Diclox Patch 30CT

Diclox Patch 30CT is an FDA-registered drug product whose active ingredient is DICLOFENAC EPOLAMINE 1.3% PATCH. It is labelled by Injecta Medcial LLC taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 87234-0405, application NDA021234, label effective 20260522. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DICLOFENAC EPOLAMINE 1.3% PATCH are most often described in connection with: usage diclofenac, epolamine topical, system indicated, treatment acute, pain due, minor strains, contusions adults, pediatric patients. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.

2 DOSAGE AND ADMINISTRATION 2.1 General Dosing Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5)]. The recommended dose of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is one (1) topical system to the most painful area twice a day both in adults and pediatric patients 6 years of age and older. 2.2 Special Precautions Inform patients that, if DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% begins to peel-off, the edges of the topical system may be taped down. If problems with adhesion persist, patients may overlay the topical system with a mesh netting sleeve, where appropriate (e.g. to secure topical systems applied to ankles, knees, or elbows). The mesh netting sleeve (e.g. Curad® Hold Tite™, Surgilast® Tubular Elastic Dressing) must allow air to pass through and not be occlusive (non-breathable). Do not apply DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% to non-intact or damaged skin resulting from any etiology e.g. exudative dermatitis, eczema, infected lesion, burns or wounds. Do not wear a DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% when bathing or showering. Wash your hands after applying, handling or removing the topical system. Avoid eye contact. Do not use combination therapy with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.

4 CONTRAINDICATIONS DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [ see Warnings and Precautions (5.7, 5.9) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions (5.7, 5.8) ] In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions (5.1)] DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is contraindicated for use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds.

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [ see Warnings and Precautions (5.1)] GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions (5.2)] Hepatotoxicity [ see Warnings and Precautions (5.3)] Hypertension [ see Warnings and Precautions (5.4)] Heart Failure and Edema [ see Warnings and Precautions (5.5)] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions (5.6)] Anaphylactic Reactions [ see Warnings and Precautions (5.7)] Serious Skin Reactions [ see Warnings and Precautions (5.9)] Hematologic Toxicity [ see Warnings and Precautions (5.12)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Clinical Trials Experience In controlled trials during the premarketing development of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%, approximately 600 patients with minor sprains, strains, and contusions were treated with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% for up to two weeks. Adverse Events Leading to Discontinuation of Treatment In the controlled trials, 3% of patients in both the DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and placebo groups discontinued treatment due to an adverse event. The most common adverse events leading to discontinuation were application site reactions, occurring in 2% of both the DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and placebo groups. Application site reactions leading to dropout included pruritus, dermatitis, and burning. Common Adverse Events Overall, the most common adverse events associated with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% treatment were skin reactions at the site of treatment. Table 1 lists all adverse events, regardless of causality, occurring in ≥ 1% of patients in controlled trials of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%. A majority of patients treated with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% had adverse events with a maximum intensity of "mild" or "moderate." Foreign labeling describes that dermal allergic reactions may occur with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% treatment. Additionally, the treated area may become irritated or develop itching, erythema, edema, vesicles, or abnormal sensation. Pediatric Clinical Trials Experience In one open-label trial, 104 male and female pediatric patients 6 years and older presenting with minor strains, sprains, and contusions received DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3 % twice a day for as many as 16 days. The most commonly reported adverse events (incidence ≥ 2%) were headache (9%), application site pruritus (7%), nausea (3%), and dyspepsia (3%). No adverse events led to discontinuation of treatment. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of diclofenac. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and Appendages: Exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and fixed drug eruption (FDE). adverse reactions

What is Diclox Patch 30CT used for?
1 INDICATIONS AND USAGE DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.

Who makes Diclox Patch 30CT?
Injecta Medcial LLC is the labeler of record for Diclox Patch 30CT.

What form does Diclox Patch 30CT come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Diclox Patch 30CT prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Diclox Patch 30CT been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.