Diclofenac Sodium 1.5% Solution
Product Images NDC 85509-1038

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Diclofenac Sodium 1.5% (NDC 85509-1038). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Phoenix Rx 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.

FDA Label Image

Label (Diclofenac1.5 Sola 1038)

Label for Diclofenac Sodium Topical Solution USP 1.5% w/w containing 16.05 mg/mL diclofenac sodium. The solution is 5 fl. oz. (150 mL), for external use only, and prescription use. Manufactured by SOLA Pharmaceuticals, LLC and repackaged by PHOENIX RX LLC, Hatboro, PA. Includes warnings about skin irritation and instructions for pharmacists to dispense the Medication Guide.*

FDA Label Image

Eff 2 (Efficacy 2 Copy)

A data table presenting efficacy variables comparing Diclofenac Sodium 1.5% Topical Solution versus a topical vehicle after 12 weeks of treatment. The variables include mean baseline scores and mean changes for WOMAC pain score, WOMAC physical function, and PGA, with sample sizes for each group (164 for Diclofenac solution, 162 for topical vehicle). The vehicle formulation included 45.5% DMSO.*

FDA Label Image

Efficacy (Efficacy Variable Copy)

A data table presenting efficacy variable results from Study I comparing Diclofenac Sodium Topical Solution with topical placebo and topical vehicle after 12 weeks. The table includes mean baseline scores and mean changes in WOMAC pain and physical function scores, along with POHA values, showing comparative effects across the three treatment groups.*

FDA Label Image

Figure A (Figure A Copy)

An instructional illustration depicting two methods of applying a topical solution. The left image shows a hand dispensing the solution onto an open palm, while the right image shows the hand directly applying solution to a bent elbow or knee area.*

FDA Label Image

Figure B (Figure B C Copy)

Instructional diagram showing the application of a topical solution. Figure B depicts a hand applying the solution to the knee area using downward hand motions. Figure C illustrates application to the lower leg with a circular hand motion.*

FDA Label Image

Molecule (Molecule Copy)

Chemical structure of Diclofenac Sodium, showing the sodium salt of the compound with two chlorine atoms on the aromatic ring and a carboxylate group.*

FDA Label Image

Pharmacokinetic (Pharmacokinetic Parameters Copy)

A data table presenting pharmacokinetic parameters of diclofenac sodium in normal adults aged 18 to 55 years, comparing values after a single dose versus multiple doses (four times daily for seven days). Parameters include AUC, plasma Cmax, Tmax, half-life, elimination rate constant, and clearance.*

FDA Label Image

Treatment (Treatment Group Copy)

A data table comparing the incidence of adverse reactions in study groups using Diclofenac Sodium Topical Solution 1.5% w/w and a topical placebo. It lists various adverse reactions with corresponding counts and percentages for each treatment group, showing frequency of reactions at application and non-application sites among other effects.*

* 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.