Fluticasone Propionate Cream
Product Images NDC 0713-0631

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

Fluticasone Propionate Cream USP 0.05% topical cream carton label from Cosette Pharmaceuticals, Inc. The 15 g package is labeled for dermatologic use only, excluding ophthalmic use, with a tamper-evident seal and storage instructions. The label includes dosage instructions, ingredients, barcodes, and NDC 0713-0631-15.*

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15g Tube

Fluticasone Propionate cream USP 0.05% topical cream in a 15 g container. The label specifies it is for dermatologic use only, not for ophthalmic use. Distributed by Cosette Pharmaceuticals, Inc. The label includes storage information, usage instructions, ingredient list, and a barcode with NDC 0713-0631-15.*

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30g Carton

Fluticasone Propionate Cream 0.05% topical cream carton label from Cosette Pharmaceuticals, Inc. The package size is 30 g. The label states it is for dermatologic use only and not for ophthalmic use. The NDC number 0713-0631-31 and Rx only designation are visible. The label includes storage and usage instructions, barcode, and information about the tamper-resistant seal.*

FDA Label Image

30g Tube

Fluticasone Propionate Cream USP 0.05% in a 30 g tube, labeled for dermatologic use only and not for ophthalmic use. The label includes instructions for use, storage conditions, and manufacturer information, identifying distribution by Cosette Pharmaceuticals, Inc. The NDC code 0713-0631-31 is displayed with a barcode.*

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60g Carton

Packaging label for Fluticasone Propionate Cream, USP 0.05%, topical cream in a 60 g size. The label indicates it is for dermatologic use only and not for ophthalmic use. Distributed by Cosette Pharmaceuticals, Inc., South Plainfield, NJ. Includes usage and storage instructions, ingredients, tamper-seal information, and a barcode with NDC 0713-0631.*

FDA Label Image

60g Tube

Fluticasone Propionate Cream USP 0.05% topical cream label with a net weight of 60 g. The label displays the product name, strength, dosage form, and indicates dermatologic use only. It includes storage instructions, distributor information for Cosette Pharmaceuticals, Inc., and a barcode with NDC 0713-0631-60.*

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Structured Formula (Formula)

Chemical structure diagram of Fluticasone Propionate, the active ingredient in the topical cream formulation by Cosette Pharmaceuticals, Inc.*

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Table1 (Table1)

A data table titled 'Drug-Related Adverse Events — Skin' comparing the frequency of various skin-related adverse events among three groups: Fluticasone Propionate once daily (210 subjects), Fluticasone Propionate twice daily (203 subjects), and vehicle twice daily (78 subjects). The table lists events such as skin infection, infected eczema, viral warts, herpes simplex, impetigo, atopic dermatitis, eczema, erythema, burning, itching, skin irritation, pruritis, folliculitis, blisters, and dryness of skin with corresponding occurrence counts and percentages for each treatment group.*

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Table2 (Table2)

A data table titled 'Adverse Events From Pediatric Open-Label Trial (n = 51)' listing adverse events and their occurrence rates with Fluticasone Propionate twice daily. Events listed include burning, dusky erythema, erythematous rash, facial telangiectasia, non-facial telangiectasia, and urticaria, with percentages ranging from 2.0% to 4.9%.*

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Table3 (Table3)

A data table titled "Physician's Assessment of Clinical Response" comparing outcomes between Fluticasone Propionate Cream and a vehicle control across two studies. It categorizes clinical response into six levels from Cleared to Worse, showing the percentage of patients in each category for Study 1 and Study 2 under both treatment groups.*

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Table4 (Table4)

Data table titled 'Clinical Signs: Mean Improvements Over Baseline' comparing Fluticasone Propionate Cream and Vehicle across two studies. It lists mean improvement values for erythema, thickening, and scaling for each group and study.*

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Table5 (Table5)

A data table titled "Table 5: Physician's Assessment of Clinical Response" presenting clinical response percentages for Fluticasone Propionate Cream applied once daily and twice daily, across two studies each. Response categories include Cleared, Excellent, Good, Fair, Poor, and Worse, with varying percentage results for each study and dosing frequency.*

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Table6 (Table6)

Table 6 presenting mean improvements over baseline for clinical signs and symptoms such as erythema, pruritis, thickening, lichenification, vesiculation, and crusting, comparing once daily and twice daily application of Fluticasone Propionate Cream in two different studies.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.