Diclofenac Sodium Solution
Product Images NDC 80425-0240

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Diclofenac Sodium (NDC 80425-0240). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Advanced Rx Of Tennessee, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

Product Images & Figures Index

FDA Label Image

Description (Description)

Description (Description)
Chemical structure of Diclofenac Sodium, showing its molecular components including two chlorine atoms and a sodium carboxylate group attached to aromatic rings.*
FDA Label Image

Label1 (Diclofenac Sodium Solution 80425 0240 01)

Label1 (Diclofenac Sodium Solution 80425 0240 01)
Diclofenac Sodium 1.5% solution topical 150 mL bottle label. The label shows the strength as 16.05 mg/mL, compares product to Pennsaid with NDC 80425-0240-01, and lists the labeler as Advanced Rx of Tennessee, LLC. Storage temperatures of 20-25°C (68-77°F) are indicated, with an expiration date of 1/31/2024.*
FDA Label Image

Fig A (Fig 1)

Fig A (Fig 1)
An instructional illustration showing the application of a topical solution to different areas of the body: one hand applying the solution to the wrist and the other to the leg. The drawings depict hand positions for administering the solution to skin surfaces.*
FDA Label Image

Figure B And C (Fig B)

Figure B And C (Fig B)
Illustrative diagrams labeled Figure B and Figure C demonstrate application techniques for a topical solution. Figure B shows a hand applying the solution with downward arrows indicating the direction on the shoulder area. Figure C depicts a hand applying the solution to the knee region.*
FDA Label Image

Table 2 (Table 2)

Table 2 (Table 2)
A table presenting pharmacokinetic parameters of Diclofenac Sodium in normal adults aged 18 to 55 years. It compares values such as AUC, plasma concentration, half-life, and clearance for single and multiple doses of the drug.*
FDA Label Image

Table 1 (Table 1)

Table 1 (Table 1)
A data table comparing adverse reactions in patients using Diclofenac Sodium Topical Solution 1.5% w/w and a topical placebo. It lists various side effects with their corresponding number and percentage of occurrences for each treatment group.*
FDA Label Image

Tabve 3 (Table 3)

Tabve 3 (Table 3)
A data table titled 'Study I' showing mean baseline scores and mean changes in efficacy variables after 12 weeks of treatment. Variables include WOMAC pain score, WOMAC physical function, and POHA scores comparing Diclofenac Sodium Topical Solution, topical placebo, and topical vehicle groups with sample sizes provided.*
FDA Label Image

Table 4 (Table 4)

Table 4 (Table 4)
A data table comparing efficacy variables from Study II after 12 weeks of treatment with Diclofenac Sodium Topical Solution versus a topical vehicle in 164 and 162 subjects respectively. It shows mean baseline scores and mean changes in WOMAC pain score, WOMAC physical function, and PGA score, with the vehicle formulation containing 45.5% DMSO.*

* 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.