Diclofenac Sodium 1.5%
Product Images NDC 50436-3338

8 FDA label images from Unit Dose Services · 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 1.5% (NDC 50436-3338). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Unit Dose Services, 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

Eff 2 (Efficacy 2 Copy)

Eff 2 (Efficacy 2 Copy)
A data table comparing efficacy variables after 12 weeks of treatment between Diclofenac Sodium Topical Solution (N=164) and a topical vehicle (N=162). Variables include WOMAC pain score, WOMAC physical function, and PGA scores with mean baseline scores and mean changes reported. The vehicle formulation includes 45.5% DMSO.*
FDA Label Image

Efficacy (Efficacy Variable Copy)

Efficacy (Efficacy Variable Copy)
A data table presenting Study I results comparing mean baseline scores and mean changes in efficacy variables after 12 weeks of treatment with Diclofenac Sodium Topical Solution, topical placebo, and topical vehicle. Variables include WOMAC pain score, WOMAC physical function, and POHA scores with respective numerical values.*
FDA Label Image

Figure A (Figure A Copy)

Figure A (Figure A Copy)
An instructional illustration labeled Figure A showing two hand positions for applying a product. The left image displays a hand holding a small bottle above an open palm, while the right image shows a hand holding the bottle positioned above an arm, demonstrating alternative application methods.*
FDA Label Image

Figure B (Figure B C Copy)

Figure B (Figure B C Copy)
Illustrations labeled Figure B and Figure C showing hand placement instructions for applying a product to the knee area. Figure B depicts a hand pulling down on a strip or patch on the knee, while Figure C shows a hand pressing or smoothing the product onto the knee.*
FDA Label Image

Molecule (Molecule Copy)

Molecule (Molecule Copy)
Chemical structure of Diclofenac Sodium. The structure shows two aromatic rings connected via an amine (NH) group, with two chlorine atoms attached to one ring and a carboxylate sodium salt (COONa) group attached to the other.*
FDA Label Image

Pharmacokinetic (Pharmacokinetic Parameters Copy)

Pharmacokinetic (Pharmacokinetic Parameters Copy)
A data table presenting pharmacokinetic parameters of Diclofenac Sodium in normal adults aged 18 to 55 years. It compares values for single dose and multiple dose (four times daily for 7 days) including AUC0-t, AUC0-inf, plasma Cmax, plasma Tmax, plasma t1/2, Kel, and CL/F.*
FDA Label Image

Treatment (Treatment Group Copy)

Treatment (Treatment Group Copy)
A data table presenting the frequency of adverse reactions in two groups: Diclofenac Sodium Topical Solution 1.5% w/w (N=911) and Topical Placebo (N=332). It details adverse reactions such as dry skin, contact dermatitis, dyspepsia, abdominal pain, and others, with the number and percentage of subjects affected in each group.*
FDA Label Image

Label Image (Lbl504363338)

Label Image (Lbl504363338)
Diclofenac Sodium 1.5% topical solution, 150 mL bottle label from Unit Dose Services. The label includes active ingredient information, storage instructions, manufacturer details (Sola Pharmaceuticals, Baton Rouge, LA), and indicates the product is for external use only with a prescription.*

* 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.