Diclona Gel

Direct_rx
Human Prescription Drug
NDC 72189-390

Diclona Gel is a human prescription drug labeled by 'Direct_rx'. National Drug Code (NDC) number for Diclona Gel is 72189-390. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Diclona Gel drug includes Diclofenac Sodium - .01 g/g Lidocaine - .045 g/g . The currest status of Diclona Gel drug is Active.

Drug Information:

Drug NDC:	72189-390
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Diclona Gel
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Diclona Gel
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Direct_rx
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	DICLOFENAC SODIUM - .01 g/g LIDOCAINE - .045 g/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	09 Nov, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	27 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Direct_Rx
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
NUI:	N0000175682 M0000897 N0000175426 N0000175976
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	QTG126297Q 98PI200987
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Amide Local Anesthetic [EPC] Antiarrhythmic [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Local Anesthesia [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Amides [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Amide Local Anesthetic [EPC] Amides [CS] Anti-Inflammatory Agents Non-Steroidal [CS] Antiarrhythmic [EPC] Cyclooxygenase Inhibitors [MoA] Decreased Prostaglandin Production [PE] Local Anesthesia [PE] Nonsteroidal Anti-inflammatory Drug [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
72189-390-35	35 g in 1 TUBE (72189-390-35)	09 Nov, 2022	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Diclona Gel

Gel
Direct_Rx
NDC: 72189-390

Product Elements:

Diclona gel diclona gel lidocaine lidocaine diclofenac sodium diclofenac aloe vera leaf eucalyptus oil almond oil dimethyl sulfoxide dimethyl sulfone ethylhexylglycerin sorbitol indian frankincense carbomer homopolymer, unspecified type phenoxyethanol trolamine arnica montana flower water alcohol

Indications and Usage:

Diclona gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. it should be applied only to intact skin. sun avoidance is indicated during therapy.

Warnings:

Medicines intended to be applied to the skin should not be swallowed. diclona gel is flammable. keep away from open flame. you should never heat, microwave, or add the medicine to hot water. risk of methemoglobinemia cases of methemoglobinemia have been reported in association with lidocaine use. although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing the condition. if lidocaine must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood. methemoglobin levels may continue to rise; therefor Read more...

e, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. 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. fetal toxicity avoid use of nsaids in pregnant women at about 30 weeks gestation and later. nsaids increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age. use of nsaids at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some case, neonatal renal impairment. if nsaid treatment is necessary between about 20 weeks and 30 weeks gestation, limit diclona gel use to the lowest effective dose and shortest duration possible. serious skin reactions drug rash with eosinophilia and systemic symptoms (dress) drug reaction with eosinophilia and systemic symptoms (dress) has been reported in patients taking nsaids such as diclona gel. dress typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. heart failure and edema the coxib and traditional nsaid trialistsâ 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. avoid the use of diclona gel in patients with severe heart failure unless benefits are expected to outweigh the risk of worsening heart failure. if diclona gel is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

Dosage and Administration:

Apply diclona gel to intact skin to cover the most painful area. clean and dry the affected area. apply product directly to your skin, up to 4 times daily. clothing may be worn over the area of application. if irritation or a burning sensation occurs during application, wash the product off your skin and do not reapply until the irritation subsides. when diclona gel is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

Contraindications:

Diclona gel is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product. diclona gel is contraindicated in patients with a known hypersensitivity to diclofenac sodium. diclona gel is contraindicated in patients in the setting of coronary artery bypass graft (cabg) surgery.

Adverse Reactions:

Application site reactions during or immediately after treatment with diclona gel, the skin at the site of application may develop blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. these reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. other adverse events due to the nature and limitation of spontaneous reports in post marketing surveillance, causality has not been established for additional reported adverse events including: asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor. systemic (dose-related) reactions systemic adverse reactions following appro Read more...

priate use of diclona gel are unlikely, due to the small dose absorbed (see clinical pharmacology, pharmacokinetics). systemic adverse effects of lidocaine is similar in nature to those observed with other amide local anesthetic agents, including cns excitation and/or depression (light headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). excitatory cns reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.

Overdosage:

Lidocaine overdose from cutaneous absorption is rare but could occur. excessive dosing by applying diclona gel to larger areas could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects (see adverse reactions, systemic reactions). longer duration of application of more than the recommended number of doses, smaller patients, or impaired elimination may all contribute to increased blood concentration of lidocaine. due to the low systemic absorption of topically-applied diclofenac sodium, overdosage of diclofenac sodium is unlikely.

Description:

Diclona gel (lidocaine 4.5%, diclofenac 1%) is comprised of a gel inside of a 3.5oz tube containing 4.5% lidocaine and 1% diclofenac sodium. inactive ingredients: aloe barbadensis (aloe vera) leaf juice, arnica montana flower extract, boswellia serrata extract, carbomer, dimethyl sulfoxide, ethylhexylglycerin, eucalyptus globulus leaf oil, methylsulfonylmethane, phenoxyethanol, prunus amygdalus dulcis (sweet almond) oil, sd alcohol 40-b, sorbitol, triethanolamine, water.

Clinical Pharmacology:

Pharmacodynamics lidocaine is an amide-type local anesthetic agent. the penetration of lidocaine into intact skin after application of diclona gel is sufficient to produce analgesic effect, but less than the amount necessary to produce a complete sensory block. 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 the amount of lidocaine systemically absorbed from diclona gel is directly related to both the duration of application and the surface area over which it is applied. when diclona gel is applied topically, diclofenac sodium is absorbed into the epidermis. the systematic bioavailability after topical application of diclofenac sodium is lower than after oral dosing. distribution at concentrations produced by application of diclona gel, approximately 70% of the lidocaine dose is reported to be bound to plasma prot Read more...

eins, primarily alpha-1-acid glycoprotein. at higher plasma concentrations (1 to 4 mcg/ml of free base), the plasma protein binding of lidocaine is concentration dependent. diclofenac sodium binds tightly to serum albumin. metabolism it is not known if diclona gel is metabolized in the skin. metabolism of diclofenac sodium following topical administration is thought to be similar to that after oral administration. the small amounts of diclofenac sodium and its metabolites appearing in the plasma following topical administration makes the quantification of specific metabolites imprecise. excretion lidocaine and its metabolites are excreted by the kidneys. less than 10% of lidocaine is excreted unchanged. the half-life of lidocaine elimination from the plasma following iv administration is 81 to 149 minutes (mean 107 Â± 22 sd, n = 15). the systemic clearance is 0.33 to 0.90 l/min (mean 0.64 Â± 2 max max 0.18 sd, n = 15). diclofenac sodium and its metabolites are excreted mainly in the urine after oral dosing.

How Supplied:

Diclona gel is available as the following: 1 tube, 3.5oz ndc 53225-1070-1 store at 25Â°c (77Â°f); excursions permitted to 15Â°-30Â°c (59Â°-86Â°f). [see usp controlled room temperature]. for more information, contact terrain pharmaceuticals. info@terrainrx.com manufactured for: terrain pharmaceuticals reno, nv 89501 printed in the u.s.a

Package Label Principal Display Panel:

72189-390-35

Comments/ Reviews:

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