Gynazole 1 Cream
Product Images NDC 45802-396

7 FDA label images from Padagis Israel Pharmaceuticals Ltd · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gynazole 1 (NDC 45802-396). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Padagis Israel Pharmaceuticals Ltd, 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

Chemical Structure.jpg (Image 01)

Chemical  Structure.jpg (Image 01)
Chemical structure diagram of butoconazole nitrate, the active ingredient in Gynazole 1 cream 100 mg/5g, showing its molecular components including chlorine atoms and a thiazole ring.*
FDA Label Image

Table 1.jpg (Image 02)

Table 1.jpg (Image 02)
A table comparing clinical study results between 2% butoconazole nitrate cream and 500-mg clotrimazole vaginal tablet. It presents enrollment numbers, late follow-up evaluable patients, clinical cure rates, mycologic eradication rates, and therapeutic cure rates for both treatments, including a note on Candida albicans presence in vaginal cultures at admission.*
FDA Label Image

Figure 1 And 2.jpg (Image 03)

Figure 1 And 2.jpg (Image 03)
An instructional diagram illustrating two views of a vaginal applicator for gynazole 1 cream, highlighting parts labeled as ring, plunger, applicator, and tip.*
FDA Label Image

Figure 3a Figure 3b.jpg (Image 04)

Figure 3a Figure 3b.jpg (Image 04)
Instructional illustrations showing two methods of administration for a vaginal product. Figure 3A depicts patient-administered insertion using a device, while Figure 3B depicts professionally administered insertion with a finger. Both are black and white line drawings focusing on hand positioning and application technique.*
FDA Label Image

Figure 4a Figure 4b Figure 4c.jpg (Image 05)

Figure 4a Figure 4b Figure 4c.jpg (Image 05)
Illustration showing different methods of administering gynazole 1 cream vaginally. Figures 4A and 4B depict patient-administered insertion techniques, while Figure 4C shows professional administration using an applicator.*
FDA Label Image

Carton (Carton)

Carton (Carton)
Gynazole-1 Butoconazole Nitrate Vaginal Cream USP, 2%, in a 5.8 g prefilled disposable applicator. The packaging highlights 100 mg butoconazole nitrate in 5 g cream and indicates vaginal use only. Labeler is Padagis Israel Pharmaceuticals Ltd, NDC 45802-396-01.*
FDA Label Image

Serialization (Image 06)

Serialization (Image 06)
A text panel intended for track and trace information, displaying placeholders for the product's serial number (S/N), lot number, and expiration date (Exp) to be inserted. The panel is bordered by a black rectangular outline with black text on a white background.*

* 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.