
The safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Fluticasone propionate cream, 0.05% may be used in adult and pediatric patients 3 months of age or older. Safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients for more than 4 weeks of use have not been established (see PRECAUTIONS: Pediatric Use ). The safety and efficacy of Fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established.
Atopic Dermatitis Apply a thin film of fluticasone propionate cream, 0.05% to the affected skin areas once or twice daily. Rub in gently. Other Corticosteroid-Responsive Dermatoses Apply a thin film of fluticasone propionate cream, 0.05% to the affected skin areas twice daily.
Rub in gently. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Fluticasone propionate cream, 0.05% should not be used with occlusive dressings. Fluticasone propionate cream, 0.05% should not be applied in the diaper area: as diapers or plastic pants may constitute occlusive dressings. Geriatric Use In studies where geriatric patients (65 years of age or older, see PRECAUTIONS ) have been treated with fluticasone propionate cream, 0.05%, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
⛔ Contraindications ▾
CONTRAINDICATIONS Fluticasone propionate cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In controlled clinical trials of twice daily administration, the total incidence of adverse reactions associated with the use of fluticasone propionate cream, 0.05% was approximately 4%. These adverse reactions were usually mild, self-limiting; and consisted primarily of pruritus, dryness, numbness of fingers, and burning. These events occurred in 2.9%, 1.2%, 1.0%, and 0.6% of patients, respectively.
Two clinical studies compared once to twice-daily administration of fluticasone propionate cream, 0.05% for the treatment of moderate to severe eczema. The local drug-related adverse events for the 491 patients enrolled in both studies are shown in Table 1 . In the study enrolling both adult and pediatric patients, the incidence of local adverse events in the 119 pediatric patients ages 1 to 12 years was comparable to the 140 patients ages 13 to 62 years.
Fifty-one pediatric patients ages 3 months to 5 years, with moderate to severe eczema, were enrolled in an open-label HPA axis safety study. Fluticasone propionate cream, 0.05% was applied twice daily for 3 to 4 weeks over and arithmetic mean body surface area of 64% (range 35% to 95%). The mean morning cortisol levels with standard deviations before treatment (pre-stimulation mean value =13.76±6.94 mcg/dL, post-stimulation mean value =30.53±7.23 mcg/dL) and at end treatment (pre-stimulation mean value =12.32±6.92 mcg/dL, poststimulation mean value =28.84±7.16 mcg/dL) showed little change.
In 2 of 43 (4.7%) patients with end-treatment results, peak cortisol levels following cosyntropin stimulation testing were ≤18 mcg/dL indicating adrenal suppression. Follow-up testing after treatment discontinuation, available for 1 of the 2 subjects, demonstrated a normally responsive HPA axis. Local drug-related adverse events were (see Table 2 ): transient burning, resolving the same day it was reported; transient urticaria, resolving the same day it was reported; erythematous rash; dusky erythema, resolving within one month after cessation of fluticasone propionate cream, 0.05%; and telangiectasia resolving within 3 months after stopping fluticasone propionate cream, 0.05%.
Table 1: Drug-Related Adverse Events—Skin Adverse Events Fluticasone Once Daily (n=210) Fluticasone Twice Daily (n=203) Vehicle Twice Daily (n=78) Skin infection 1 (0.5%) 0 0 Infected eczema 1 (0.5%) 2 (1.0%) 0 Viral warts 0 1 (0.5%) 0 Herpes simplex 0 1 (0.5%) 0 Impetigo 1 (0.5%) 0 0 Atopic dermatitis 1 (0.5%) 0 0 Eczema 1 (0.5%) 0 0 Exacerbation of eczema 4 (1.9%) 1 (0.5%) 1 (1.3%) Erythema 0 2 (1.0%) 0 Burning 2 (1.0%) 2 (1.0%) 2 (2.6%) Stinging 0 2 (1.0%) 1 (1.3%) Skin irritation 6 (2.9%) 2 (1.0%) 0 Pruritus 2 (1.0%) 4 (1.9%) 4 (5.1%) Exacerbation of Pruritus 4 (1.9%) 1 (0.5%) 1 (1.3%) Folliculitis 1 (0.5%) 1 (0.5%) 0 Blisters 0 1 (0.5%) 0 Dryness of skin 3 (1.4%) 1 (0.5%) 0 Table 2: Adverse Events* from Pediatric Open-label Trial (n=51) *See text for additional detail. † n=41 Adverse Events Fluticasone Twice Daily Burning 1 (2.0%) Dusky Erythema 1 (2.0%) Erythematous Rash 1 (2.0%) Facial Telangiectasia † 2 (4.9%) Non Facial Telangiectasia 1 (2.0%) Urticaria 1 (2.0%) The following local adverse reactions have been reported infrequently with topical corticosteroids and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids.
These reactions are listed in an approximately decreasing order of occurrence: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, hypertrichosis and miliaria. Also, there are reports of the development of pustular psoriasis from chronic plaque psoriasis following reduction or discontinuation of potent topical corticosteroid products.
🤰 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.
Teratology studies in the mouse demonstrated fluticasone propionate to be teratogenic (cleft palate) when administered subcutaneously in doses of 45 mcg/kg per day and 150 mcg/kg per day. This dose is approximately 14 and 45 times, respectively, the human topical dose of fluticasone propionate cream, 0.05%. There are no adequate and well-controlled studies in pregnant women.
Fluticasone propionate cream, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use Fluticasone propionate cream, 0.05% may be used with caution in pediatric patients as young as 3 months of age. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established.
Fluticasone propionate cream, 0.05%, caused HPA axis suppression in 2 of 43 pediatric patients, ages 2 and 5 years old, who were treated for 4 weeks covering at least 35% of the body surface area. Follow-up testing 12 days after treatment discontinuation, available for 1 of the 2 subjects, demonstrated a normally responsive HPA axis (see ADVERSE REACTIONS ). Adverse effects including striae have been reported with use of topical corticosteroids in pediatric patients.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels to an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
🧓 Geriatric Use ▾
Geriatric Use A limited number of patients above 65 years of age (n=126) have been treated with fluticasone propionate cream in US and non-US clinical trials. While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of fluticasone propionate cream in geriatric patients warranted.
🆘 Overdosage ▾
OVERDOSAGE Topically applied fluticasone propionate cream, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Like other topical corticosteroids, fluticasone propionate 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 . Fluticasone propionate is lipophilic and has a strong affinity for the glucocorticoid receptor.
It has weak affinity for the progesterone receptor, and virtually no affinity for the mineralocorticoid, estrogen, or androgen receptors. The therapeutic potency of glucocorticoids is related to the half-life of the glucocorticoid-receptor complex. The half-life of the fluticasone propionate-glucocorticoid receptor complex is approximately 10 hours.
Studies performed with fluticasone propionate cream, 0.05% indicate that it is in the medium range of potency as compared with other topical corticosteroids. Pharmacokinetics: Absorption The activity of fluticasone propionate cream is due to the parent drug, fluticasone propionate. 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 human study of 12 healthy males receiving 12.5 g of 0.05% fluticasone propionate cream twice daily for 3 weeks, plasma levels were generally below the level of quantification (0.05 ng/mL). In another study of six healthy males administered 25 g of 0.05% fluticasone propionate cream under occlusion for 5 days, plasma levels of fluticasone ranged from 0.07 to 0.39 ng/mL. In an animal study using radiolabeled 0.05% fluticasone propionate cream and ointment preparations, rats received a topical dose of 1 g/kg for a 24 hour period.
Total recovery of radioactivity was approximately 80% at the end of 7 days. The majority of the dose (73%) was recovered from the surface of the application site. Less than 1% of the dose was recovered in the skin at the application site.
Approximately 5% of the dose was absorbed systemically through the skin. Absorption from the skin continued for the duration of the study (7 days), indicating a long retention time at the application site. Distribution Following intravenous administration of 1 mg fluticasone propionate in healthy volunteers, the initial disposition phase for fluticasone propionate was rapid and consistent with its high lipid solubility and tissue binding.
The apparent volume of distribution averaged
4.2L/kg (range 2.3-16.7 L/kg). 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 a human skin homogenate. The total blood clearance of systemically absorbed fluticasone propionate averages 1,093 mL/min (range 618-1,702 mL/min) after a 1 mg intravenous dose, with renal clearance accounting for less than 0.02% of the total.
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…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Fluticasone propionate cream USP, 0.05% is supplied in: 15 g tubes NDC 0168-0332-15 30 g tubes NDC 0168-0332-30 60 g tubes NDC 0168-0332-60 Store between 2° and 30° C (36° and 86° F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, NY 11747 46233142A R07/18 #91
📋 Description ▾
DESCRIPTION Fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP [(6α,11β,16α,17α)-6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid S -fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate is C 25 H 31 F 3 O 5 S.
It has the following structural formula: Fluticasone propionate USP 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 cream USP, 0.05% contains fluticasone propionate USP 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water and imidurea as preservative.
Structural Formula
💬 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. 2. This medication should not be used for any disorder other than that for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician. 4.
Patients should report to their physicians any signs of local adverse reactions. 5. Parents of pediatric patients should be advised not to use this medication in the treatment of diaper dermatitis.
Fluticasone propionate cream, 0.05% should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressing (see DOSAGE AND ADMINISTRATION ). 6. This medication should not be used on the face, underarms, or groin areas unless directed by a physician.
7. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.