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.

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Label (Diclofenac1.5 Sola 1038)

This is a description of a topical solution containing diclofenac sodium USP. Each mL of the solution contains 16.05 mg of diclofenac sodium along with various excipients. The product is intended for external use only. It comes in a 5 fl. oz. (150mL) container and should be dispensed with a Medication Guide to each patient. It is manufactured by SOLA Pharmaceuticals, LLC and repackaged by PHOENIX RX LLC in Hatboro, PA. The solution is labeled with NDC# 8550910381 and includes additional information for dosage, administration, and warnings related to skin irritation.*

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Eff 2 (Efficacy 2 Copy)

This text appears to be related to a study or evaluation involving the WOMAC pain score, WOMAC physical function, and PGA (Patient Global Assessment). It also mentions a psychosocial formulation and the inclusion of a certain percentage of DMSO. The context of the study or evaluation seems to be focused on assessing efficacy variables.*

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Efficacy (Efficacy Variable Copy)

The text provides information on a study that evaluated the efficacy of diclofenac sodium and topical placebo on efficacy variables after 12 weeks. It includes mean baseline scores for different efficacy variables and the comparison between diclofenac sodium, topical placebo, and topical vehicle. The study assessed WOMAC pain score, WOMAC physical function, and POMA. The placebo formulation included 23% DMSO, and the vehicle formulation included 45.5% DMSO.*

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Figure A (Figure A Copy)

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Figure B (Figure B C Copy)

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Molecule (Molecule Copy)

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Pharmacokinetic (Pharmacokinetic Parameters Copy)

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Treatment (Treatment Group Copy)

This is a list of adverse reactions associated with the topical application of Diclofenac Sodium Solution 15%. These reactions include dry skin, contact dermatitis, dyspepsin, abdominal pain, flatulence, pruritus, diarrhea, nausea, pharyngitis, edema, rash, ecchymosis, paresthesia, accidental injury, and halitosis. It is important to note that these reactions can occur both with and without application of the solution. The severity of the reactions varies, with some being more common and others less common.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.