Fluticasone Propionate Cream
Product Images NDC 0713-0631

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Fluticasone Propionate (NDC 0713-0631). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Cosette Pharmaceuticals, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

15g Carton

15g Carton
Fluticasone Propionate cream is for dermatologic use only and should not be used for ophthalmic purposes. It contains Fluticasone propionate 0.05% in a cream base that includes propylene glycol, mineral oil, stostearyl aloohol, Ceteth-20, isopropyl myistate, ibasic sodium phosphate, citic acid, purified water, and methylparaben as a preservative. The suggested dosage is to apply a thin film of cream twice a day to affected skin areas. The cream is stored at 20-25°C (68-77°F) [s6e USP Controlled Room Temperatures]. The product is distributed by Cosats Pharmaceuticas, Inc. and includes a metal tamper-resistant seal that should not be punctured. A punctured or invisible seal means the product should not be used and should be returned to the place of purchase. See the package insert for complete prescribing information.*
FDA Label Image

15g Tube

15g Tube
This is a cream medication for dermatologic use only and not for ophthalmic use that contains 0.05% Fluticasone propionate in a cream base of various ingredients. The normal dosage requires a thin application twice daily on the affected skin areas. It is necessary to check the package insert for complete prescribing information. The cream should be stored within the range of 20-25°C (68-77°F) [see USP Controlled Room Temperature]. It is recommended not to use the product if the seal is either punctured or not visible. The product is distributed by Cosette Pharmaceuticals, Inc., located at South Plainfield, NJ 07080.*
FDA Label Image

30g Carton

30g Carton
Fluticasone Propionate cream is used for dermatologic purposes only and is not for ophthalmic use. The usual dosage is to apply a thin film of the cream twice daily to affected skin areas. The cream contains 0.05% Fluticasone propionate in a cream base of propylene glycol, mineral oil, cetostearyl alcohol, Geteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water, and methylparaben as a preservative. The product should be stored at 20-25°C (68-7T°F) and should not be used if the tamper-resistant seal is punctured or not visible. The cream is distributed by Gosette Pharmaceuticals, Inc. and further information can be found on the packaging insert.*
FDA Label Image

30g Tube

30g Tube
Fluticasone Propionate Cream, USP is a medication for dermatologic use only, containing 0.05% Fluticasone propionate in a cream base. The cream consists of several ingredients, including propylene glycol, mineral oil, cetostearyl alcohol, isopropyl myristate, and others. It's recommended to apply twice daily for affected skin areas. The medication is distributed by Cosette Pharmaceuticals, Inc., and stored at 20-25°C (68-77°F). The package insert should be consulted for complete prescribing information. If the seal is punctured or not visible, do not use the cream. The cap must be used to puncture the seal. Lot number and expiration date are shown on the crimp.*
FDA Label Image

60g Carton

60g Carton
Fluticasone Propionate Cream is a medication for dermatologic use only and should not be used for ophthalmic purposes. It is recommended to apply a small amount of cream to the affected skin twice a day. The cream must be stored between 20-25°C (68-77°F) and must be kept away from the reach of children. The cream contains Fluticasone Propionate 0.05% as the active ingredient along with other ingredients including Propylene Glycol, Mineral Oil, and Citric Acid. This product has a tamper-resistant seal that must not be used if it is punctured or not visible. To use, reverse the cap and puncture the seal using the puncture-top of the cap. Note that this description pertains only to the readable text, and any non-English characters or symbols may change the meaning of the text or indicate a different product.*
FDA Label Image

60g Tube

60g Tube
Fluticasone Propionate is a cream used for dermatologic purposes only, containing 0.05% of Fluticasone Propionate in a cream base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water, and methylparaben as a preservative. The usual dosage is to apply a thin film of cream twice daily to the affected skin areas. It is important not to use if the seal has been punctured, and the cream should be stored at 20-25°C (68-77°F) with the lot number and expiration date visible on the crimp. Full prescribing information can be found in the package insert. It is not for ophthalmic use. It is distributed by Cosette Pharmaceuticals, Inc. in South Plainfield, NJ.*
FDA Label Image

Structured Formula (Formula)

FDA Label Image

Table1 (Table1)

Table1 (Table1)
This is a table displaying the drug-related adverse events in the skin caused by Fluticasone. The adverse events are listed in rows, and the frequency of each event is listed in columns based on the dosage frequency. The events include skin infections, infected eczema, viral warts, herpes simplex, impetigo, atopic dermatitis, eczema, exacerbation of eczema, erythema, burning, stinging, skin irritation, pruritus, exacerbation of pruritus, folliculitis, blisters, and dryness of skin. The frequency of each event is presented as percentages, with m and n representing the number of individuals experiencing each event within the corresponding dosage frequency column.*
FDA Label Image

Table2 (Table2)

Table2 (Table2)
This is a table of adverse events experienced in a pediatric open-label trial of Fluticasone administered twice daily. The table includes the frequency of events such as burning, dusky erythema, erythematous rash, facial telangiectasial, non-facial telangiectasia, and urticaria. More details can be found in the accompanying text.*
FDA Label Image

Table3 (Table3)

Table3 (Table3)
This is a table that shows the physician's assessment of clinical response using Fluticasone Propionate Cream Vehicle in two different studies. The table displays the percentage of participants who had cleared, excellent, good, fair, poor, or worse responses in both studies with varying sample sizes.*
FDA Label Image

Table4 (Table4)

Table4 (Table4)
The text provides a table showing clinical signs and mean improvements over baseline for Fluticasone Propionate Cream versus the vehicle in four different studies. It reports data on erythema, thickening, and scaling with numerical values for each study.*
FDA Label Image

Table5 (Table5)

Table5 (Table5)
Table 5 shows the results of two studies on the clinical response to Fluticasone Propionate Cream, administered once daily and twice daily respectively. The table includes the percentage of patients who were assessed by physicians to have cleared, excellent, good, fair, poor, or worse results in each study.*
FDA Label Image

Table6 (Table6)

Table6 (Table6)
Table 6 shows the mean improvements over baseline for clinical signs and symptoms resulting from the use of Fluticasone Propionate cream both once and twice per day. It includes data from Study 1 and Study 2 for each dosing frequency. The clinical signs and symptoms measured include erythema, pruritus, thickening, lichenification, vesiculation, and crusting.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.