fluticasone propionate .5 mg/mL Lotion, 60 mL — NDC 45802-441-02 (Billing 45802-0441-02)
This is a package of 60 mL of fluticasone propionate .5 mg/mL Lotion from Padagis Israel Pharmaceuticals Ltd, marketed since Aug 2013 and currently FDA-listed; retail pharmacies pay about $2.96 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 45802-441-02 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 45802 labeler · 441 product · 02 package
- Package marketed since
- Aug 8, 2013
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 60 mL per package
- Barcode (UPC-A, from the NDC)
- 3 4580244102 7
- Medicaid fills, this package
- 60 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): 059177
- GCN: 24717
- GPI-14 (Medi-Span): 90550068104120
- HICL (First Databank): 007873
- AHFS class code: 84:06.08.00
- RxCUI (RxNorm): 895990
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
- 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $2.963 | $177.80 / 60 ml |
| Medicaid paysCMS SDUD · 12 mo | $2.58 | $154.73 / 60 ml |
| Medicare drug plans payPart D · Q2 2026 | $4.03 | $241.77 / 60 ml |
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 | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 45802-0441-02 You're viewing this Main listing | 60 mL in 1 BOTTLE | 2013-08-08 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| fluticasone propionate .5 mg/mLthis 45802-0441-02 | Padagis | 60 ml | $2.963 | — | Availability likely | — |
| Fluticasone Propionate .5 mg/mL 68462-0427-02 | Glenmark | 1 bottle | $3.867 | — | FDA listed | +31% |
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 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 92RU3N3Y1O
Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
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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 A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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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 Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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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.
12 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
- dextromethorphan polistirex extended release 30 mg/5mL Suspension NDC 45802-433-21
- clotrimazole 1 g/100g Cream NDC 45802-434-01
- TAZAROTENE .5 mg/g Gel NDC 45802-436-01
- Clobetasol Propionate .5 mg/g Aerosol, Foam NDC 45802-437-32
- hydrocortisone 1 g/100g Cream NDC 45802-438-03
- Penciclovir 10 mg/g Cream NDC 45802-440-75
- TAZAROTENE 1 mg/g Gel NDC 45802-442-01
- ESTRADIOL 1 mg/g Gel NDC 45802-452-30
- Adapalene .1 g/100g Cream NDC 45802-453-84
- Ketoconazole 20 mg/mL Shampoo, Suspension NDC 45802-465-64
- Econazole Nitrate 10 mg/g Cream NDC 45802-466-11
- Hydrocortisone Acetate Pramoxine Hcl 2.5 g/100g; 1 g/100g Cream NDC 45802-472-53
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 lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 months of age or older. Fluticasone propionate lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 months of age and older. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Apply a thin film of fluticasone propionate lotion to the affected skin areas once daily. Rub in gently. Discontinue use when control is achieved.
If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. The safety and efficacy of fluticasone propionate lotion have not been established beyond 4 weeks of use. Avoid use with occlusive dressings or application to the diaper area [ see Warnings and Precautions ( 5.1 ) and ( 5.2 ) ].
Fluticasone propionate lotion is for topical use only, and not for ophthalmic, oral, or intravaginal use. • Apply a thin film to the affected skin areas once daily. Rub in gently. ( 2 ) • Discontinue use when control is achieved.
( 2 ) • Reassess diagnosis if no improvement in 2 weeks. ( 2 ) • The safety and efficacy of fluticasone propionate lotion have not been established beyond four weeks of use. ( 2 ) • Avoid use under occlusion or application to diaper area.
( 2 ) • Not for ophthalmic, oral, or intravaginal use. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Lotion, 0.05%. Each gram of fluticasone propionate lotion USP contains 0.5 mg fluticasone propionate USP in a white to off-white lotion base. Fluticasone propionate lotion USP is supplied in 60 mL bottles. • Lotion, 0.05%, supplied in 60 mL bottles. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. • None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression: Reversible HPA axis suppression and resulting glucocorticoid insufficiency can occur during or after withdrawal of treatment. Risk factors include the use of high-potency topical corticosteroids, use over large surface area, prolonged use, use under occlusion, concomitant use with other corticosteroid-containing products, altered skin barrier, liver failure, and use in pediatric patients. Minimize risk by mitigating the risk factors and use product as recommended.
Modify use if HPA axis suppression is suspected. ( 5.1 , 8.4 ) • Skin Irritation and Sensitization: fluticasone propionate lotion contains the excipient imidurea which releases formaldehyde as a breakdown product. Formaldehyde may cause allergic sensitization or irritation upon contact with the skin.
Discontinue use if irritation or sensitization develops. ( 5.2 )
5.1Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects Topical corticosteroids, including fluticasone propionate lotion can produce reversible HPA axis suppression with the potential for glucocorticoid insufficiency. Risk factors that predispose to HPA axis suppression include the use of high-potency topical corticosteroids, large treatment surface areas, prolonged use, use under occlusion, concomitant use of more than one corticosteroid-containing product, altered skin barrier, and liver failure.
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 ) ]. 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 a less potent topical corticosteroid.
Evaluation of HPA axis suppression may be done by using the cosyntropin stimulation test. The effects of fluticasone propionate lotion on HPA axis function in pediatric patients were investigated in two trials. Among a total of 89 evaluable subjects from the two trials who were treated with fluticasone propionate lotion twice daily for 3 to 4 weeks, a single subject with >90% body surface area treated showed laboratory evidence of transient suppression immediately post-treatment.
The post cosyntropin stimulation test serum cortisol returned to a normal level (22.1 μg/dL) within one week of the final treatment visit [ see Use In Specific Populations ( 8.4 ) and Clinical Pharmacology ( 12.2 ) ]. Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic absorption of topical corticosteroids.
5.2Local Adverse Reactions Fluticasone propionate lotion may cause local adverse reactions, including skin atrophy [ see Adverse Reactions ( 6.1 , 6.2 ) ]. The risk is greater with use under occlusion and with higher potency products. Fluticasone propionate lotion contains the excipient imidurea which releases formaldehyde as a breakdown product.
Formaldehyde may cause allergic sensitization or irritation upon contact with the skin. Avoid using fluticasone propionate lotion in individuals with hypersensitivity to formaldehyde as it may prevent healing or worsen dermatitis. If irritation develops, discontinue fluticasone propionate lotion and institute appropriate therapy.
Allergic Contact Dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation. Such an observation can be corroborated with appropriate diagnostic patch testing. Discontinue fluticasone propionate lotion if appropriate.
5.3Concomitant Skin Infections If skin infections are present or develop at the treatment site, an appropriate antimicrobial agent should be used. If… [Excerpted — this section continues on DailyMed.]
🤒 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 ( 5.3 ) ] The most common adverse reactions (2%) were burning/stinging at the application site. ( 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: Controlled Clinical Trials 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 2 multicenter vehicle-controlled clinical trials of once-daily application of fluticasone propionate lotion by 196 adult and 242 pediatric patients, the total incidence of adverse reactions considered drug related by investigators was approximately 4%.
These were local cutaneous reactions, usually mild and self-limiting, and consisted primarily of burning/stinging (2%). All other drug-related events occurred with an incidence of less than 1%, and included were contact dermatitis, exacerbation of atopic dermatitis, folliculitis of legs, pruritus, pustules on arm, rash, and skin infection. See Table 1.
The incidence of adverse reactions between the 242 pediatric subjects (age 3 months to < 17 years) and 196 adult subjects (17 years or older) was similar (4% and 5%, respectively). Table 1: Adverse Reactions from Controlled Clinical Trials (N=438) Adverse Reactions Fluticasone propionate lotion n=221 Vehicle n=217 Burning/Stinging skin 4 (2%) 3 (1%) Contact Dermatitis 0 1 (<1%) Exacerbation of Atopic dermatitis 0 1 (<1%) Folliculitis of legs 2 (<1%) 0 Irritant Contact Dermatitis 0 1 (<1%) Pruritus 1 (<1%) 1 (<1%) Pustules on Arms 1 (<1%) 0 Rash 1 (<1%) 2 (<1%) Skin Infection 0 3 (1%) During the clinical trials, eczema herpeticum occurred in a 33-year old male patient treated with fluticasone propionate lotion.
Table 2 summarizes all adverse events by body system that occurred in at least 1% of patients in either the drug or vehicle group in the phase 3 controlled clinical trials. Table 2: Adverse Events Occurring in ≥1% of Patients from Either Arm from Controlled Clinical Trials (n=438) Body System Fluticasone propionate lotion (N=221) Vehicle Lotion (N=217) Any Adverse Event 77 (35%) 82 (38%) Skin Burning and Stinging 4 (2%) 3 (1%) Pruritus 3 (1%) 5 (2%) Rash 2 (<1%) 3 (1%) Skin Infection 0 3 (1%) Ear, Nose, Throat Common Cold 9 (4%) 5 (2%) Ear Infection 3 (1%) 3 (1%) Nasal Sinus Infection 2 (<1%) 4 (2%) Rhinitis 1 (<1%) 3 (1%) Upper Respiratory Tract Infection 6 (3%) 7 (3%) Gastrointestinal Normal Tooth Eruption 2 (<1%) 3 (1%) Diarrhea 3 (1%) 0 Vomiting 3 (1%) 2 (<1%) Lower Respiratory Cough 7 (3%) 6 (3%) Influenza 5 (2%) 0 Wheeze 0 3 (1%) Neurology Headache 4 (2%) 5 (2%) Non-Site Specific Fever 8 (4%) 8 (4%) Seasonal Allergy 2 (<1%) 3 (1%)
6.2Clinical Trials Experience: Pediatric Open Label Trials In an open label HPA axis suppression trial of 44 pediatric subjects (ages ≥3 months to ≤6 years) fluticasone propionate lotion was applied twice daily (rather than the indicated dosing regimen of once daily) to at least 35% of body surface area for 3 or 4 weeks. Subjects whose lesions cleared after 2 or 3 weeks of treatment continued to apply fluticasone propionate lotion for an additional week. The overall incidence of adverse reactions was 14%.
These were local, cutaneous reactions and included dry skin (7%), stinging at application site (5%), and excoriation (2%). Additionally, a 4-month-old patient treated with fluticasone propionate lotion had marked elevations of the hepatic enzymes AST and ALT. [ see Use in Specific Populations ( 8.4 ) ] In… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Therefore, fluticasone propionate lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic embryofetal development studies were conducted in mice, rats and rabbits.
Subcutaneous doses of 15, 45 and 150 μg/kg/day of fluticasone propionate were administered to pregnant female mice from gestation days 6 to 15. A teratogenic effect characteristic of corticosteroids (cleft palate) was noted after administration of 45 and 150 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) in this study. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 15 μg/kg/day (less than the MRHD in adults based on body surface area comparisons).
Subcutaneous doses of 10, 30 and 100 μg/kg/day of fluticasone propionate were administered to pregnant female rats in two embryofetal development studies (one study administered fluticasone propionate from gestation days 6 to 15 and the other study from gestation days 7 to 17). In the presence of maternal toxicity, fetal effects noted at 100 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) included decreased fetal weights, omphalocele, cleft palate, and retarded skeletal ossification. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 10 μg/kg/day (less than the MRHD in adults based on body surface area comparisons).
Subcutaneous doses of 0.08, 0.57 and 4 μg/kg/day of fluticasone propionate were administered to pregnant female rabbits from gestation days 6 to 18. Fetal effects noted at 4 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) included decreased fetal weights, cleft palate and retarded skeletal ossification. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 0.57 μg/kg/day (less than the MRHD in adults based on body surface area comparisons).
Oral doses of 3, 30 and 300 μg/kg/day fluticasone propionate were administered to pregnant female rabbits from gestation days 8 to 20. No fetal or teratogenic effects were noted at oral doses up to 300 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) in this study. However, no fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration.
Fluticasone propionate crossed the placenta following administration of a subcutaneous or an oral dose of 100 μg/kg tritiated fluticasone propionate to pregnant rats.
8.3Nursing Mothers Systemically administered corticosteroids appear in human milk and can 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 fluticasone propionate lotion is administered to a nursing woman.
8.4Pediatric Use Fluticasone propionate lotion may be used in pediatric patients as young as 3 months of age. The safety and effectiveness of fluticasone propionate lotion in pediatric patients below 3 months of age have not been established. 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 an HPA axis suppression trial, none of the 40 evaluable pediatric subjects, 4 months old to < 6 years old, with moderate to severe atopic dermatitis covering ≥ 35% Body Surface Area (BSA) who were treate… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Therefore, fluticasone propionate lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic embryofetal development studies were conducted in mice, rats and rabbits.
Subcutaneous doses of 15, 45 and 150 μg/kg/day of fluticasone propionate were administered to pregnant female mice from gestation days 6 to 15. A teratogenic effect characteristic of corticosteroids (cleft palate) was noted after administration of 45 and 150 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) in this study. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 15 μg/kg/day (less than the MRHD in adults based on body surface area comparisons).
Subcutaneous doses of 10, 30 and 100 μg/kg/day of fluticasone propionate were administered to pregnant female rats in two embryofetal development studies (one study administered fluticasone propionate from gestation days 6 to 15 and the other study from gestation days 7 to 17). In the presence of maternal toxicity, fetal effects noted at 100 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) included decreased fetal weights, omphalocele, cleft palate, and retarded skeletal ossification. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 10 μg/kg/day (less than the MRHD in adults based on body surface area comparisons).
Subcutaneous doses of 0.08, 0.57 and 4 μg/kg/day of fluticasone propionate were administered to pregnant female rabbits from gestation days 6 to 18. Fetal effects noted at 4 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) included decreased fetal weights, cleft palate and retarded skeletal ossification. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 0.57 μg/kg/day (less than the MRHD in adults based on body surface area comparisons).
Oral doses of 3, 30 and 300 μg/kg/day fluticasone propionate were administered to pregnant female rabbits from gestation days 8 to 20. No fetal or teratogenic effects were noted at oral doses up to 300 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) in this study. However, no fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration.
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 Fluticasone propionate lotion may be used in pediatric patients as young as 3 months of age. The safety and effectiveness of fluticasone propionate lotion in pediatric patients below 3 months of age have not been established. 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 an HPA axis suppression trial, none of the 40 evaluable pediatric subjects, 4 months old to < 6 years old, with moderate to severe atopic dermatitis covering ≥ 35% Body Surface Area (BSA) who were treated with an exaggerated dosing regimen (twice daily) of fluticasone propionate lotion experienced adrenal suppression (defined as a 30-minute post-stimulation cortisol level ≤18 micrograms/dL) [ see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.2 ) ].
In another HPA axis suppression trial, one of 49 (2%) evaluable pediatric subjects, 3 months to 11 months old, with moderate to severe atopic dermatitis covering ≥ 35% Body Surface Area (BSA) who applied an exaggerated dosing regimen (twice daily) of fluticasone propionate lotion experienced reversible adrenal suppression (defined as a 30-minute post-stimulation cortisol level ≤18 micrograms/dL) following 4 weeks of therapy [ see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.2 ) ] . Systemic effects such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high-potency topical corticosteroids, or concomitant use of more than one corticosteroid product.
Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients. Parents of pediatric patients should be advised not to use this medication in the treatment of diaper dermatitis unless directed by a physician. Fluticasone propionate lotion should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressing.
🧓 Geriatric Use ▾
8.5Geriatric Use A limited number of patients above 65 years of age have been treated with fluticasone propionate lotion in US and non-US clinical trials. Specifically only 8 patients above 65 years of age were treated with fluticasone propionate lotion in controlled clinical trials. The number of patients is too small to permit separate analyses of efficacy and safety.
🧬 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 lotion in atopic dermatitis is unknown.
12.2Pharmacodynamics Vasoconstrictor Assay Trials performed with fluticasone propionate lotion 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. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression In an open label HPA axis suppression trial (Trial A), 42 pediatric subjects (ages 4 months to <6 years) with moderate to severe atopic dermatitis covering ≥ 35% Body Surface Area (BSA) who were treated with an exaggerated dosing regimen of fluticasone propionate lotion twice daily (rather than the indicated dosing regimen of once daily) for at least 3 to 4 weeks were assessed for HPA axis suppression.
The mean BSA treated was 65%. None of the 40 evaluable subjects were suppressed. The criterion for HPA axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter at 30-minutes after cosyntropin stimulation.
Another open label HPA axis suppression trial (Trial B) enrolled 56 pediatric subjects (ages 3 months to 11 months) with moderate to severe atopic dermatitis covering ≥ 35% BSA. Subjects were treated with an exaggerated dosing regimen of fluticasone propionate lotion twice daily over a period of 3 or 4 weeks. The mean BSA treated was 54%.
Out of 56 subjects, 49 were considered evaluable with respect to their adrenal axis function post-treatment. One of 49 subjects showed laboratory evidence of suppression immediately post treatment. The criterion for HPA axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter at 30-minutes after cosyntropin stimulation.
Repeated test one week later showed the post cosyntropin stimulation testing serum cortisol returned to normal level (22.1 μg/dL). This 4-month old subject had a baseline treatment BSA of 94% and was reported to have received 100% of the twice-daily applications of fluticasone propionate lotion, 0.05% over the 27 day treatment period.
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. Plasma fluticasone levels were measured in a subset of subjects 2 to 5 years and 11 months of age in HPA axis suppression trial (Trial A) described above. A total of 13 (62%) of 21 subjects tested had measurable fluticasone at the end of 3 to 4 weeks of treatment.
The mean ± SD fluticasone plasma concentration was 0.16 ± 0.23 ng/mL. Three subjects aged 3, 4, and 4 years had fluticasone concentrations over 0.30 ng/mL, with one of them having a concentration of 0.82 ng/mL. No data were obtained for subjects < 2 years of age.
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 a human skin homogenate. Fluticasone propionate is metabolized in the liver by cytochrome P450 3A4-mediated hydrolysis of the 5-fluoromethyl carbothiolate grouping. This transformation occurs in 1 metabolic step to produce the inactive 17β-carboxylic acid metabolite, the only known metabolite detected in man.
This metabolite has approximately 200… [Excerpted — this section continues on DailyMed.]
🧬 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 lotion in atopic dermatitis is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Fluticasone Propionate Lotion USP, 0.05% is white to off-white in color, and supplied as follows: 60 mL bottle NDC 45802- 441 -02 Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Do not refrigerate, and keep container tightly closed.
📋 Description ▾
11 DESCRIPTION Fluticasone propionate lotion USP, 0.05% 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. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate, USP 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 practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Each gram of fluticasone propionate lotion USP contains 0.5 mg fluticasone propionate USP in a white to off white lotion base of anhydrous citric acid, cetomacrogol 1000, cetostearyl alcohol, dimethicone 360, imidurea, isopropyl myristate, methylparaben, mineral oil, propylene glycol, propylparaben, purified water, and sodium citrate.
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💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Administration Instructions Advise the patient of appropriate fluticasone propionate lotion administration instructions, including those that will mitigate HPA-Axis suppression [ see Warnings and Precautions (5.1) ] and local adverse reactions [ see Warnings and Precautions ( 5.2 ) ]: • Discontinue therapy when control is achieved in less than 4 weeks; if no improvement is seen within 2 weeks, contact the healthcare provider. • 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. • Do not use fluticasone propionate lotion in the treatment of diaper dermatitis unless directed by the healthcare provider, as diapers or plastic pants may constitute occlusive dressing and enhance absorption. • Do not use on the face, underarms, or groin areas unless directed by the healthcare provider.
Local Adverse Reactions Advise the patient to report any signs of local adverse reactions to their healthcare provider [ see Warnings and Precautions ( 5.2 ) ]. • Advise patients to report to their healthcare provider if they are allergic to formaldehyde. Manufactured by Padagis ® Yeruham, Israel www.padagis.com Rev 05-24 8K800 RC PH6
🧬 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. Plasma fluticasone levels were measured in a subset of subjects 2 to 5 years and 11 months of age in HPA axis suppression trial (Trial A) described above. A total of 13 (62%) of 21 subjects tested had measurable fluticasone at the end of 3 to 4 weeks of treatment.
The mean ± SD fluticasone plasma concentration was 0.16 ± 0.23 ng/mL. Three subjects aged 3, 4, and 4 years had fluticasone concentrations over 0.30 ng/mL, with one of them having a concentration of 0.82 ng/mL. No data were obtained for subjects < 2 years of age.
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 a human skin homogenate. Fluticasone propionate is metabolized in the liver by cytochrome P450 3A4-mediated hydrolysis of the 5-fluoromethyl carbothiolate grouping. This transformation occurs in 1 metabolic step to produce the inactive 17β-carboxylic acid metabolite, the only known metabolite detected in man.
This metabolite has approximately 2000 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 Trials performed with fluticasone propionate lotion 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. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression In an open label HPA axis suppression trial (Trial A), 42 pediatric subjects (ages 4 months to <6 years) with moderate to severe atopic dermatitis covering ≥ 35% Body Surface Area (BSA) who were treated with an exaggerated dosing regimen of fluticasone propionate lotion twice daily (rather than the indicated dosing regimen of once daily) for at least 3 to 4 weeks were assessed for HPA axis suppression.
The mean BSA treated was 65%. None of the 40 evaluable subjects were suppressed. The criterion for HPA axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter at 30-minutes after cosyntropin stimulation.
Another open label HPA axis suppression trial (Trial B) enrolled 56 pediatric subjects (ages 3 months to 11 months) with moderate to severe atopic dermatitis covering ≥ 35% BSA. Subjects were treated with an exaggerated dosing regimen of fluticasone propionate lotion twice daily over a period of 3 or 4 weeks. The mean BSA treated was 54%.
Out of 56 subjects, 49 were considered evaluable with respect to their adrenal axis function post-treatment. One of 49 subjects showed laboratory evidence of suppression immediately post treatment. The criterion for HPA axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter at 30-minutes after cosyntropin stimulation.
Repeated test one week later showed the post cosyntropin stimulation testing serum cortisol returned to normal level (22.1 μg/dL). This 4-month old subject had a baseline treatment BSA of 94% and was reported to have received 100% of the twice-daily applications of fluticasone propionate lotion, 0.05% over the 27 day treatment period.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Fluticasone propionate lotion applied once daily was superior to vehicle in the treatment of atopic dermatitis in two clinical trials. The two trials enrolled 438 subjects with atopic dermatitis aged 3 months and older, of which 169 subjects were selected as having clinically significant signs of erythema, infiltration/papulation, and erosion/oozing/crusting at baseline. Clinically significant was defined as having moderate or severe involvement for at least two of the three signs (erythema, infiltrations/papulation, or erosion/oozing/crusting), in at least 2 body regions.
Subjects who had moderate to severe disease in a single body region were excluded from the analysis. Table 3 presents the percentage of subjects who completely cleared of erythema, infiltration/papulation and erosion/oozing/crusting at Week 4 out of those subjects with clinically significant baseline signs. Table 3: Complete Clearance Rate For Patients with Clinically Significant Signs at Baseline Fluticasone propionate lotion Vehicle Study 1 9/45 (20%) 0/37 (0%) Study 2 7/44 (16%) 1/43 (2%)
🧪 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 (less than the MRHD in adults based on body surface area comparisons) 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 (less than the MRHD in adults based on body surface area comparisons) in this study. Fluticasone propionate revealed no evidence of mutagenic or clastogenic potential based on the results of 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).
No evidence of impairment of fertility or effect on mating performance was observed in a fertility and general reproductive performance study conducted in male and female rats at subcutaneous doses up to 50 μg/kg/day (less than the MRHD in adults based on body surface area comparisons).
📄 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 (less than the MRHD in adults based on body surface area comparisons) 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 (less than the MRHD in adults based on body surface area comparisons) in this study. Fluticasone propionate revealed no evidence of mutagenic or clastogenic potential based on the results of 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).
No evidence of impairment of fertility or effect on mating performance was observed in a fertility and general reproductive performance study conducted in male and female rats at subcutaneous doses up to 50 μg/kg/day (less than the MRHD in adults based on body surface area comparisons).
📄 Patient Package Insert ▾
PATIENT INFORMATION Fluticasone Propionate (floo-TIK-a-sone PROE-pee-oh-nate)Lotion USP, 0.05% Important: Fluticasone propionate lotion is for use on skin only (topical). Do not get fluticasone propionate lotion near or in your eyes, mouth, or vagina. Read this Patient Information before you start using fluticasone propionate lotion 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 treatment. What is fluticasone propionate lotion?
Fluticasone propionate lotion is a prescription corticosteroid medicine used on the skin (topical) for the relief of inflammation and itching caused by certain skin conditions, including atopic dermatitis and eczema in people 3 months of age and older. It is not known if fluticasone propionate lotion is safe and effective in children under 3 months of age. Before using fluticasone propionate lotion, tell your healthcare provider about all of your medical conditions, including if you: • 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 • are allergic to formaldehyde. If you are allergic to formaldehyde, fluticasone propionate lotion may cause skin irritation, prevent your skin from healing or worsen your skin condition. • are pregnant or plan to become pregnant. It is not known if fluticasone propionate lotion will harm your unborn baby. • are breastfeeding or plan to breastfeed.
It is not known if fluticasone propionate can pass into your breast milk and harm 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 lotion? • Use fluticasone propionate lotion exactly as your healthcare provider tells you to use it. • Apply a thin film of fluticasone propionate lotion to the affected area 1 time 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 apply fluticasone propionate lotion to dermatitis in the diaper area unless your healthcare provider tells you to. • Wash your hands after applying fluticasone propionate lotion, unless your hands are being treated. • Tell your healthcare provider if your symptoms get worse with fluticasone propionate lotion or if your symptoms do not improve after 2 weeks of treatment.
It is not known if fluticasone propionate lotion is safe or effective when used more than 4 weeks. What are possible side effects with fluticasone propionate lotion? Fluticasone propionate lotion may cause serious side effects, including: • Fluticasone propionate lotion can pass through your skin and may cause adrenal gland problems.
This is more likely to happen if you use fluticasone propionate lotion 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 lotion. • 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, tenderness, swelling, or healing problems. The most common side effects of fluticasone propionate lotion include burning and stinging at the treatment site. These are not all the possible side effects with fluticasone propionate lotion.
Call your doctor for medical advic… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 45802-441-02 Rx Only Fluticasone Propionate Lotion USP, 0.05% For Topical Use Only Not For Ophthalmic, Oral or Intravaginal Use. 60 mL 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. label serialization-example