Diclofenac Sodium 30 mg/g Gel, 100 g
Other active recalls for Diclofenac Sodium (different manufacturers) — 3 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- An actinic keratosis — often just called an AK — is a rough, scaly patch on the skin caused by years of sun exposure. These patches are considered precancerous, meaning they could...
- What exactly is an actinic keratosis, and why do I need a prescription gel for it?
- The typical treatment course runs 60 to 90 days of twice-daily application — that's a solid commitment, but it's necessary for the gel to do its job. Here's the thing: even after y...
- How long do I need to use this gel, and how will I know it's working?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Diclofenac Sodium — tap one for details:
Diclofenac Sodium may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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UNII ZF94AP8MEY
Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
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UNII X70SE62ZAR
Hydroxyethyl cellulose is a plant-derived thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a thickener for gels or liquids, and sometimes as a coating agent.
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UNII ENK4Y6S66X
A synthetic liquid polymer derived from petroleum that acts as a solvent and humectant. It helps dissolve active ingredients, improves product flow, and prevents moisture loss in liquid and semi-solid medicines.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.5711 | $57.11 / 100 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Diclofenac Sodium 30 mg/g 00472-1783-10 | Actavis | 1 tube | $0.370 | AB | Availability likely | — |
| diclofenac sodium 30 mg/g 45802-0111-01 | Padagis | 1 tube | $0.370 | AB | Availability likely | — |
| Diclofenac Sodium 30 mg/g 62332-0581-31 | Alembic | 1 tube | $0.370 | AB | Availability likely | — |
| Diclofenac Sodium 30 mg/g 68462-0355-94 | GLENMARK | 1 tube | $0.370 | AB | Availability likely | — |
| Diclofenac Sodium 30 mg/g 00115-1483-56 | Amneal | 1 tube | — | — | Discontinued | — |
| Diclofenac Sodium 30 mg/g 45865-0260-01 | Medsource | 100 g | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 46708-0581-31 | Alembic | 1 tube | — | AB | FDA listed | — |
| Diclofenac sodium 30 mg/g 51672-1363-03 | Sun | 1 tube | — | AB | FDA listed | — |
| diclofenac sodium 30 mg/g 63629-2526-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 68071-3516-01 | NuCare | 1 tube | — | AB | FDA listed | — |
| Diclofenac sodium 30 mg/g 68071-3688-01 | NuCare | 1 tube | — | AB | FDA listed | — |
| diclofenac sodium 30 mg/g 68071-4859-01 | NuCare | 100 g | — | AB | FDA listed | — |
| Diclofenac sodium 30 mg/g 68788-8236-01 | Preferred | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 68788-8456-01 | Preferred | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 68788-9435-01 | Preferred | 1 tube | — | AB | FDA listed | — |
| diclofenac sodium 30 mg/g 70518-2526-00 | REMEDYREPACK | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 70518-3315-00 | REMEDYREPACK | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 70518-3779-00 | REMEDYREPACK | 1 tube | — | AB | FDA listed | — |
| Diclofenac sodium 30 mg/g 71205-0538-00 | Proficient | 1 tube | — | AB | FDA listed | — |
| diclofenac sodium 30 mg/g 71205-0692-00 | Proficient | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 71205-0752-00 | Proficient | 1 tube | — | AB | FDA listed | — |
| diclofenac sodium 30 mg/g 72162-1391-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 72189-0040-01 | Direct_Rx | 1 g | — | AB | FDA listed | — |
| Diclofenac Sodium Gel 30 mg/g 72189-0379-01 | Direct_Rx | 1 g | — | AB | FDA listed | — |
| Diclofenac Sodium Gel 30 mg/g 72189-0473-01 | Direct_Rx | 1 g | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/gthis 76420-0025-01 | Asclemed | 100 g | — | — | FDA listed | — |
| Diclofenac Sodium 30 mg/g 76420-0132-01 | Asclemed | 100 g | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 76420-0261-01 | Asclemed | 1 tube | — | AB | FDA listed | — |
| Diclofenac sodium 30 mg/g 76420-0275-01 | Asclemed | 100 g | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 80425-0234-01 | Advanced | 1 tube | — | — | FDA listed | — |
| Diclofenac Sodium 30 mg/g 80425-0235-01 | Advanced | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 80425-0236-01 | Advanced | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 80425-0338-01 | Advanced | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 82804-0052-00 | Proficient | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 82804-0250-00 | Proficient | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 85509-1581-01 | PHOENIX | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 87063-0165-01 | ASCLEMED | 1 tube | — | AB | FDA listed | — |
| Diclofenac sodium 30 mg/g 68788-4118-01 | Preferred | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 85534-0089-00 | HAWAII | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 76420-0025-01 You're viewing this | 100 g in 1 TUBE (76420-025-01) | 2020-06-17 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: RISK OF SERIOUS CARDIOVASCULAR EVENTS Cardiovascular Thrombotic Events - Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. - Diclofenac Sodium Gel, 3% is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Diclofenac Sodium Gel, 3% is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Diclofenac Sodium Gel, 3% is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site.
Assure that enough Diclofenac Sodium Gel, 3% is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. The recommended duration of therapy is from 60 days to 90 days.
Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. Lesions that do not respond to therapy should be carefully re-evaluated and management reconsidered.
⛔ Contraindications ▾
CONTRAINDICATIONS Diclofenac Sodium Gel, 3% is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol and/or polyethylene glycol monomethyl ether 350. Diclofenac Sodium Gel, 3% is contraindicated in the following patients: - In the setting of coronary artery bypass graft (CABG) surgery.
⚠️ Warnings ▾
WARNINGS As with other NSAIDs, anaphylactoid reactions may occur in patients without prior exposure to diclofenac. Diclofenac sodium should be given with caution to patients with the aspirin triad. The triad typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs.
Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.
However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious gastrointestinal (GI) events. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10–14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.
NSAIDs are contraindicated in the setting of CABG. Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients.
Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up. Avoid the use of diclofenac sodium gel, 3% in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If diclofenac sodium gel, 3% is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
Heart Failure and Edema The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death. Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs.
Use of diclofenac may blunt the CV effects of several therapeutic agents used to treat these medical conditions [e.g., diureti…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Of the 423 patients evaluable for safety in adequate and well-controlled trials, 211 were treated with diclofenac sodium gel, 3% drug product and 212 were treated with a vehicle gel. Eighty-seven percent (87%) of the diclofenac sodium gel, 3%-treated patients (183 patients) and 84% of the vehicle-treated patients (178 patients) experienced one or more adverse events (AEs) during the studies. The majority of these reactions were mild to moderate in severity and resolved upon discontinuation of therapy.
Of the 211 patients treated with diclofenac sodium gel, 3%, 172 (82%) experienced AEs involving skin and the application site compared to 160 (75%) vehicle-treated patients. Application site reactions (ASRs) were the most frequent AEs in both diclofenac sodium gel, 3%-and vehicle-treated groups. Of note, four reactions, contact dermatitis, rash, dry skin and exfoliation (scaling) were significantly more prevalent in the diclofenac sodium gel, 3% group than in the vehicle-treated patients.
Eighteen percent of diclofenac sodium gel, 3%-treated patients and 4% of vehicle-treated patients discontinued from the clinical trials due to adverse events (whether considered related to treatment or not). These discontinuations were mainly due to skin irritation or related cutaneous adverse reactions. Table 1 below presents the AEs reported at an incidence of >1% for patients treated with either diclofenac sodium gel, 3% or vehicle (60- and 90-day treatment groups) during the phase 3 studies.
Table 1. Adverse Events Reported (>1% in Any Treatment Group) During Diclofenac Sodium Gel, 3% Phase 3 Clinical Trials Incidences for 60-Day and 90-Day Treatments 60-day Treatment 90-day Treatment Diclofenac Sodium Gel, 3% (%) N=48 Gel Vehicle (%) N=49 Diclofenac Sodium Gel, 3% (%) N=114 Gel Vehicle (%) N=114 BODY AS A WHOLE 21 20 20 18 Abdominal Pain 2 0 1 0 Accidental Injury 0 0 4 2 Allergic Reaction 0 0 1 3 Asthenia 0 0 2 0 Back Pain 4 0 2 2 Chest Pain 2 0 1 0 Chills 0 2 0 0 Flu Syndrome 10 6 1 4 Headache 0 6 7 6 Infection 4 6 4 5 Neck Pain 0 0 2 0 Pain 2 0 2 2 CARDIOVASCULAR SYSTEM 2 4 3 1 Hypertension 2 0 1 0 Migraine 0 2 1 0 Phlebitis 0 2 0 0 DIGESTIVE SYSTEM 4 0 6 8 Constipation 0 0 0 2 Diarrhea 2 0 2 3 Dyspepsia 2 0 3 4 METABOLICS AND NUTRITIONAL DISORDERS 2 8 7 2 Creatine Phosphokinase Increased 0 0 4 1 Creatinine Increased 2 2 0 1 Edema 0 2 0 0 Hypercholesteremia 0 2 1 0 Hyperglycemia 0 2 1 0 SGOT Increased 0 0 3 0 SGPT Increased 0 0 2 0 MUSCULOSKELETAL SYSTEM 4 0 3 4 Arthralgia 2 0 0 2 Arthrosis 2 0 0 0 Myalgia 2 0 3 1 NERVOUS SYSTEM 2 2 2 5 Anxiety 0 2 0 1 Dizziness 0 0 0 4 Hypokinesia 2 0 0 0 RESPIRATORY SYSTEM 8 8 7 6 Asthma 2 0 0 0 Dyspnea 2 0 2 0 Pharyngitis 2 8 2 4 Pneumonia 2 0 0 1 Rhinitis 2 2 2 2 Sinusitis 0 0 2 0 SKIN AND APPENDAGES 75 86 86 71 Acne 0 2 0 1 Application Site Reaction 75 71 84 70 Acne 0 4 1 0 Alopecia 2 0 1 1 Contact Dermatitis 19 4 33 4 Dry Skin 27 12 25 17 Edema 4 0 3 0 Exfoliation 6 4 24 13 Hyperesthesia 0 0 3 1 Pain 15 22 26 30 Paresthesia 8 4 20 20 Photosensitivity Reaction 0 2 3 0 Pruritus 31 59 52 45 Rash 35 20 46 17 Vesiculobullous Rash 0 0 4 1 Contact Dermatitis 2 0 0 0 Dry Skin 0 4 3 0 Herpes Simplex 0 2 0 0 Maculopapular Rash 0 2 0 0 Pain 2 2 1 0 Pruritus 4 6 4 1 Rash 2 10 4 0 Skin Carcinoma 0 6 2 2 Skin Nodule 0 2 0 0 Skin Ulcer 2 0 1 0 SPECIAL SENSES 2 0 4 2 Conjunctivitis 2 0 4 1 Eye Pain 0 2 2 0 UROGENITAL SYSTEM 0 0 4 5 Hematuria 0 0 2 1 OTHER 0 0 0 3 Procedure 0 0 0 3 Skin and Appendages Adverse Events Reported for diclofenac sodium gel, 3% at Less Than 1% Incidence in the Phase 3 Studies: skin hypertrophy, paresthesia, seborrhea, urticaria, application site reactions (skin carcinoma, hypertonia, skin hypertrophy lacrimation disorder, maculopapular rash, purpuric rash, vasodilation).
Adverse Reactions Reported for Oral Diclofenac Dosage Form (not topical diclofenac sodium gel, 3%): *Incidence Greater than 1% marked with asterisk. Body as a Whole: abdominal pain or cramps*, headache*,…
🆘 Overdosage ▾
OVERDOSAGE Due to the low systemic absorption of topically-applied diclofenac sodium gel, 3%, overdosage is unlikely. There have been no reports of ingestion of diclofenac sodium gel, 3%. In the event of oral ingestion, resulting in significant systemic side effects, it is recommended that the stomach be emptied by vomiting or lavage.
Forced diuresis may theoretically be beneficial because the drug is excreted in the urine. The effect of dialysis or hemoperfusion in the elimination of diclofenac (99% protein-bound) remains unproven. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption of diclofenac.
Supportive and symptomatic treatment should be given for complications such as renal failure, convulsions, gastrointestinal irritation and respiratory depression.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The mechanism of action of diclofenac sodium in the treatment of actinic keratoses (AK) is unknown. The contribution to efficacy of individual components of the vehicle has not been established. Pharmacokinetics Absorption When diclofenac sodium gel, 3% is applied topically, diclofenac is absorbed into the epidermis.
In a study in patients with compromised skin (mainly atopic dermatitis and other dermatitic conditions) of the hands, arms or face, approximately 10% of the applied dose (2 grams of 3% gel over 100 cm 2 ) of diclofenac was absorbed systemically in both normal and compromised epidermis after seven days, with four times daily applications. After topical application of 2 g diclofenac sodium gel, 3% three times daily for six days to the calf of the leg in healthy subjects, diclofenac could be detected in plasma. Mean bioavailability parameters were AUC0-t 9±19 ng/hr/mL (mean±SD) with a C max of 4±5 ng/mL and a T max of 4.5±8 hours.
In comparison, a single oral 75 mg dose of diclofenac (Voltaren ® ) † produced an AUC of 1600 ng/hr/mL. Therefore, the systemic bioavailability after topical application of diclofenac sodium gel, 3% is lower than after oral dosing. Comparative bioavailability studies have not been conducted between available diclofenac topical products (gels containing 1 to 3% diclofenac) which have different dosing regimens.
A cross-study evaluation of the data indicates that diclofenac is more bioavailable when applied to diseased skin and less bioavailable when applied to intact skin. Blood drawn at the end of treatment from 60 patients with AK lesions treated with diclofenac sodium gel, 3% in three adequate and well-controlled clinical trials was assayed for diclofenac levels. Each patient was administered 0.5 g of diclofenac sodium gel, 3% twice a day for up to 105 days.
There were up to three 5 cm X 5 cm treatment sites per patient on the face, forehead, hands, forearm, and scalp. Serum concentrations of diclofenac were, on average, at or below 20 ng/mL. These data indicate that systemic absorption of diclofenac in patients treated topically with diclofenac sodium gel, 3% is much lower than that occurring after oral daily dosing of diclofenac sodium.
No information is available on the absorption of diclofenac when diclofenac sodium gel, 3% is used under occlusion. Distribution Diclofenac binds tightly to serum albumin. The volume of distribution of diclofenac following oral administration is approximately 550 mL/kg.
Metabolism Biotransformation of diclofenac following oral administration involves conjugation at the carboxyl group of the side chain or single or multiple hydroxylations resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates. Two of these phenolic metabolites are biologically active, however to a much smaller extent than diclofenac. Metabolism of diclofenac following topical administration is thought to be similar to that after oral administration.
The small amounts of diclofenac and its metabolites appearing in the plasma following topical administration makes the quantification of specific metabolites imprecise. Elimination Diclofenac and its metabolites are excreted mainly in the urine after oral dosing. Systemic clearance of diclofenac from plasma is 263±56 mL/min (mean±SD).
The terminal plasma half-life is 1 to 2 hours. Four of the metabolites also have short terminal half-lives of 1 to 3 hours.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Available in tubes of 100 g. Each gram of gel contains 30 mg of diclofenac sodium. 100 g tube – NDC 76420-025-01 (relabeled from NDC 0115-1483-61) Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from heat. Avoid freezing. † Voltaren ® is a registered trademark of Novartis. Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501
📋 Description ▾
DESCRIPTION Diclofenac Sodium Gel, 3%, contains the active ingredient, diclofenac sodium, in a clear, transparent, colorless to slightly yellow gel base. Diclofenac sodium is a white to slightly yellow crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water, slightly soluble in acetone, and partially insoluble in ether.
The chemical name for diclofenac sodium is: Sodium [o-(2,6-dichloranilino) phenyl] acetate Diclofenac sodium has a molecular weight of 318.13. The CAS number is CAS-15307-79-6. The structural formula is represented below: Diclofenac Sodium Gel, 3% also contains benzyl alcohol, hydroxyethyl cellulose, methoxypolyethylene glycol 350, PEG-60 hydrogenated castor oil, and purified water.
1 g of Diclofenac Sodium Gel, 3% contains 30 mg of the active substance, diclofenac sodium. 352da3e2-figure-01
💬 Medication Guide ▾
Medication Guide Diclofenac (dye kloe’ fen ak) Sodium Gel, 3% What is the most important information I should know about Diclofenac Sodium Gel, 3% and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? Diclofenac Sodium Gel, 3% is an NSAID medicine that is used on the skin only (topical). Do not use Diclofenac Sodium Gel, 3% in or on the eyes.
NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take or use NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG)". Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to.
You may have an increased risk of another heart attack if you take or use NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What is Diclofenac Sodium Gel, 3%?
Diclofenac Sodium Gel, 3% is an NSAID that is used on the skin (topical) to treat a skin condition called actinic keratosis. Diclofenac Sodium Gel, 3% is not for use in children. Who should not use Diclofenac Sodium Gel, 3%?
Do not use Diclofenac Sodium Gel, 3%: if you have had an allergic reaction to any of the ingredients in Diclofenac Sodium Gel, 3%. See the end of this Medication Guide for a complete list of ingredients in Diclofenac Sodium Gel, 3%. right before or after heart bypass surgery. Before using Diclofenac Sodium Gel, 3%, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems have high blood pressure have asthma are pregnant or plan to become pregnant.
Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take or use NSAIDs after 29 weeks of pregnancy. are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will use Diclofenac Sodium Gel, 3% or breastfeed.
You should not do both. Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects.
Do not start taking any new medicine without talking to your healthcare provider first. How should I use Diclofenac Sodium Gel, 3%? Use Diclofenac Sodium Gel, 3% exactly as your healthcare provider tells you to use it.
Apply Diclofenac Sodium Gel, 3% 2 times a day. Apply enough Diclofenac Sodium Gel, 3% to cover each skin lesion and gently rub in. Diclofenac Sodium Gel, 3% may be used for 60 to 90 days.
You may not see improvement of skin lesions for up to 30 days after stopping treatment. See your healthcare provider if lesions do not respond to treatment. Wash your hands after applying Diclofenac Sodium Gel, 3%.
What should I avoid while using Diclofenac Sodium Gel, 3%? Avoid spending time in sunlight or artificial light, such as tanning beds or sunlamps. Diclofenac Sodium Gel, 3% can make your skin sensitive to sunlight and the light from tanning beds and sunlamps.
You should avoid applying Diclofenac Sodium Gel, 3% to open skin wounds, skin infections, or peeling skin. What are the possible side effects of Diclofenac Sodium Gel, 3%? Dic…